[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"M.D. Anderson Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":519},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,577,0,25,[9,40,61,84,104,123,143,160,184,206,225,251,271,292,310,329,350,368,385,405,425,445,463,480,499],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100054066","phase-2-a-phase-2-trial-to-assess-safety-and-efficacy-of-tofacitinib-2-cream-in-the-treatment-of-cutaneous-t-cell-lymphoma-ctcl-stages-ia-ib-and-iia-100054066",false,"NCT06698822","A Phase 2 Trial to Assess Safety and Efficacy of Tofacitinib 2% Cream in the Treatment of Cutaneous T-cell Lymphoma (CTCL), Stages IA, IB, and IIA","Inclusion Criteria:\n\n* Age ≥18 years at screening visit. Because limited dosing and adverse event data are currently available on the use of tofacitinib in participants \\\u003C18 years of age, children are excluded from this study.\n\n  * Have a clinical diagnosis of cutaneous T-cell lymphoma (CTCL) stage IA, IB, or IIA including documentation of a skin biopsy with histological findings consistent with CTCL.\n  * For stage IIA, only participants with a classification of N0 (no clinically abnormal peripheral lymph nodes) or N1 (clinically abnormal lymph node(s) histopathology Dutch grade 1 or NCI LN0-2) can be enrolled.\n  * Participants must be B0 (absence of significant blood involvement: .5% of peripheral blood lymphocytes of \\\u003C250\u002FmcL are atypical.\n  * Have at least 2 distinct lesions that have either failed or recurred despite treatment with 1 previous standard therapy.\n  * ECOG performance status ≤ 2 (Karnofsky .60%)\n  * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n  * The effects of tofacitinib on the developing human fetus are unknown. Available data with tofacitinib in its oral formulation in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Therefore, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n    1. Postmenopausal (no menses in greater than or equal to 12 consecutive months)\n    2. History of hysterectomy or bilateral salpingo-oophorectomy\n    3. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)\n    4. History of bilateral tubal ligation or another surgical sterilization procedure\n  * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of tofacitinib administration.\n\n    * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tofacitinib\n\n  * Skin infection and\u002For skin ulceration at screening and baseline visit\n  * Any subject with a diagnosis of active malignancy or a cancer requiring treatment of expected to require treatment during the course of the trial (not including basal cell carcinoma, squamous cell carcinoma of the skin, malignant melanoma in situ, or cervical carcinoma in situ)\n  * Any uncontrolled or serious underlying disease or medical or surgical condition that may interfere with interpretation of the trial results and\u002For place the subject at significant risk according to investigator discretion including but not limited to severe cardiac, psychiatric, hematologic, and thyroid conditions\n  * History of Stage IIB or greater CTCL, or stage IIA CTCL with history of stage N2 (Dutch Grade 2 or NCI LN3 or greater), or with \\>5% circulating Sezary cells\n  * History of aggressive CD8+ CTCL disease\n  * Having received one of the following treatments within the specified timeframes (calculated from baseline visit):\n\n    * In the past 12 weeks: Total Skin Electron Beam Therapy (TSEBT)\n    * In the past 8 weeks: topical imiquimod\n    * In the past 4 weeks: topical corticosteroids, topical chemotherapy, topical retinoids, local radiation therapy, UVB therapy, PUVA, photopheresis, systemic retinoids, systemic corticosteroids, interferon inducers, systemic chemotherapeutic agents\n  * Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia\n  * Participants who are receiving any other investigational agents\n  * Participants with uncontrolled intercurrent illness\n  * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n  * Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Pregnant women are excluded from this study because the effects of tofacitinib on the developing human fetus are unknown. As there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with tofacitinib, breastfeeding should be discontinued if the mother is treated with tofacitinib. These potential risks may also apply to other agents used in this study.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To study the safety and effectiveness of tofacitinib 2% cream in treating early-stage CTCL.",[26],"Cutaneous T-Cell Lymphoma","RECRUITING","2026-07-10",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2025-03-10",{"date":35,"type":20},"2027-10-19",{"name":37,"class":38},"M.D. Anderson Cancer Center","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":39},"100053774","phase-1-a-phase-1-trial-of-safety-and-initial-efficacy-of-vagal-nerve-blockade-for-cancer-induced-cachexia-in-patients-with-metastatic-pancreatic-adenocarcinoma-100053774","NCT07700212","A Phase 1 Trial Of Safety And Initial Efficacy Of Vagal Nerve Blockade For Cancer-Induced Cachexia In Patients With Metastatic Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Patients with metastatic pancreatic cancer.\n* Must have adenocarcinoma component (presence of combined histology is acceptable, as long as adenocarcinoma is present).\n* Weight loss from baseline of at least 5% (Baseline weight can be anytime from diagnosis onward).\n* Must have a tissue-based confirmation of diagnosis available. Tissue does not need to be a metastasis; primary tumor or prior surgery are acceptable sources.\n* Must have had progression of disease after one prior line of therapy in the metastatic setting.\n* Must be receiving or plan to receive another line of therapy in the metastatic setting. o If therapy is being administered outside MD Anderson, the patient is still eligible for this trial. o Enrollment onto a therapeutic clinical trial as this second line therapy is not explicitly excluded.\n* Must have triple ECG results available. Patients will be ineligible if they present: o Second- or third-degree block.\n\n  * Prolonged QT wave.\n  * Atrial fibrillation or flutter.\n  * Uncontrolled ventricular fibrillation or flutter.\n  * Premature ventricular contractions (PVC).\n\nExclusion Criteria:\n\nExclusion Criteria\n\n* History of cervical vagotomy on the right side of neck.\n* Known structural abnormalities on the right side of neck, including but not limited to situs inversus, bulky R-neck lymphadenopathy, etc., that in the investigators' opinion would lead to inability to correctly place the device onto the vagus nerve.\n* Implanted electrical device that passes through the neck (e.g.: cranial implant with battery pack in chest, and wires running through the neck).\n* Metal implants in the neck, including the cervical spine.\n* Recent (6 months or less) nerve block or botox injections to the head or neck.\n* Pain specifically localized to the treatment area, the right side of the neck.\n* Prior severe cerebrovascular disease (e.g., intracranial aneurysm, intracranial hemorrhage, stroke).\n* Prior severe cardiac disease, including but not limited to coronary artery disease (CAD), prior myocardial infarction (MI), uncontrolled congestive heart failure (CHF).",{"count":47,"type":20},10,[49],"PHASE1","The goal of this clinical research study is to learn about the safety and tolerability of the OnVagus device when used by patients who have metastatic pancreatic cancer and are receiving chemotherapy.",[52],"Metastatic Pancreatic Adenocarcinoma","NOT_YET_RECRUITING","2026-07-08",{"date":30,"type":31},{"date":57,"type":20},"2026-09-30",{"date":59,"type":20},"2028-12-30",{"name":37,"class":38},{"id":62,"slug":63,"hasResults":12,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":12,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":39},"100522672","phase-1-a-pilot-presurgical-trial-of-regn5678-anti-psma-x-cd28-in-patients-with-high-risk-localized-prostate-cancer-followed-by-radical-prostatectomy-100522672","NCT06085664","A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy","A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy","Inclusion Criteria:\n\n* Men ≥ 18 years of age\n* Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of Gleason 8 or greater. Prostate biopsy within 3 months of screening is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas or mixed histologies are not eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1\n* No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to enrollment\n* Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection\n* No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate \\[TURP\\]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy\n* Hemoglobin ≥ 11 g\u002FdL\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate \\> 50 mL\u002Fmin\u002F1.73 m\\^2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria\n* Total bilirubin ≤ 1.5 x ULN\n\n  * NOTES: Patients with Gilbert's syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert's syndrome must be documented appropriately as past medical history\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Alkaline phosphatase (ALP) ≤ 2.5 x ULN\n* Consent to MD Anderson laboratory protocol PA13-0291\n* Willing and able to comply with clinic visits and study-related procedures\n* Provide informed consent signed by study patient\n* To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug\n\nExclusion Criteria:\n\n* Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists\u002Fantagonists\n* Currently enrolled in another interventional study\n* Concurrent treatment with systemic corticosteroids (prednisone dose \\> 10 mg per day or equivalent) or other immunosuppressive drugs \\\u003C 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted\n* History of or known or suspected autoimmune disease (exception\\[s\\]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed)\n* Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Patients with known HIV infection which is well-controlled (undetectable viral load by HIV ribonuclecid acid \\[RNA\\] polymerase chain reaction \\[PCR\\]) and CD4 counts greater than 350 are permitted to participate\n* History of clinically significant cardiovascular disease including, but not limited to:\n\n  * Myocardial infarction or unstable angina ≤ 6 months prior to treatment initiation\n  * Clinically significant cardiac arrhythmia\n  * Deep vein thrombosis, pulmonary embolism, stroke ≤ 6 months prior to treatment initiation\n  * Congestive heart failure (New York Heart Association class III-IV)\n  * Pericarditis\u002Fclinically significant pericardial effusion\n  * Myocarditis\n  * Endocarditis\n* History of major implant(s) or device(s), including but not limited to:\n\n  * Prosthetic heart valve(s)\n  * Artificial joints and prosthetics placed ≤ 12 months prior to treatment initiation\n  * Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed\n* Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) ≤ 2 years prior to enrollment\n* Has received major surgery within 14 days of first administration of study drug\n* Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living \\[ADLs\\]) or uncontrolled seizures in the year prior to first dose of study therapy\n* Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (past 5 years)\n* Receipt of a live vaccine within 4 weeks of planned start of study medication\n* Prior allogeneic stem cell transplantation or recipients of organ transplants at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment\n* Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study","MALE",{"count":70,"type":20},42,[49,23],"To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.",[74,75],"Prostate Cancer","Radical Prostatectomy","2026-07-01",{"date":78,"type":31},"2026-07-02",{"date":80,"type":31},"2023-12-04",{"date":82,"type":20},"2028-06-30",{"name":37,"class":38},{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":39},"100636490","phase-2-phase-2-study-of-mosunetuzumab-in-patients-with-chronic-lymphocytic-leukemia-with-positive-mrd-100636490","NCT07566364","Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive MRD","A Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive Measurable Residual Disease","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if ALL the following criteria apply:\n\n1. Age ≥18 years at the time of signing the Informed Consent Form\n2. Ability to comply with the study protocol and procedures and required\n3. Patients must have received ≥2 prior lines of systemic therapy, including the current BTKi\n4. Patients with high-risk CLL\u002FSLL defined as the presence of any of the following factors:\n\nprogression of disease on prior covalent BTKi, or progression of disease on or within 6 months of venetoclax-based treatment, or 3 or more prior treatments, or presence of del(17p) and\u002For TP53 mutation, or unmutated IGHV e. Patients with CLL\u002FSLL on continuous BTKi therapy (covalent or non-covalent) for ≥12 months and detectable bone marrow MRD4 by ClonoSEQ f. Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1 g. Adequate BM function independent of growth factor or transfusion support, within 2 weeks of screening, at screening as follows unless cytopenia is clearly due to marrow involvement of CLL:\n\n* Platelet count ≥50,000\u002FµL; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), platelet count should be\n\n  ≥30,000\u002Fmm3\n* ANC ≥1.5x109 cells\u002FL unless neutropenia is clearly due to marrow involvement of CLL (per the discretion of the investigator)\n* Total hemoglobin ≥10 g\u002FdL unless anemia is due to marrow involvement of CLL (per the discretion of the investigator) h. Adequate liver function as indicated by a total bilirubin ≤1.5 x ULN, AST, and ALT ≤3 times the institutional ULN value\n* In patients with CLL involvement of the liver; AST and ALT \\\u003C5 times institutional ULN and total bilirubin \\\u003C3 times institutional ULN i. In patients with Gilbert syndrome: total bilirubin \\\u003C3 times institutional ULN j. Adequate renal function: serum creatinine ≤1.5 ULN or eGFR ≥50 mL\u002Fmin k. Life expectancy \\>6 months l. Resolution to Grade ≤1 for clinically significant toxicities attributable to prior therapies before commencement of the first study drug administration with the following exceptions:\n* Any grade alopecia or vitiligo\n* Grade 2 peripheral sensory or motor neuropathy\n* Endocrinopathy managed and controlled using replacement therapy m. Patients who have a negative HIV test at screening, with the following exception.\n* Patients with a positive HIV test at screening are eligible provided that, prior to enrollment, they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200\u002FμL, have an undetectable viral load, and have not had a history of an AIDSdefining opportunistic infection within the past 12 months.\n\n  n. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C1% per year, and agreement to refrain from donating eggs, during the treatment period and for at least 3 months after the last dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable). A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, or post ovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n\n  o. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:\n* With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 2 months after the final dose of tocilizumab (if applicable), to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Patients with high disease burden, defined as having either absolute lymphocyte count \\>5 x 109 cells\u002FL, or largest lymph node \\>2 cm, or bone marrow with \\>50% CLL involvement\n2. Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable). Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. If a serum pregnancy test has not been performed within 14 days prior to receiving first study treatment, a negative urine pregnancy test result (performed within 7 days prior to study treatment) must be available.\n\nb. Participants who previously received any of the following treatments prior to study entry:\n\n* Treatment with mosunetuzumab or other CD20\u002FCD3-directed bispecific antibodies\n* Allogeneic stem cell transplant within 90 days of enrollment or with active GVHD c. Participants who have received any of the following treatments, whether investigational or approved, within the respective time periods prior to initiation of study treatment:\n* Radiotherapy within 2 weeks prior to the first dose of study treatment\n* CAR T-cell therapy within 90 days before first study treatment\n* Use of monoclonal antibodies or antibody-drug conjugates within 4 weeks prior to first study treatment d. Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dose of study treatment\n* Systemic corticosteroid treatment ≤25 mg\u002Fday prednisone or equivalent and inhaled corticosteroids are permitted.\n* Administration of acute, low-dose, systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B-symptoms) is permitted.\n* The use of mineralocorticoids for management of orthostatic hypotension and corticosteroids for management of adrenal insufficiency is permitted. e. Any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment. f. Prior cancer immunotherapy not explicitly described in this protocol g. Received a live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment h. Transformation of CLL to aggressive NHL (e.g., Richter's transformation, prolymphocytic leukemia, or diffuse large B-cell lymphoma \\[DLBCL\\]) or CNS involvement by CLL i. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins) j. History of prior malignancy, except for conditions as listed below if patients have recovered from the acute side effects incurred as a result of previous therapy:\n* Malignancies treated with curative intent and with no known active disease present for ≥2 years before enrollment\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n* Adequately treated cervical carcinoma in situ without evidence of disease\n* Surgically\u002Fadequately treated low grade, early stage, localized prostate cancer without evidence of disease k. Participants with infections requiring IV treatment with antibiotics or hospitalization (Grade 3 or 4) within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment l. Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:\n* Significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina)\n* Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)\n* Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis\n* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed.\n* Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible only for the expansion cohort m. History of confirmed progressive multifocal leukoencephalopathy (PML) n. Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology)\n* Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening.\n* These participants must be willing to undergo monthly DNA testing and appropriate prophylactic antiviral therapy as indicated. o. Acute or chronic hepatitis C virus (HCV) infection\n* Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation. p. Known or suspected chronic active Epstein-Barr virus infection q. Known or suspected history of HLH r. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n* Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n* Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* Participants with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible.\n* Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review by the investigator. s. Evidence of other clinically significant uncontrolled condition(s) including but not limited to active or uncontrolled systemic infections (e.g., viral, bacterial, or fungal) t. Recent major surgery within 4 weeks prior to first study treatment administration, except for protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies) u. Participants with a left ventricular ejection fraction (LVEF) \\\u003C40% v. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study",{"count":92,"type":20},30,[23],"The purpose of this study is to assess the therapeutic efficacy of mosunetuzumab, a bispecific antibody targeting CD20 and CD3 in patients who have detectable chronic lymphocytic leukemia (CLL) after receiving Bruton's tyrosine kinase inhibitors (BTKis) for at least 6 months and have no clinical or laboratory evidence of disease progression.",[96],"Lymphocytic Leukemia","2026-06-29",{"date":76,"type":31},{"date":100,"type":20},"2026-10-01",{"date":102,"type":20},"2030-10-31",{"name":37,"class":38},{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":39},"100617237","phase-2-phase-2-trial-of-lisocabtagene-maraleucel-for-minimal-residual-disease-in-patients-with-large-b-cell-lymphoma-100617237","NCT07316010","Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma","Inclusion Criteria:\n\nPatients must meet the following criteria for study entry:\n\n2\\. Age ≥18 years 3. Histologically diagnosed 4. Diffuse large B-cell lymphoma, not otherwise specified (NOS) or 5. High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) 6. International Prognostic Index score ≥ 3 or 1-2 with LDH \\> 1.3 x ULN and\u002For bulky disease (single lesion of ≥ 7cm) 7. Received first line standard of care anthracycline-based chemoimmunotherapy for 6 cycles (with or without 2 more cycles of rituximab) for previously untreated disease\n\n* R-CHOP (cyclophosphamide, doxorubicin, vincristine sulfate, and prednisone)\n* DA-EPOCH-R\n* Polatuzumab-R-CHP 8. Achieved complete metabolic response by Lugano criteria4 at the end of treatment response evaluation after first line treatment\n* Or PR only if suitable for observation, defined as either negative biopsy or deemed too small or not amenable to biopsy 9. Had a response assessment within 8 weeks following completion of first line standard of care treatment 10. Detectable MRD after first line treatment (regardless of the ctDNA level) by Foresight CLARITY™12 11. Performance status ≤2 on the ECOG scale (section 6.2.5) 12. Adequate organ and marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥1.0 × 109 \u002FL\\*\n\n  \\*Growth factor permitted during screening\n* Platelet count ≥75 × 109 \u002FL\n* Hemoglobin ≥ 8 g\u002FdL\n* Total bilirubin ≤ 3 ULN, unless consistent with Gilbert's syndrome\n* AST and ALT ≤ 3x upper limit of normal (ULN)\n* Alkaline phosphatase \\\u003C 2.5 ULN\n* Creatinine clearance \\>40 ml\u002Fmin calculated by modified Cockcroft-Gault formula or estimated GFR (eGFR) \\> 40 ml\u002Fmin\u002F1.73m2\n* Cardiac ejection fraction ≥ 40%, no evidence of clinically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings 13. All subjects must\n* Agree to refrain from donating blood while on study treatment, and for at least 12 months following the last dose of study treatment.\n\n  14\\. The effects of liso-cel on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n* Postmenopausal (non-chemically induced menopause in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\n  15\\. Females of childbearing potential (FCBP) must:\n* Have 2 negative pregnancy tests as verified by the Investigator (one negative serum beta-human chorionic gonadotropin \\[ß-hCG\\] pregnancy test result at screening, and within 7 days prior to the first dose of LD chemotherapy). This applies even if the subject practices true abstinence2 from heterosexual contact.\n* Either commit to true abstinence from heterosexual contact (which must be reviewed monthly and source documented) or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the LD chemotherapy.\n* Agree to abstain from breastfeeding during study participation and for at least 12 months following LD chemotherapy.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n  16\\. Male subjects must:\n* Male Practice true abstinence (which must be reviewed monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for 12 months after LD chemotherapy even if he has undergone a successful vasectomy.\n\n  17\\. Willing and able to comply with the protocol treatment and procedures. 18. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nSubjects will be ineligible for this study if they meet any of following criteria:\n\n1. Having radiologically confirmed relapsed\u002Frefractory disease.\n2. Have not recovered from non-hematological AEs due to prior first line therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n3. Known central nervous system lymphoma or leptomeningeal disease.\n\n   • Suspicious case at end of treatment from first line treatment should be evaluated with brain MRI with or without lumber puncture.\n4. Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 2 years and felt to be at low risk for recurrence by the treating physician, except:\n\n   * Adequately treated localized non-melanoma skin cancer without evidence of disease.\n   * Adequately treated localized prostate cancer without evidence of disease.\n   * Adequately treated localized breast cancer without evidence of disease.\n   * Adequately treated cervical carcinoma in situ without evidence of disease.\n5. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at undue risk.\n6. Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2.\n7. Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. The treatment and monitoring of hepatitis B will follow the institutional standard of practice. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.\n8. History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.\n9. History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \\>10mg\u002Fday of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.\n10. Clinically significant cardiovascular diseases such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification. Subjects with controlled, asymptomatic heart failure during screening can enroll on study.\n11. History or presence of clinically significant central nervous system (CNS) pathology such as epilepsy (a seizure disorder), a seizure within the past 2 years prior to signing the ICF, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, Grade 3 or higher tremor, cerebellar disease, organic brain syndrome, or psychosis.\n12. Lactating or pregnant subjects. Pregnant women are excluded from this study for unknown potential for teratogenic or abortifacient effects by liso-cel. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with liso-cel, breastfeeding should be discontinued if the mother is treated with liso-cel. These potential risks may also apply to other agents used in this study.\n13. Had blood transfusion within 14 days prior to first dose of LDC.\n14. Administration of any investigational agent within 28 days of first dose of study drug.\n15. Patients who have undergone major surgery within 28 days or minor surgery within 3 days of first dose of study drug.\n16. Administration of a live, attenuated vaccine within 4 weeks before lymphodepleting treatment administration or anticipation that such a live, attenuated vaccine will be required during the study.\n17. Patients taking chronic corticosteroids for other diseases, unless administered at a dose equivalent to \\\u003C 10 mg\u002Fday prednisone. For corticosteroids, prednisolone \\>20 mg daily (or equivalent) qualifies as immunosuppressive and thus is excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma-related symptoms, including during screening, and for prophylaxis or AE management during the trial.\n18. Patients who have concern for the accurate assessment of neuro toxicity.\n19. Patients who have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.",{"count":111,"type":20},50,[23],"The goal of the main clinical research study is to learn if treatment with a chimeric antigen receptor (CAR) T-cell therapy called lisocabtagene maraleucel (liso-cel) can help to prevent recurrence of large B-cell cell lymphoma in patients who have achieved complete response (CR) after standard first-line therapy but have tested positive for lymphoma DNA. CAR T therapy is a type of treatment that uses your own immune cells to fight your cancer. The safety of this treatment will also be studied.",[115],"Large B-cell Lymphoma",{"date":117,"type":31},"2026-06-30",{"date":119,"type":31},"2026-03-17",{"date":121,"type":20},"2031-03-21",{"name":37,"class":38},{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":39},"100644935","phase-1-phase-1-study-of-kite-753-in-rr-b-cell-all-100644935","NCT07674823","Phase 1 Study Of KITE-753 in R\u002FR B-Cell ALL","A Phase 1 Study Evaluating The Safety And Efficacy Of KITE-753, Autologous Anticd19\u002FCD20 CAR T-Cell Therapies, In Patients With Relapsed And\u002FOr Refractory B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patients ≥18 years of age with relapsed and\u002For refractory B-cell ALL after 1 or more lines of therapy with ≥5% and \\\u003C75% bone marrow blasts at the time of consent\n* Blasts should be positive (≥1%) for either CD19 or CD20 as assessed by flow-cytometry or positive for either CD19 or CD20 by immunohistochemistry\n* Patients with Philadelphia chromosome-positive ALL are eligible if they are intolerant or have failed 2 lines of any TKI or one line of second-generation TKI\n* ECOG performance status ≤2\n* Adequate organ function: Creatinine clearance \\>50 ml\u002Fmin, direct bilirubin ≤1.5 mg\u002FdL, AST\u002FALT ≤5.0 x ULN (except in patients with leukemia involvement where up to 10 x ULN is allowed), left ventricular ejection fraction \\>40%\n* The effects of KITE-753 on the developing human fetus are unknown. For this reason and because chemotherapy used in this trial is known to be teratogenic, women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least 12 months after the last dose of study treatment. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after the last dose of study treatment.\n* Ability to understand and willingness to sign a written informed consent document\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Patients who have received prior CAR T-cell therapy or other cell therapies\n* History of CTCAE grade 4 neurologic event or grade 4 CRS (Lee 2014 criteria) with prior CD19-directed therapy\n* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requires IV antimicrobials for management Note: Simple urinary tract infections and uncomplicated bacterial or viral upper respiratory tract infections are permitted if the participant is responding to active treatment and satisfies the criteria of being afebrile for 48 hours (i.e., temperature \\\u003C 38°C).\n* Symptomatic CNS disease (i.e. cranial nerve palsies) at the time of enrollment. Patients could have prior history of CNS disease but no symptomatic CNS disease at the time of study enrollment.\n* Presence of CNS-3 disease (defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3) with or without neurological changes, and presence of CNS-2 disease (defined as detectable cerebrospinal blast cells in a sample of CSF with \\\u003C5 WBCs per mm3) with neurological changes Note: Subjects with CNS-1 (no detectable leukemia in the CSF) and those with CNS-2 without clinically evident neurological changes are eligible to participate in the study.\n* History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia (grade 2 or higher memory impairment per CTCAEv5.0), Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (grade ≥3) CNS events including ICANS from T cell engager therapies.\n* Acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment\n* Diagnosis of Burkitt's leukemia\u002Flymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis\n* Current uncontrolled autoimmune disease\n* History of Hemophagocytic lymphohistiocytosis \u002F Macrophage activation syndrome\n* Prior medication:\n\n  * Salvage systemic therapy (including chemotherapy, TKIs for Ph+ ALL, and blinatumomab) within 1 week or 5 half-lives (whichever is shorter) prior to enrollment\n  * Treatment with alemtuzumab within 6 months prior to enrollment, clofarabine or cladribine within 3 months prior to enrollment, or PEG-asparaginase within 3 weeks prior to enrollment\n  * Donor lymphocyte infusion (DLI) within 28 days prior to enrollment\n  * Any drug used for GVHD within 4 weeks prior to enrollment (e.g., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide), or immunosuppressive antibody used within 4 weeks prior to enrollment (e.g., antiCD20, anti-tumor necrosis factor, anti-interleukin 6 or anti-interleukin 6 receptor)\n  * Corticosteroid therapy at a pharmacologic dose (\\>5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to enrollment\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients unable\u002Funwilling to sign informed consent form\n* Because no dosing or adverse event data are currently available on the use of KITE-753 in patients \\\u003C18 years of age, children are excluded from this study\n* Human Immunodeficiency Virus (HIV)-positive unless taking appropriate anti-HIV medications, having an undetectable viral load by qPCR, and a CD4 count ≥200 cells\u002FµL\n* Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants, secondary to treatment of the mother with KITE753, breastfeeding should be discontinued if the mother is treated with KITE-753\n* WOCBP must have a negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization\n* Patients of either sex who are not willing to practice highly effective birth control from the time of informed consent through 12 months after lymphodepleting chemotherapy or the KITE-753 administration, whichever is longer",{"count":131,"type":20},18,[49],"The goal of this clinical research study is to find the recommended dose of KITE-753 in patients with relapsed\u002Frefractory B-cell ALL. The safety of KITE-753 will also be studied.",[135],"B-cell Acute Lymphoblastic Leukemia","2026-06-26",{"date":117,"type":31},{"date":139,"type":20},"2026-12-31",{"date":141,"type":20},"2031-04-01",{"name":37,"class":38},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":157,"leadSponsor":159,"locationsCount":39},"100644871","phase-2-a-phase-2-trial-of-the-combination-of-zanubrutinib-sonrotoclax-and-obinutuzumab-for-patients-with-treatment-nave-chronic-lymphocytic-leukemia-100644871","NCT07674810","A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia","Inclusion Criteria:\n\n1. Patients with a diagnosis of previously untreated CLL\u002FSLL meeting iwCLL 2018 indication for treatment (Note: patients who receive steroids and\u002For CD20 mAb for cytoreduction in those patients presenting with significantly elevated WBC count or significant adenopathy\u002Forganomegaly and those who previously received steroids\u002FCD20 mAb for immune cytopenias are eligible to enroll; Washout of 3 months applies for CD20 mAb and dose of prednisone (or equivalent) should be less than 20 mg\u002Fday by day 1 of study initiation)\n2. Age greater than or equal to 18 years of age\n3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2\n4. Adequate hepatic function a. Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease or documented disease involvement of liver (In pts with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin ≤1.5 x ULN are eligible) b. ALT and AST ≤3.0 x ULN, or ≤5.0 x ULN if documented disease involvement of liver\n5. Adequate renal function a. Adequate renal function defined by a value ≥30 mL\u002Fmin determined via estimated GFR calculated according to the CKD-EPI equation\n6. Adequate hematologic function\n\n   a. Platelet count ≥50 x109 \u002FL and hemoglobin ≥8 g\u002FdL (≥80 g\u002FL). Platelet and hemoglobin requirements are independent of transfusions within 7 days of screening assessment and first dose of study drugs.\n\n   b. Absolute neutrophil count ≥0.75 x 109 \u002FL. Absolute neutrophil count is independent of growth factor support within 7 days of screening assessment and first dose of study drugs.\n7. Adequate coagulation function a. INR ≤1.5 x ULN and aPTT ≤1.5 x ULN\n8. Ability to swallow tablets and comply with outpatient treatment, laboratory monitoring, and required clinic visit for the duration of study participation\n9. Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 24 hours prior to the first dose of study drugs and must agree to use an effective contraception method (combined hormonal contraception, progestogenonly hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, or vasectomized partners) during the study and for at least 18 months following the last dose of study drug. Women of non-childbearing potential are those who are postmenopausal greater than 2 year or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use an effective contraceptive method (condom or vasectomy) during the study and for at least 18 months following the last dose of study drug. Egg and sperm donation should be refrained for at least 18 months from the last dose of study drug, respectively.\n\nExclusion Criteria:\n\n1\\. Major surgery within 4 weeks prior to the first dose of study drugs 2. Uncontrolled active systemic infection 3. Known positive serology for human immunodeficiency virus (HIV) 4. Active hepatitis B infection (defined as the presence of detectable HBV DNA, HBe antigen or HBs antigen). Patients with serologic evidence of prior vaccination (HBsAg negative, anti-HBs antibody positive, anti-HBc antibody negative) are eligible. Patients who are HBsAg negative\u002FHBsAb positive but HBcAb positive are eligible, provided HBV DNA is negative and they are willing to take appropriate antiviral prophylaxis 5. Active hepatitis C infection (defined as detectable hepatitis C RNA in plasma by PCR) 6. Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible 7. Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with \\>20 mg daily of prednisone or equivalent 8. Clinically significant, uncontrolled cardiovascular disease (≥3 NYHA heart failure, uncontrolled or symptomatic arrhythmias), or myocardial infarction within 6 months, or stroke within 6 months, or intracranial bleeding within 6 months prior to start of study drugs 9. Uncontrolled hypertension defined as 2 consecutive systolic blood pressure ≥160 mmHg and \u002For diastolic blood pressure ≥100 mmHg within 3 months 10. History of Mobitz II second degree or third-degree heart block without a permanent pacemaker in place 11. Prolongation of the QT interval corrected for heart rate (QTcF) \\>480 msec. Note: Patients with QTcF \\>480 msec should have EKG repeated. If QTcF again is \\>480 msec, then the patient should be referred to cardiology for evaluation. Patients can be enrolled later if cleared by cardiology and repeat QTcF less than 480 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT\u002F(RR0.33)\n\n1. Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n2. Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker 12. Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment 13. Concurrent use of warfarin or another vitamin K antagonist 14. Receiving treatment with a strong CYP3A inhibitor or strong CYP3A inducer ≤14 days or 5 half-lives, whichever is longer, before the first dose of study treatment(s) OR requiring long-term use of strong CYP3A inhibitors or inducers.\n\n   15\\. Patients consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment 16. Known central nervous system involvement by CLL\u002FSLL 17. Active second malignancy unless in remission and with life expectancy \\>2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma \"in situ\" of the cervix or breast who are eligible even if diagnosed within 2 years. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center, and after consultation with the Principal Investigator. 18. Known hypersensitivity to any component or excipient of study drugs 19. Malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drugs 20. Receipt of live-virus vaccines within 4 weeks prior to starting study drugs 21. History of bleeding diathesis and\u002For history of known bleeding disorder including hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention 22. Known prolymphocytic leukemia or history of, or currently suspected, Richter transformation (biopsy based on clinical suspicion may be needed to rule our transformation)",{"count":150,"type":20},40,[23],"The goal of this clinical research study is to learn if the combination of zanubrutinib, sonrotoclax, and obinutuzumab can help to control previously untreated CLL\u002FSLL.",[154],"Chronic Lymphocytic Leukemia",{"date":117,"type":31},{"date":139,"type":20},{"date":158,"type":20},"2029-04-30",{"name":37,"class":38},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":39},"100644990","oncologic-timely-palliative-care-and-remote-monitoring-with-electronic-assessments-and-telehealth-on-target-100644990","NCT07674797","Oncologic Timely Palliative Care And Remote Monitoring With Electronic Assessments And Telehealth (ON-TARGET)","Eligibility Criteria\n\n* Age ≥ 18\n* Outpatients who are within 12 weeks of diagnosis of metastatic solid tumors and seen by one of the participating medical oncologists\n* Eastern Cooperative Oncology Group Performance Status 0.2\n* Able to speak English or Spanish\n\nExclusion Criteria:\n\n. Cognitive impairment in the opinion of the oncologist necessitating need for a surrogate decision making.\n\n• Previously seen by SPC team at UT MD Anderson",{"count":167,"type":20},300,[169],"NA","To examine how we can provide supportive care for patients with advanced cancer better tailored to their needs",[172,173,174,175,176],"Oncologic","Palliative Care","Remote Monitoring","Electronic Assessments","Telehealth","2026-06-24",{"date":117,"type":31},{"date":180,"type":20},"2026-11-22",{"date":182,"type":20},"2034-06-30",{"name":37,"class":38},{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":190,"minAge":17,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":39},"100617415","phase-1-phase-ib-study-of-avutometinib-defactinib-and-everolimus-in-ras-pathway-mutant-endometrial-cancer-100617415","NCT07318324","Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer","Eligibility Criteria\n\n1. Participants must have histologically or cytologically confirmed recurrent RAS mutant endometrial cancer. RAS pathway gene activating mutations include KRAS, NRAS, HRAS, BRAF, MEK1, and MEK2 activating mutations. Any endometrial histology is permitted, including endometrioid, clear cell, mesonephric, and serous.\n2. Participants must have received prior immune checkpoint inhibition treatment alone or in combination.\n3. Unlimited prior systemic therapies are permitted, including any number of prior MEK inhibitor regimens.\n4. Ability to understand and willingness to sign a written informed consent document.\n5. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n6. ECOG performance status of 0-1\n7. The effects of avutometinib and defactinib on the developing human fetus are unknown. For this reason, women of child-bearing potential must have a negative urine or serum pregnancy test within 72 hours of starting study and agree to use adequate contraception prior to study entry, for the duration of study participation, and for 3 months after the last dose of study drug. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n   The use of hormonal contraception methods is not recommended for this study. Approved methods of birth control are as follows: Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n8. Participants must have measurable disease as defined by RECIST v1.1\n9. Age ≥18 years.\n10. Participants must have adequate organ and marrow function as defined below:\n\n    absolute neutrophil count ≥1,000\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ 1.5x institutional ULN AST(SGOT)\u002FALT(SGPT) ≤3× institutional ULN creatinine clearance \\> 50 ml\u002Fmin hemoglobin \\> 9 g\u002FdL If a red blood cell transfusion or erythropoiesis-stimulating agent has been administered the hemoglobin must remain stable and ≥ 9 g\u002FdL for at least 1 week prior to first dose of study intervention.\n11. Creatine phosphokinase (CPK) ≤ 2.5 x ULN.\n12. Adequate cardiac function with left ventricular ejection fraction ≥ 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n\n    * QTc interval ≤ 460 ms using Fredericia's QT correction formula (at baseline from ECGs). NOTE: Participants with a right or left bundle branch block are allowed to have a QTc \\> 460ms.\n    * Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class I or II and stage A or B\n13. For dose expansion cohort: the participant must be willing to undergo biopsy procedure at screening and on treatment.\n\nExclusion Criteria\n\n1. Participants who are pregnant or lactating.\n2. Participants with sarcoma components of their endometrial cancer, except carcinosarcoma.\n3. Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.\n4. Participation in an interventional anti-cancer study (clinical trial) within 3 weeks prior to cycle 1 day 1\n5. Major surgery within four weeks before cycle 1 day 1.\n6. A history of congestive heart failure (CHF) of NYHA Class ≥3, or history of myocardial infarction (MI) within 3 months.\n7. Participants with a history of severe obstructive pulmonary disease, pulmonary hypertension, and\u002For pulmonary fibrosis in the opinion of treating MD\n8. History of medically significant rhabdomyolysis in the opinion of treating MD.\n9. For participants with prior MEK inhibitors, any history of or ongoing Grade 4 toxicity deemed related to MEK inhibitor\n10. Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; participants with controlled infection in the opinion of treating MD or on prophylactic antibiotics are permitted in the study.\n11. Activr Hepatitis B, or C infection as indicated by detectable viral load. Known HIV seropositivity with detectable viral load. Participants with an undetectable viral load are eligible for the trial.\n12. Any underlying condition that would significantly interfere with the absorption of an oral medication or inability to take oral medications in the opinion of treating MD\n13. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n14. Participants with symptomatic brain lesions\n15. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation). Subjects with known deep vein thrombosis\u002Fpulmonary embolism that are under appropriate anti-coagulation treatment are eligible\n16. History of clinically significant hemoptysis within 1 month prior to study enrollment for any tumor type.\n17. Current, non-healing wound, ulcer or bone fractures\n18. Known hypersensitivity to defactinib, avutometinib, everolimus, and\u002For other rapamycin derivatives.\n19. Current warfarin use. Participants who are being treated with warfarin within 7-14 days prior to enrollment for deep vein thrombosis\u002Fpulmonary embolism may be eligible if their warfarin therapy can be converted to low molecular weight heparin or direct oral anticoagulants (DOACs). Participants who can be transitioned should have INR checked after 5 days on low molecular weight heparin or a direct oral anticoagulant (DOAC).\n\n    Participants are eligible if the INR is ≤ 1.5 prior to the first study dose.\n20. Current use of medications (with or without prescriptions), supplements, herbal remedies, or foods (Grapefruit and grapefruit juice, Seville oranges and star fruit) with potential for drug-drug interactions with avutometinib and\u002For defactinib within 5 half-lives (if known), or if not known then 14 days prior to the first dose of study intervention, including:\n\n    * Strong CYP3A4 inhibitors or inducers\n    * Strong CYP2C9 inhibitors or inducers\n    * Strong P-glycoprotein (P-gp) inhibitors or inducers\n    * Strong breast cancer resistance protein (BCRP) inhibitors or inducers\n21. Specific concurrent ocular disorders:\n\n    * History of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes\n    * History of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mmHg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n    * Active or chronic, visually significant corneal disorders, other active ocular conditions requiring ongoing therapy, or clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy. Examples of visually significant corneal disorders include corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions. Visually significant corneal disorders do NOT include dry eyes, blepharitis, and uncomplicated corneal erosions.\n22. Severe skin disorder in the opinion of treating MD that has required systemic therapy within one year of the first dose of study intervention.","FEMALE",{"count":192,"type":20},31,[49],"To find the recommended dose of the combination of avutometinib, defactinib, and everolimus in patients with endometrial cancer that is recurrent and has abnormal RAS activity. The safety and effects of this combination will also be studied.",[196,197,198,199],"Phase IB","Avutometinib","RAS Pathway","Endometrial",{"date":97,"type":31},{"date":202,"type":31},"2026-05-13",{"date":204,"type":20},"2030-08-01",{"name":37,"class":38},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100547763","phase-1-a-multicenter-phase-1b2-study-of-adagrasib-cetuximab-and-cemiplimab-for-metastatic-colorectal-cancer-harboring-kras-g12c-mutations-100547763","NCT06412198","A Multicenter Phase 1b\u002F2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of advanced\u002Fmetastatic microsatellite stable colorectal cancer with KRASG12C mutation with 1+ prior line(s) of therapy\n* Confirmed KRASG12C mutation status. If a molecular profiling report is not available, a representative paraffin-embedded tumor block or a minimum of 10 unstained slides will be requested for retrospective KRASG12C mutation testing.\n* Unresectable or metastatic disease.\n* Participants must have received at least one prior line of chemotherapy for metastatic disease with progression on treatment or intolerance to therapy.\n* Presence of measurable disease per RECIST 1.1\n* Willingness to participate in on-study related procedures, including mandatory biopsies (one baseline and one on-treatment biopsy).\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of the proposed combination in patients \\\u003C18 years of age, children are excluded from this study.\n* Able to take oral medications.\n* Most recent prior systemic therapy (e.g., chemotherapy, immunotherapy or investigational agent) and radiation therapy discontinued at least 7 days before first dose.\n* Recovery from the treatment-related adverse effects of prior therapy at the time of enrollment to ≤ Grade 1 (excluding alopecia and prior oxaliplatin-induced neuropathy).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values within the screening period:\n\n  * Absolute neutrophil count ≥ 1,000\u002Fmm3 (≥ 1.0 x 109\u002FL)\n  * Platelet count ≥ 100,000\u002Fmm3 (≥ 100 x 109\u002FL)\n  * Hemoglobin ≥ 9 g\u002FdL, in the absence of transfusions for at least 2 weeks\n  * Total bilirubin ≤ 1.5x upper limit of normal (ULN) (if associated with Gilbert's disease or UGT1A1\\*28 homozygosity, ≤ 3x ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0x ULN (if associated with liver metastases ≤5x ULN)\n  * Calculated creatinine clearance (determined as per Cockcroft-Gault) ≥ 60mL\u002Fmin at screening\n* Completed informed consent process, including signing of IRB-approved informed consent form.\n* Willing and able to comply with clinical trial instructions and requirements. Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation.\n* Participants who are biologically capable of having children and sexually active must agree to use an acceptable method of contraception for the duration of the treatment period and for at least 6 months after the last dose of study treatment. The Investigator will counsel the patient on selection of contraception method and instruct the participant in its consistent and correct use. Examples of acceptable forms of contraception include:\n\n  * Oral, inserted, injected or implanted hormonal methods of contraception, provided it has been used for an adequate period of time to ensure effectiveness.\n  * Correctly placed copper containing intrauterine device (IUD).\n  * Male condom or female condom used WITH a spermicide.\n  * Male sterilization with confirmed absence of sperm in the post-vasectomy ejaculate.\n  * Bilateral tubal ligation or bilateral salpingectomy.\n* The Investigator will instruct the participant to call immediately if the selected birth control method is discontinued or if pregnancy is known or suspected.\n\n  * Note: Women are considered post-menopausal and\u002For not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 months ago. In case of any ambiguity, the reproductive status of the woman should be confirmed by hormone level assessment.\n\nExclusion Criteria:\n\n* Prior PD1 or CTLA4 inhibition therapy\n* Prior KRASG12C inhibition therapy\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Active brain metastases, unless adequately treated and participant is neurologically stable (except for residual symptoms of central nervous system treatment) for at least 2 weeks prior to enrollment without corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)\n* Ongoing need for a medication with any of the following characteristics that cannot be switched to alternative treatment within 10 days prior to study entry: known risk of QTc prolongation or Torsades de Pointes; substrate of CYP3A with a narrow therapeutic index; strong inducer or inhibitor of CYP3A and\u002For P-gp; strong inhibitor of BCRP; strong inhibitor or inducer of CYP2C19; and proton pump inhibitors.\n\nNote: one dose of propofol, midazolam, and\u002For fentanyl under a monitored setting during IR guided biopsies is allowed.\n\n* Pregnancy. Women of child-bearing potential must have a negative serum or urine pregnancy test during screening\n* Breast-feeding or planning to breast feed during the study or within 6 months after end of treatment.\n* Participants with symptomatic leptomeningeal disease.\n* Major surgery within 4 weeks of first dose of any study drug.\n* History of intestinal disease or major gastric surgery likely to alter absorption of study treatment, to be determined by the treating physician\n* Known human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B (HBV) or C (HCV) infection as tested in a CLIA certified lab using a positive HIV antibody test. For Hepatitis B and C, an antigen that is drawn and positive. Note that the following are permitted:\n* Participants treated for HIV with no detectable viral load on current regimen for at least 1 month prior to randomization;\n* Note: Please refer to exclusion criteria regarding drug-drug interactions of concomitant anti-HIV agents, and in particular CYP3A substrates.\n* Participants with prior HBV infections who are:\n* considered to have past or resolved HBV infection, defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of hepatitis B surface antigen \\[HBsAg\\]; or\n* considered to be in an inactive HBV carrier state, defined as HBsAg-positive with normal ALT, and HBV DNA \\\u003C 2,000 IU\u002FmL or \\\u003C 10,000 copies\u002FmL;\n* Note: For participants in an inactive HBV carrier state or with a resolved HBV infection, the risk of HBV reactivation should be considered and the need for anti-HBV prophylaxis prior to randomization should be carefully assessed in accordance with local guidelines.\n* Participants treated for HCV with no detectable viral load.\n* Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with the participant's participation in the study, or with the interpretation of results.",{"count":192,"type":20},[49,23],"To learn if the drug combination of adagrasib, cetuximab, and cemiplimab can help to control metastatic CRC with KRAS G12C mutations.",[216,217],"Metastatic Colorectal Cancer","KRAS G12C Mutations",{"date":136,"type":31},{"date":220,"type":31},"2024-08-28",{"date":222,"type":20},"2029-03-01",{"name":37,"class":38},2,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"100537147","phase-3-prostate-iq-parallel-randomized-study-of-personalized-apalutamide-treatment-and-evaluation-to-improve-quality-of-life-in-post-operative-radiation-with-androgen-axis-suppression-a-phase-iii-multi-center-study-for-men-with-detectable-psa-after-prostatectomy-for-prostate-cancer-100537147","NCT06274047","PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.","Inclusion Criteria:\n\n1. Histologically confirmed prostate cancer.\n2. PSA ≥ 0.1 after radical prostatectomy.\n3. Candidate for salvage radiation and ADT treatment, as determined by treating physician.\n4. Age \\>18 at the time of consent.\n5. ECOG Performance Status ≤ 2.\n6. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 90 days of registration.\n\n   System Laboratory Value\n\n   Hematological:\n\n   Platelet count (plt) = ≥ 100,000\u002FµL\n\n   Hemoglobin (Hgb) = ≥ 9 g\u002FdL\n\n   Renal:\n\n   eGFR = ≥ 30 mL\u002Fmin using MDRD Formula\n\n   Hepatic and Other:\n\n   Bilirubin2 = ≤1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) = ≤ 2.5 x ULN Alanine aminotransferase (ALT) = ≤ 2.5 x ULN Serum Albumin = \\> 3.0 g\u002FdL Serum potassium = ≥ 3.5 mmol\u002FL 2In subjects with Gilbert's syndrome, if total bilirubin is \\>1.5 x ULN, measure direct and indirect bilirubin; if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible.\n7. Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee.\n8. Ability to understand English or Spanish language as determined by the site investigator or protocol designee. Since the primary outcome is a questionnaire available in English and Spanish.\n9. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Participants must have the ability to understand and willingness to sign the written informed consent document.\n\nExclusion Criteria:\n\n1. Use of post-prostatectomy testosterone suppression prior to registration (use of GnRH agonist or antagonist, with or without an anti-androgen). However, participants with testosterone recovery after post-prostatectomy testosterone suppression are eligible (testosterone recovery defined as total testosterone \\> 190 ng\u002FdL) regardless of how long their testosterone was suppressed.\n2. Use of testosterone suppression prior to prostatectomy if the ArteraAI Prostate Test (Post-RP) is required to risk stratify patients (those patients with PSA ≤0.5 and no evidence of nodal involvement require ArteraAI Prostate Test (Post-RP) to stratify).\n3. Confirmed extrapelvic or bone disease based on conventional imaging\n4. History of any of the following:\n\n   * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy).\n   * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization. Any condition that in the opinion of the investigator, would preclude participation in this study.\n5. Current evidence of any of the following:\n\n   * Uncontrolled hypertension (consistently \\>160 systolic or \\>100 diastolic)\n   * Gastrointestinal disorder affecting absorption\n   * Active infection (eg, human immunodeficiency virus \\[HIV\\] or viral hepatitis).\n   * Any condition that in the opinion of the investigator, would preclude participation in this study.\n6. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n8\\) Medications known to lower the seizure threshold (listed in section 5 below) must be discontinued or substituted 4 weeks prior to C1D1 of study treatment for participants on arms receiving apalutamide.",{"count":232,"type":20},120,[234],"PHASE3","1. Personalize treatment for prostate cancer based on how aggressive the disease is and\n2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.",[237,238,74],"Androgen Axis Suppression","Prostatectomy",[240,241,242,243],"Prostate","Salvage Radiation","ADT","Quality of Life",{"date":136,"type":31},{"date":246,"type":31},"2024-09-10",{"date":248,"type":20},"2029-06-30",{"name":37,"class":38},5,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":190,"minAge":17,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},"100461346","risk-reducing-salpingectomy-with-delayed-oophorectomy-as-an-alternative-to-risk--reducing-salpingo-oophorectomy-in-high-risk-women-to-assess-the-safety-of-prevention---us-cohort-study-100461346","NCT05287451","Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. Premenopausal women with a documented deleterious mutation in BRCA1, BRCA2, BRIP1, RAD51C, PALB2 and\u002For RAD51D gene germline mutation.\n2. Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2 and 30-50 years for BRIP1, RAD51C, RAD51D, and PALB2.\n\n   * The highest risk for cancer is mediated by the BRCA mutation. If a patient has multiple mutations, eligibility will be based on BRCA mutation.\n3. No longer requires fallopian tubes for natural childbearing. Future plans for IVF are acceptable.\n4. Presence of at least one fallopian tube.\n5. Participants may have a personal history of non-ovarian malignancy.\n6. Informed consent must be obtained and documented.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n1. Postmenopausal status (natural menopause or due to (cancer) treatment)\n\n   * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n   * A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation per the local standard of care can be considered.\n2. Wish for second stage RRO within two years after RRS (if clear at enrollment)\n3. Legally incapable\n4. Prior bilateral salpingectomy\n5. A personal history of ovarian, fallopian tube, or peritoneal cancer\n6. Current clinicals signs, diagnosis, or treatment for malignant disease. Aromatase Inhibitors, Tamoxifen, and Selective Estrogen Receptor Modulators (SERM) are allowed.",{"count":258,"type":20},100,[169],"This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence",[262,263],"Ovarian Cancer","Fallopian Tube Cancer",{"date":136,"type":31},{"date":266,"type":31},"2022-05-10",{"date":268,"type":20},"2026-12-26",{"name":37,"class":38},9,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":21,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":39},"100374101","phase-1-high-dose-steroid-therapy-prednisone-or-methylprednisolone-for-the-improvement-of-symptoms-of-late-radiation-associated-lower-cranial-neuropathy-in-oropharyngeal-cancer-survivors-100374101","NCT04151082","High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors","Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I\u002FII Dose Finding Trial and Data Registry","Inclusion Criteria:\n\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Disease free adult survivors of oropharyngeal cancer\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Treated with radiotherapy \\>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Late radiation-associated lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and\u002For biopsy fail to demonstrate structural or malignant source)\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Willing and able to return for assessment post-steroid therapy\n* INCLUSION CRITERIA FOR CLINICAL TRIAL: Able to complete symptom survey (MD Anderson Symptom Inventory - Head and Neck \\[MDASI-HN\\]) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese\n* INCLUSION CRITERIA FOR REGISTRY: Disease-free adult survivors of head and neck cancer\n* INCLUSION CRITERIA FOR REGISTRY: \\>= 2 years post treatment (disease status per surveillance imaging and clinical surveillance)\n* INCLUSION CRITERIA FOR REGISTRY: Late lower cranial neuropathy of XII with or without X nerve (LCNP cases will be considered therapy-related when imaging, physical examination, and\u002For biopsy fail to demonstrate structural or malignant source)\n* INCLUSION CRITERIA FOR REGISTRY: Able to complete symptom survey (MDASI-HN) in validated languages: English, simplified Chinese, Filipino, Greek, Japanese, Korean, Russian, Spanish, Taiwanese\n\nExclusion Criteria:\n\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled diabetes\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Uncontrolled hypertension (systolic \\> 160; diastolic \\> 90)\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known gastrointestinal ulcer\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of psychosis\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Pregnant women\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Untreated or treatment refractory obstructive pharyngoesophageal stricture\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: Known history or diagnosis of bipolar disorder\n* EXCLUSION CRITERIA FOR CLINICAL TRIAL: History of surgery near hypoglossal nerve path\n* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled diabetes\n* EXCLUSION CRITERIA FOR REGISTRY: Uncontrolled hypertension (systolic \\> 160; diastolic \\> 90)\n* EXCLUSION CRITERIA FOR REGISTRY: Known gastrointestinal ulcer\n* EXCLUSION CRITERIA FOR REGISTRY: History of psychosis\n* EXCLUSION CRITERIA FOR REGISTRY: Pregnant women\n* EXCLUSION CRITERIA FOR REGISTRY: Untreated or treatment refractory obstructive pharyngoesophageal stricture\n* EXCLUSION CRITERIA FOR REGISTRY: Known history or diagnosis of bipolar disorder",{"count":279,"type":20},35,[49,23],"This phase I\u002FII trial studies the side effect and best dose of steroid therapy (prednisone or methylprednisolone) in improving symptoms of late radiation-associated lower cranial neuropathy in oropharyngeal cancer survivors. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy.",[283,284,285],"Cranial Nerve Disorder","Head and Neck Carcinoma","Oropharyngeal Carcinoma",{"date":136,"type":31},{"date":288,"type":31},"2019-10-16",{"date":290,"type":20},"2027-07-31",{"name":37,"class":38},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":68,"minAge":17,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":39},"100637127","efforts-to-increase-representation-in-prostate-cancer-clinical-trials-at-lyndon-b-johnson-hospital-100637127","NCT07591701","Efforts to Increase Representation in Prostate Cancer Clinical Trials at Lyndon B. Johnson Hospital","Inclusion Criteria:\n\nThese criteria include diagnosed prostate cancer patients receiving care at LBJ Hospital who\n\nAre eligible for an open prostate cancer clinical trial at LBJ Hospital during the study period\n\nCan provide informed consent.\n\nExclusion Criteria:\n\nThese criteria include prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition or have a medical condition that prevents participation in the trial.",{"count":299,"type":20},60,[169],"The main rationale underlying this study is that prostate cancer clinical trials are lacking representation from racial and ethnic minority groups. Study proposal aims to target barriers at the participant, investigator, and health system level through specific interventions to increase the percentage of participants from these backgrounds on cancer clinical trials.",[74],"2026-06-23",{"date":136,"type":31},{"date":306,"type":31},"2026-05-26",{"date":308,"type":20},"2030-01-31",{"name":37,"class":38},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":39},"100627130","phase-1-phase1-basket-trial-of-car70-engineered-il15-transduced-with-tgfbr2-knock-out-cord-blood-derived-nk-cells-for-relapsedrefractory-lymphoid-malignancies-100627130","NCT07444632","Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed\u002FRefractory Lymphoid Malignancies","Inclusion Criteria:\n\n1. 18-75 years of age.\n2. Diagnosis of relapsed B-NHL, HL, T-NHL, or B-ALL in refractory relapse, defined as:\n\n   * B-NHL: Failure of \\>\u002F= 1 salvage line and failure of or ineligibility for CAR-T.\n   * HL and T-NHL: Failure of \\>\u002F= 1 salvage line or prior SCT.\n   * ALL: Active disease (\\>5% of blasts or positive MRD at a level of \\>0.1% measured by multiparameter flow cytometry) after ≥ 2 two lines of therapy. Patients with B-ALL must have either failed of or be ineligible for CAR-T cell therapy. Patients who have mutations for which there are FDA approved targeted therapies (i.e., BCR-ABL) must also have received at least one of such agents.\n3. Expression of CD70 in the pre-enrollment sample \\>\u002F= 20% measured by immunohistochemistry or flow cytometry.\n4. Measurable disease, defined by \\>\u002F= 1 histologically confirmed hypermetabolic lesion on PET\u002FCT scan.\n5. ECOG PS ≤ 2 (Karnofsky ≥60%).\n6. Adequate blood counts (WBC \\>\u002F= 2K, HGB \\>\u002F= 8 g\u002FdL, platelets \\>\u002F= 50K).\n7. Creatinine clearance ≥ 30 ml\u002Fmin.\n8. ALT and\u002For AST ≤ 3 x ULN, and bilirubin and ALP ≤ 2 x ULN.\n9. FEV1, FVC and DLCOc ≥ 50%.\n10. LVEF ≥ 40%, without active arrythmias.\n11. If female of child-bearing potential, she must not be pregnant or breastfeeding and required to have a negative urine or serum pregnancy test prior to enrollment.\n12. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n13. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection still on treatment, they are eligible if they have an undetectable HCV viral load.\n14. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n15. Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n16. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n17. The effects of CAR-NK cells on the developing human fetus are unknown. For this reason and because fludarabine and cyclophosphamide, as well as other therapeutic agents, used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence, see Appendix 1) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114).\n\n    * This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received whole pelvic radiation therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n    * Approved methods of birth control (see Appendix 1) are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide.\n\n    Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n    • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CAR NK cell administration.\n18. Ability to understand and willingness to sign a written informed document.\n19. Agree to sign consent to the long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies.\n\nExclusion Criteria:\n\n1. Lymphoma or ALL in CR with no measurable sites of disease.\n2. Major surgery \\\u003C4 weeks prior to first dose of study drug.\n3. Any other severe or uncontrolled disease or condition which mightincrease the risk associated with study participation.\n4. Any other malignancy known to be active, with the exception of treated cervical intraepithelial neoplasia and non-melanoma skincancer.\n5. Grade \\>\u002F= 3 non-hematologic toxicity from prior therapy that has notimproved to grade \\\u003C\u002F= 2.\n6. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \\>\u002F=10,000 copies\u002FmL, or \\>\u002F=2,000 IU\u002FmL), or hepatitis C (detectable viral load by HCV RNA PCR).\n7. Active infection requiring parenteral antibiotics.\n8. HIV infection.\n9. Treatment within prior 2 weeks with any anti-cancer agent,investigational or approved.\n10. Active CNS involvement (untreatedparenchymal brain metastasis or positive cytology of cerebrospinal fluid).\n11. Life expectancy \\\u003C\u002F= 6 months.\n12. Active and uncontrolled neurological disorder.\n13. Patients receiving systemic steroid therapy at time of enrollment (physiological replacement doses are allowed) or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.\n14. Patients receiving immunosuppressive therapy.\n15. Patients who are receiving any other investigational agents.\n16. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","75 Years",{"count":299,"type":20},[49],"This is a phase 1 basket trial of TGFBR2 KO CAR27\u002FIL-15 NK cells after lymphodepleting chemotherapy for patients with R\u002FR B-NHL, HL, T-NHL or B-ALL.",[321,322],"Lymphoid","Hodgkin Lymphoma",{"date":136,"type":31},{"date":325,"type":31},"2026-05-28",{"date":327,"type":20},"2032-09-30",{"name":37,"class":38},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":39},"100624306","phase-2-ph2-study-for-optimization-of-adjunct-systemic-therapy-in-her2-patients-molecularpcr-trial-100624306","NCT07407920","Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial","Optimization of Adjuvant Systemic Therapy in Patients With Early HER2-Positive (HER2+) Breast Cancer or Triple Negative Breast Cancer (TNBC) That Achieved a Pathological Complete Response (pCR) After Neoadjuvant Systemic Therapy and Do Not Have Molecular Residual Disease (MRD-Negative): A Phase II Clinical Trial (The MolecularPCR Trial)","Inclusion Criteria:\n\n* EARLY HER2 POSITIVE (+) BREAST CANCER COHORT: Female or male with a diagnosis of biopsy proven invasive breast cancer HER2+, hormone (estrogen and progesterone)-receptor positive or negative. The HER2 status (following American Society of Clinical Oncology \\[ASCO\\]\u002FCollege of American Pathologists \\[CAP\\] guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines\n* EARLY TNBC COHORT: Female or male with a diagnosis of biopsy proven invasive TNBC (estrogen and progesterone receptor \\\u003C 10%). The HER2 status (following ASCO\u002FCAP guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines\n* FOR BOTH HER2+ AND TNBC COHORTS: Invasive breast cancer of any tumor histologic grade and\u002For nuclear grade, and any tumor histological subtype including but not limited to infiltrating ductal carcinoma, infiltrating lobular carcinoma, mucinous carcinoma, papillary carcinoma, tubular carcinoma, metaplastic carcinoma, and mixed histology\n* FOR BOTH HER2+ AND TNBC COHORTS: Clinical tumor stage (per American Joint Committee on Cancer \\[AJCC\\] 8th edition): T1-4, N0-2a, M0. Patients who have a diagnosis of inflammatory breast cancer are eligible. Patients should not have clinical evidence of locoregional or distant metastatic breast cancer\n* EARLY HER2+ BREAST CANCER COHORT: Have completed NST with a trastuzumab plus pertuzumab and chemotherapy-based regimen (for example, docetaxel plus minus carboplatin plus trastuzumab plus pertuzumab known as the docetaxel\u002Fpertuzumab\u002Ftrastuzumab \\[THP\\]\u002Fcarboplatin\u002Fpaclitaxel\u002Fpertuzumab\u002Ftrastuzumab \\[TCHP\\] regimens) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant trastuzumab plus pertuzumab\n* EARLY TNBC COHORT: Have completed NST with a pembrolizumab plus chemotherapy-based regimen (for example, the KEYNOTE-522 regimen which is paclitaxel plus carboplatin plus pembrolizumab followed by doxorubicin plus cyclophosphamide plus pembrolizumab) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant pembrolizumab\n* The surgical pathology report needs to show a pCR (ypT0-Tis, ypN0) for a patient to be able to participate in this study and all enrolled patients should be willing to discontinue standard adjuvant systemic therapy\n* FOR BOTH HER2+ AND TNBC COHORTS: Adequate archival tumor tissue from the core diagnostic biopsy (per Personalis)\n* FOR BOTH HER2+ AND TNBC COHORTS: Age ≥ 18 years\n* FOR BOTH HER2+ AND TNBC COHORTS: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* FOR BOTH HER2+ AND TNBC COHORTS: Absolute neutrophil count ≥ 1,000\u002FmcL\n* FOR BOTH HER2+ AND TNBC COHORTS: Hemoglobin ≥ 9.0 g\u002FdL\n* FOR BOTH HER2+ AND TNBC COHORTS: Platelets ≥ 100,000\u002FmcL\n* FOR BOTH HER2+ AND TNBC COHORTS: Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN); patients with Gilbert's syndrome (if direct bilirubin \\\u003C1.5 x institutional ULN)\n* FOR BOTH HER2+ AND TNBC COHORTS: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* FOR BOTH HER2+ AND TNBC COHORTS: Creatinine ≤ 1.5 mg\u002FdL\n* FOR BOTH HER2+ AND TNBC COHORTS: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* FOR BOTH HER2+ AND TNBC COHORTS: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* FOR BOTH HER2+ AND TNBC COHORTS: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible\n* FOR BOTH HER2+ AND TNBC COHORTS: Pre- and postmenopausal women are eligible\n* FOR BOTH HER2+ AND TNBC COHORTS: Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients with tumor stage of cN2b or cN3 are not eligible\n* History of other malignancies besides breast cancer within the past 5 years, except cervical cancer in situ, melanoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin\n* Patients who are receiving any other anti-cancer investigational agents\n* Patients with known cancer metastases from any site\n* Patients with uncontrolled intercurrent illness including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrythmias\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Blood transfusion within 2 weeks before collection of blood for ctDNA testing\n* Patients who have received 4 or more cycles of SOC adjuvant trastuzumab\u002Fpertuzumab (HER2+) or 4 or more cycles of SOC adjuvant pembrolizumab (TNBC)\n* Pregnant women are not eligible to participate in this study",{"count":232,"type":20},[23],"This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular residual disease) circulating in their blood. Standard of care treatment after surgery consists of 1 year of pembrolizumab for patients with triple negative breast cancer or trastuzumab with or without pertuzumab to complete 1 year of treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Lowering the total amount of cancer therapy after breast surgery, may continue to keep the great tumor response to treatment, and may help lower the amount of side effects patients have.",[340,341,342,343],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Early Stage HER2-Positive Breast Carcinoma","Early Stage Triple-Negative Breast Carcinoma",{"date":177,"type":31},{"date":346,"type":31},"2025-10-09",{"date":348,"type":20},"2027-09-30",{"name":37,"class":38},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":21,"phases":357,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":39},"100573325","early-phase-1-exploring-the-benefit-of-topical-capsaicin-in-treating-pain-from-chemo-induced-peripheral-neuropathy-a-longitudinal-single-center-pilot-study-100573325","NCT06744816","Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study","Inclusion Criteria:\n\n* Participants diagnosed with pain of the lower extremity from chronic (\\>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center\n* Participants reporting baseline pain ≥ 4 (0-10 scale, NRS)\n* Participants age 18+\n* Participants who have completed chemotherapy within the last year at the time of enrollment.\n\nExclusion Criteria:\n\n* Participants with cognitive dysfunction\n* Participants with recent history (\\\u003C6 months) of drug or alcohol abuse\n* Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection\n* Participants with allergies to capsaicin or adhesives\n* Pregnant participants",{"count":19,"type":20},[358],"EARLY_PHASE1","To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.",[361],"Peripheral Neuropathy Due to Chemotherapy",{"date":136,"type":31},{"date":364,"type":31},"2025-12-11",{"date":366,"type":20},"2027-11-30",{"name":37,"class":38},{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":376,"phases":4,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":384,"locationsCount":39},"100512635","data-collection-protocol-for-patients-with-von-hippel-lindau-disease-100512635","NCT05955014","Data Collection Protocol for Patients With Von Hippel Lindau Disease","Inclusion Criteria:\n\n* Presence of genetic confirmation or clinical criteria consistent with vHL disease.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n• Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":375,"type":20},125,"OBSERVATIONAL","To collect information from patients with vHL disease. Information collected will include data on the status of the disease, any surgeries or therapies patients have received for vHL disease, and quality of life.",[379],"Von Hippel Lindau Disease",{"date":136,"type":31},{"date":382,"type":31},"2023-08-24",{"date":139,"type":20},{"name":37,"class":38},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":39},"100610463","phase-2-neuroguard-psilocybin-trial-for-preventing-chemo-induced-neuropathy-100610463","NCT07227909","NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy","Eligibility Criteria\n\n1. Participants with histologically or cytologically confirmed breast, colorectal, or head and neck cancer.\n2. Scheduled to receive platinum-based chemotherapy or taxanes (e.g., paclitaxel, docetaxel).\n3. Age 18 years or older\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n5. No pre-existing peripheral neuropathy greater than Grade 1 as defined by the NCI-CTCAE v5.0.\n6. No prior grade 3 AEs on current standard of care cancer treatment regimen\n7. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).\n8. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.\n9. Agree to abstain from any nicotine products for at least 8-12 hours prior to psilocybin administration until approximately 12 hours after (or when all post-session questionnaires have been completed, whichever comes earlier).\n10. Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions and must refrain from psychoactive drugs 12 hours after psilocybin sessions. Must consent to urine drug screen (UDS) which will be given before receiving psilocybin. Participants with positive drug test will be retested (UDS) after 6 weeks and included if the repeated UDS is negative. Participant tested positive for a prescribed substance are eligible. Participant failing on the 2nd test (UDS) will be excluded.\n11. Must be free from any regularly scheduled psychotropic (antidepressant\u002Fanxiolytic class) medications for a minimum of 2 weeks prior to study. Intermittent or PRN use of short-acting anxiolytics or and anti-nausea medications (e.g., ondansetron) may be permitted as defined below in exclusionary criteria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n12. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.\n13. Eligible subjects will have a third-party transportation by a licensed driver (e.g. friend, family or a driver) after the psilocybin session is complete. If a driver is used, a friend or family member must accompany them in the vehicle home\n14. Participants should agree to refrain from driving, operating heavy machinery, or engaging in safety-sensitive activities for the remainder of the day following psilocybin administration (for both 25mg or subperceptual 1mg placebo).\n15. Fluent in English\n\nExclusion Criteria\n\n1. History of another primary malignancy, except for:\n\n   1. Malignancy treated with curative intent and no active disease for ≥ 5 years before the first dose of study drug, with low potential risk for recurrence.\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   3. Adequately treated carcinoma in situ without evidence of disease.\n2. Clinically significant suicidality or high risk of completed suicide defined as:\n\n   1. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline\n   2. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts\n   3. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self- injurious behavior\n3. History of bipolar disorder, psychosis (including a history of schizophrenia).\n4. Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional.\n5. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.\n6. ECG with QTc \\> 450.\n7. Participants with non-MRI compatible metal implants.\n8. Asymptomatic ALT or AST elevations \\>\u002F= 5X upper limit of normal, symptomatic ALT or AST elevations \\>\u002F= 2X upper limit of normal, or total bilirubin \\>\u002F= 2X upper limit of normal.\n9. Uncontrolled diabetes Mellitus with hemoglobin A1c \\> 8.5%\n10. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstaining from intercourse with the opposite sex) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n11. Vulnerable populations, including children and cognitively impaired participants, will not be enrolled in this study.\n12. Participants with brain metastases.\n13. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (day of dosing, prior to dosing) blood pressure \\>180\u002F120mmHG, HR \\>110 bpm. Of note, we will repeat vital signs for subjects with high initial reading and average three readings to determine eligibility criteria in such cases to account for normal variability in vital sign and \"white coat hypertension.\"\n14. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial.\n\n    Some examples include:\n    1. Uncompensated congestive heart failure\n    2. Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450)\n    3. Recent acute myocardial infarction or evidence of ischemia\n    4. Malignant hypertension\n    5. Congenital long QT syndrome\n    6. Acute renal failure\n    7. Severe hepatic impairment\n    8. Respiratory failure\n15. Significant central nervous system (CNS) pathology. Some examples include:\n\n    1. Primary or secondary cerebral neoplasm on imaging\n    2. Epilepsy and any history of seizure (regardless of if related to epilepsy) except for a onetime febrile seizure in childhood\n    3. History of stroke in the past 3 years\n    4. Untreated cerebral aneurysm\n    5. Dementia\n    6. Ongoing delirium of any kind (including with or without psychosis) in which subjects would not have the capacity to participate in the study.\n16. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation.\n\n    Examples include:\n    1. Agitation\n    2. Violent behavior\n17. Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year\n\n    a. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. \\>22 lifetime uses iii. History of diagnosed hallucinogen persisting perception disorder (HPPD)\n18. Concurrent Medications\n\n    1. Antidepressants\n    2. Centrally-acting serotonergic agents (e.g., MAO inhibitors)\n    3. Antipsychotics (e.g., first and second generation)\n    4. Mood stabilizers (e.g., lithium, valproic acid)\n    5. Aldehyde dehydrogenase inhibitors (e.g., disulfiram)\n    6. Significant inhibitors of UGT 1A0 or UGT 1A10\n    7. serotonin-acting dietary supplements (such as 5-hydroxytryptophan or St. John's wort)\n    8. efavirenz\n    9. Other Medications Listed in Section 3.1 19. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\n    \u003C!-- -->\n\n    1. Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n    2. Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n    3. Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n    4. Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use 72 hours prior to dosing and until 12 hours after dosing.\n\n20\\. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin\n\n1. Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n2. Have an allergy or intolerance to any of the materials contained in either drug product Be enrolled in another clinical trial assessing intervention(s) for prevention or treatment of any pain-related symptoms",{"count":392,"type":20},83,[23],"To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo.",[396,397],"Psilocybin","Neuropathy","2026-06-22",{"date":177,"type":31},{"date":401,"type":20},"2026-11-04",{"date":403,"type":20},"2031-01-31",{"name":37,"class":38},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":21,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":39},"100612706","checkpoint-inhibitor-associated-diabetes-mellitus-early-recognition-and-treatment-cert-project-a-pilot-study-100612706","NCT07257068","Checkpoint Inhibitor Associated Diabetes Mellitus: Early Recognition and Treatment (CERT) Project: A Pilot Study","Eligibility Criteria\n\n* Participants on ICI referred to endocrine for new diagnosis of CIADM, will be included provided they are within 12 months of last dose of ICI and if they have:\n\n  * New onset diabetes≥ 200 mg\u002Fdl and\u002For A1c ≥6.5 OR\n  * Worsening glycemic control: requiring insulin per clinician assessment (fasting glucose or average glucose on CGM\\>20% and \u002For A1c \\>0.5% from prior to ICI use ) AND \u002FOR\n  * If Presenting with DKA\u002FHHS: include if within 6 weeks of presentation AND\n  * Must have detectable random c-peptide level 0.2 - 1 ng\u002FmL with blood glucose of 145 mg\u002Fdl\n* Age ≥18 years. Because adverse event data are currently available on the use of infliximab in combination within participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤2 (Karnofsky ≥60%,).\n* Participants must have adequate organ and marrow function as defined below:\n\nabsolute neutrophil count ≥1,000\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN\n\nCardiac ejection fraction \\> 50%\n\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of infliximab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Participants already on insulin for pre-existing type 1 or type 2 diabetes.\n* Participants with undetectable c-peptide levels i.e. \\\u003C0.2 with blood glucose of 145 mg\u002Fdl or higher.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with a h\u002Fo active TB or latent TB will be excluded.\n* Participants with known history of any NYHA class heart failure or ejection fraction \\\u003C50% will be excluded.\n* Participants requiring supraphysiological doses of steroids i.e. prednisone \\>10mg of equivalent at the time of study entry, will be excluded\n* Participants who have ICI hepatitis and myocarditis will be excluded\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities ≥ Grade 2) with the exception of alopecia.\n* Participants who are receiving any other investigational agents for CIADM.\n* History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to Infliximab or other agents used in study.\n* Required: any concomitant drugs used as defined in section 5.7 will be excluded.\n* Participants with uncontrolled intercurrent illness: active infection\u002F sepsis\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant and breastfeeding women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with infliximab. Breastfeeding should be discontinued if the mother is treated with infliximab. These potential risks may also apply to other agents used in this study",{"count":412,"type":20},14,[169],"To find out if taking a drug called infliximab (the \"study drug\") is safe and effective in reversing insulin dependence in CIADM.",[416,417,418],"Checkpoint Inhibitor","Pilot Study","Diabetes Melletus",{"date":303,"type":31},{"date":421,"type":20},"2026-09-14",{"date":423,"type":20},"2029-12-31",{"name":37,"class":38},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":21,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":39},"100614749","phase-1-a-phase-ib-trial-of-subcutaneous-blinatumomab-in-combination-with-revumenib-for-patients-with-kmt2a-rearranged-acute-lymphoblastic-leukemia-100614749","NCT07283640","A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia","Eligibility Criteria\n\n• The following groups of participants will be eligible:\n\n* Participants \\> 18 years of age with relapsed and\u002For refractory (defined as \\>5% blasts in the peripheral blood or bone marrow) KMT2A-r B-cell ALL or\n* Participants \\>18 years of age with persistent measurable residual disease by flow cytometry or next generation sequencing KMT2A-r B-cell ALL or\n* Newly diagnosed participants with KMT2A-r B-cell ALL \\> 60 years old or unfit for intensive chemotherapy\n\nUnfit for intensive chemotherapy defined as:\n\n* ECOG \\>2\n* Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction \\\u003C50%, or chronic stable angina)\n* Severe pulmonary disorder (e.g., DLCO \\\u003C65% or FEV1 \\\u003C65%)\n* Creatinine clearance \\\u003C45 ml\u002Fmin\n* Hepatic disorder with total bilirubin 1.5 x upper limit of normal\n* Performance status \\\u003C2 per ECOG scale (for R\u002FR participants)\n* Adequate liver function as defined by the following criteria:\n\n  * Total serum bilirubin \\\u003C1.5 x upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN\n* Adequate pancreatic function as define by serum lipase and amylase \\\u003C 1.5 x ULN\n* For females of childbearing potential, a negative pregnancy test must be documented (negative serum pregnancy test performed at the time of screening and negative serum or urine pregnancy test prior to the first dose of study drug)\n* The effects of blinatumomab and revumenib on the developing human fetus are unknown. For this reason and because menin inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of blinatumomab and revumenib administration. Males must also agree to refrain from sperm donation during this time period.\n* Adequate cardiac function as assessed clinically by history and physical examination with an ejection fraction of \\>50% by echocardiogram or multigated acquisition (MUGA) scan\n* White blood cell (WBC) count below 25,000\u002FuL at the time of enrollment. Participants may receive cytoreduction with dexamethasone and\u002For cyclophosphamide for cytoreduction\n* Estimated glomerular filtration rate (GFR) based on local institutional practice for age appropriate determination by Cockcroft Gault formular for adults, with a GFR\\>60 ml\u002Fmin\u002F1.73m2\n* For participants having previously received stem cell transplant, at least 60 days must have elapsed, and for prior donor lymphocyte infusion, at least 4 weeks must have elapsed\n* For participants having previously received immunotherapy, at least 60 days must have passed\n* Weight of at least 40 kg\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Active serious infection not controlled by oral or IV antibiotics\n* Active secondary malignancy other than skin cancer (basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year\n* Participants with psychiatric illness that would limit compliance with study requirements\n* Untreated CNS disease. Participants with controlled CNS disease may be included (as defined by being asymptomatic and having CNS cleared of leukemic involvement)\n* Detectable HIV viral load within the previous 6 months. Participants with a known history of HIV must have viral load testing prior to study enrollment.\n* Any of the following within 6 months prior to study entry: myocardial infarction, congestive heart failure New York Heart Association Classification Class \\> II, life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack\n* QTc using Friderica's correction (QTcF) \\>450 msec\n* Personal of family history of long QT syndrome\n* Cirrhosis with a Child Pugh score of B or C\n* Participants with active hepatitis B (defined as Hepatitis B surface antigen with detectable Hepatitis B virus DNA by PCR) or hepatitis C infection (defined as presence of detectable Hepatitis C virus RNA by PCR)",{"count":19,"type":20},[49],"To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed\u002Frefractory Ph-negative ALL with a KMT2A rearrangement.",[435,436,437,438],"Blinatumomab","Revumenib","Lymphoblastic Leukemia","KMT2A-rearranged",{"date":303,"type":31},{"date":441,"type":20},"2026-11-18",{"date":443,"type":20},"2031-08-31",{"name":37,"class":38},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":21,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":39},"100607822","phase-2-a-phase-2-trial-of-zanzalintinib-in-advancedmetastatic-bone-sarcomas-zambone-100607822","NCT07193550","A Phase 2 Trial of Zanzalintinib in Advanced\u002FMetastatic Bone Sarcomas (ZAMBONE)","Inclusion Criteria:\n\n• Patients ≥ 18 years old with pathologically confirmed unresectable locally advanced or metastatic bone sarcoma in one of the following categories: Cohort A - Osteosarcoma, Cohort B - Ewing sarcoma, Cohort C - Chondrosarcoma (conventional, grades 2-3), Cohort D - Other primary sarcoma of bone including but not limited to dedifferentiated chondrosarcoma, undifferentiated pleomorphic sarcoma (UPS) of bone, chordoma, and non-Ewing's round cell sarcomas of bone.\n\nchondrosarcoma, undifferentiated pleomorphic sarcoma (UPS) of bone, chordoma, and non-Ewing's round cell sarcomas of bone.\n\n* Patients with conventional chondrosarcoma (Cohort C) must demonstrate evidence of disease progression by RECIST 1.1 within 12 weeks of trial enrollment\n\n  * Patients must have relapsed or become refractory to conventional therapy, receiving at least 1 prior line of systemic therapy unless no standard of care exists.\n  * Patients may have received no more than 2 prior lines of systemic therapy in the advanced\u002Fmetastatic setting.\n* Multi-agent and\u002For alternating neoadjuvant\u002Fadjuvant standard of care chemotherapy will be counted as 1 line of systemic therapy if given for metastatic disease. Otherwise, neoadjuvant\u002Fadjuvant chemotherapy for localized disease does not apply towards the limitation regarding prior lines of systemic therapy.\n\n  * Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2 (Karnofsky ≥60%).\n  * Weight \\>\u002F= 40 kg.\n  * Patients must have measurable disease per RECIST v1.1\n  * Prior radiation will be allowed assuming there is measurable disease based upon RECIST 1.1 and at least 21 days from the completion of all radiation prior to initiation of study treatment. (Note: Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation)\n  * Hematological function, as follows:\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (growth factor\u002FG-CSF permitted)\n* Platelet count ≥ 100,000\u002Fmm3\n* Hemoglobin \\> 9 g\u002FdL.\n\n  * INR ≤ 1.5 and activated partial thromboplastin time (aPTT) \\\u003C 1.2 x upper limit of normal (ULN), except subjects on anticoagulation.\n  * Renal function as follows: calculated creatinine clearance ≥ 40 mL\u002Fmin (≥ 0.67 mL\u002Fsec) using the Cockcroft Gault equation.\n  * Hepatic function as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN and total bilirubin ≤ 1.5 x ULN (for subjects with Gilberts's disease ≤ 3 x ULN), serum albumin ≥ 2.\n  * All patients must agree to consent and co-enroll on MD Anderson MOSAIC protocol to allow for sample collection and correlative studies\n  * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n  * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n  * Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n  * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n  * Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating hormone \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n  * Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (hormonal or barrier method of birth control, intrauterine device, tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, implantable or injectable contraceptives, condoms, or abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\nIn addition, men must agree not to donate sperm through 96 days after the last dose of zanzalintinib and women (WOCBP) must agree not to donate effs (ova, oocyte) for the purpose of reproduction for at least 186 days after the last dose of zanalintinib.\n\n• Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nPrior treatment with zanzalintinib.\n\n* Patients with primary soft tissue sarcoma with metastasis to bone.\n\n  o Patients with histologically confirmed Ewing's sarcoma with either bone or soft tissue primary site are eligible for enrollment in Cohort B\n* Patients with known sensitivity to the study agents and\u002For previously identified allergy or hypersensitivity to components of treatment\n* Patients previously treated with other VEGF-targeted TKIs (including but not limited to cabozantinib, regorafenib, pazopanib, or similar).\n* Receipt of any small molecule kinase inhibitor (including investigational within 2 weeks before first dose of study treatment.\n* Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression.\n* Active infection requiring intravenous (IV) antibiotics within 2 weeks of study enrollment.\n* Prior receipt of an investigational study drug and\u002For procedure within 21 days of study day 1.\n* Anti-tumor therapy within 21 days of study day 1 including chemotherapy, antibody therapy, or other investigational agent.\n* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment; ongoing clinically relevant complications from prior radiation therapy are not eligible.\n* Any complementary medicine such as herbal supplements, Chinese medicines, or other non-prescription medications being used for the treatment of bone sarcoma within 2 weeks prior to first dose of treatment as detailed in section5.5.\n* History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class \\> II, unstable angina (angina symptoms at rest), new-onset angina (within the past 6 months before study entry), myocardial infarction within the past 6 months before study entry.\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment\n* Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C.\n* Patients with known human immunodeficiency virus (HIV) infection with detectable viral load.\n\nHIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\n* Known infection with acute or chronic hepatitis B or C.\n* History of solid organ or allogeneic stem cell transplant\n* Any other known concurrent or prior malignancy at time of or within 2 years of first does of study treatment. Prior malignancy that is in remission or otherwsie has not required treatment in \\> 2 years will be permitted.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.\n* Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment. Note, patients with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion) for at least 1 week before first dose of study treatment.\n* Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n  * Tumors invading the GI-tract from external viscera\n  * Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n  * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and asymptomatic\n  * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months of the first dose. Note, complete healing of an intra-abdomninal abscess must be confirmed before first dose of study treatment\n  * Known gastric or esophageal varices\n  * Ascites, pleural effusion, or pericardial effusion requiring drainage in last 4 weeks\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n* Symptomatic cavitating pulmonary lesion(s) or endobronchial disease. Note, asymptomatic or radiated lesions allowed\n* Lesions invading major blood vessel including but not limited to inferior vena cava, pulmonary artery, or aorta. Note, patients with intravascular tumor extension (i.e. tumor thrombus in renal vein or inferior vena cava) may be eligible following Principal Investigator approval\n* Other clinically significant disorders that would preclude safe study participation:\n\n  * Serious non-healing wound, ulcer, or bone fracture. Note, non-healing wounds or ulcers may be permitted if due to tumor associated skin lesions\n  * Malabsoprtion syndromes\n  * Pharmacologically uncompensated, symptomatic hypothyroidism\n  * Requirement for hemodialysis or peritoneal dialysis\n  * History of solid organ or allogeneic stem cell transplant\n* Major surgery (i.e. GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laproscopic surgeries withint 4 weeks prior to first dose of study treatment. Minor surgery (i.e. simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment. Note, fresh\u002Fpre-treatment tumor biopsies should be completed at least 5 days prior to the first dose of study treatment. Patients with clinically relevant ongoing complications of prior surgical procedures, including biopsies, are not eligible.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 470 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment. Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or lactating women are excluded from this study because zanzalintinib is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with zanzalintinib, breastfeeding should be discontinued if the mother is treated with zanzalintinib. These potential risks may also apply to other agents used in this study.\n* Inability to swallow tablets or ingest a suspension either orally or by nasogastric (NG) or gastronomy (PEG) tube.\n* Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors ) and platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.\n  * Note, Subjects must have discontinued prohibited oral anticoagulants at least 3 days or 5 half-lives prior to the first dose of study treatment, whichever is longer\n* Proteinuria \\> 1g\u002Fday.\n* Other conditions, which in the opinion of the investigator, would compromise the safety of the patient's ability to complete the study",{"count":452,"type":20},70,[23],"To study the treatment efficacy of zanzalintinib monotherapy in patients with advanced and\u002For metastatic bone sarcomas.",[456],"Bone Sarcomas",{"date":177,"type":31},{"date":459,"type":31},"2025-12-05",{"date":461,"type":20},"2031-10-31",{"name":37,"class":38},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":479,"locationsCount":39},"100600741","phase-1-phase-i-study-of-preconditioning-radiation-therapy-with-il-15-transduced-tgfbr2-ko-cartrop2-engineered-cord-blood-derived-nk-cells-in-patients-with-advanced-head-and-neck-cancer-radiance-nk-100600741","NCT07101432","Phase I Study of Preconditioning Radiation Therapy With IL-15 Transduced TGFBR2 KO CAR.TROP2-engineered Cord Blood-derived NK Cells in Patients With Advanced Head and Neck Cancer (RADIANCE-NK)","Inclusion Criteria:\n\nPatients with histologically confirmed head and neck cancer, either HPV+ or HPV-, that is locally advanced AND unresectable OR metastatic (≤5 sites of disease), which has relapsed or progressed following local standard treatments that are known to prolong survival, or for which no standard treatment is available or are no longer effective, or refused such therapy.\n\nPatient tumors must demonstrate TROP2 expression of 2+ or 3+ as determined by IHC at the MDACC CAP and CLIA accredited Clinical Laboratories.\n\n* 2 weeks from the last cytotoxic chemotherapy at the time of lymphodepleting chemotherapy; ≥3 days from last TKI or other targeted therapies at the time of lymphodepleting chemotherapy; ≥3 months from any cell therapy for any malignancy at the time of lymphodepleting chemotherapy; prior radiation therapy is allowed at the time of consent.\n\nRT allowed to ≥1 disease sites prior to the lymphodepleting chemotherapy. If there are additional measurable non-irradiated disease sites, this may be evaluated for response as well. If multiple lesions are irradiated, we advise that a single lesion will be treated to a higher dose and other lesions considered for lower doses, and that one site always remain unirradiated if a patient has ≥2 sites of disease.\n\nAge ≥18 years. Because no dosing or adverse event data are currently available on the use of TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells in combination with radiation therapy in patients \\\u003C18 years of age, children are excluded from this study.\n\nPatients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nLife expectancy ≥3 months per PI or treating physician's discretion.\n\nA female patient is eligible to participate if at least one of the following conditions applies:\n\na. Not a woman of childbearing potential (WOCBP). OR\n\nA WOCBP who agrees to follow the contraceptive guidelines in Appendix 5 during the study treatment period and for 6 months post-TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n\nWOCBP must have a negative urine pregnancy test within 72 hours prior to the start of lymphodepleting chemotherapy. If a WOCBP has a urine pregnancy test that cannot be confirmed as negative, a serum (beta-human chorionic gonadotropin \\[B-hCG\\]) pregnancy test will be required.\n\nThe effects of TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells on the developing human fetus are unknown. Radiation therapy is absolutely contraindicated in pregnant women. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\nApproved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.\n\nA female patient who becomes pregnant, or suspects pregnancy while she or her partner is participating in this study, must immediately notify her doctor. Female patients who become pregnant will be taken off study.\n\nMale patients treated or enrolled on this protocol must agree to follow the contraceptive guidelines in Appendix 5 prior to study entry and for the duration of study participation and for 6 months post-TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion. Male patients who father a child or suspect that they have fathered a child must immediately notify their doctor.\n\nPatients must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nPatients must have adequate organ function as defined below within 10 days prior to the start of lymphodepleting chemotherapy:\n\nTable 1. Adequate Organ Function Laboratory Values\n\nSystemic Function Test Laboratory Value Hematologic ANC ≥ 1500\u002FµL Platelets ≥ 100,000\u002FµL Hemoglobin ≥9.0 g\u002FdLa Renal Creatinine ≤ 1.5 x ULNb OR CrCl by Cockcroft-Gault ≥30 mL\u002Fmin for patients with creatinine formula \\> 1.5 x ULNb Hepatic Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\>1.5 x ULN AST and ALT ≤2.5 x ULN (≤5 x ULN for patints with liver metastases) Coagulation PT\u002FINR ≤1.5 x ULN unless patien is receiving anticoagulant aPTT therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT=alanine aminotransferase; ANC=absolute neutrophil count; aPTT=activated partial thromboplastin time; AST=aspartate aminotransferase; CrCl=creatinine clearance; INR=international normalized ratio; PT=prothrombin time; ULN=upper limit of normal.\n\n1. Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks of the screening test. Patients may be on a stable dose of erythropoietin (≥ approximately 3 months).\n2. Serum creatinine and CrCl should be interpreted and calculated per institutional standard.\n\n   Left ventricular ejection fraction \\>50%.\n\n   Adequate respiratory reserve defined as dyspnea Grade 0 or 1 and saturated oxygen \\>92% in room air. See Table 2 for a grading scale of dyspnea per the CTCAE v5.0.\n\n   Table 2. Dyspnea grading scale.\n\n   Grade 0 - No shortness of breath Grade 1 - Shortness of breath with moderate exertion Grade 2 - Shortness of breath with minimal exertion; limiting instrumental ADL Grade 3 - Shortness of breath at rest; limiting self-care ADL Grade 4 - Life threatening consequences; urgent intervention indicated Grade 5 - Death\n\n   Prior treatment with TROP2-targeted therapy will be allowed.\n\n   Willing to undergo mandatory blood collections and biopsies as required by the study.\n\n   Willing to sign consent for long-term follow-up on protocol PA17-0483.\n\n   Willing to stay within a 2-hour drive (approximately 100-mile radius) of the study site during the first 4 weeks after the TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n\n   Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n   Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\n   Ability to understand and the willingness to sign a written informed consent document.\n\n   Exclusion Criteria:\n   1. Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 6 months post TROP2 CAR\u002FIL-15 TGFBR2 KO NK cell infusion.\n   2. Has received systemic anticancer therapy within 2 weeks or 5 half-lives, whichever is shorter, prior to the start of lymphodepleting chemotherapy. For patients treated with monoclonal antibodies, at least 3 weeks must have elapsed prior to the start of lymphodepleting chemotherapy. Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks after the last dose of the previous investigational agent.\n   3. Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 neuropathy, alopecia, or other non-relevant AEs may be deemed eligible at the discretion of the principal investigator (PI)\u002Fco-PIs. If a patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to the start of lymphodepleting chemotherapy.\n   4. If patients receive RT within 2 weeks of the start of lymphodepleting chemotherapy, they must not require corticosteroids, and not have had radiation pneumonitis.\n   5. Has received a live vaccine within 6 weeks prior to TROP2 CAR\u002FIL-15 TGFBR2 KO NK infusion and for at least 24 months post infusion. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza and COVID-19 vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n   6. Prior CAR T or NK cell or other genetically modified T or NK cell therapy.\n   7. Has diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent).\n   8. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to patients who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers.\n   9. Known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate if they completed radiation therapy, are clinically stable, and without requirement of steroid treatment for at least 2 weeks prior to study enrollment.\n   10. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.\n   11. History of interstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD. 12. Active infection requiring systemic therapy.\n\n   13\\. Known human immunodeficiency virus (HIV) infection.\n\n   14\\. Known active or chronic hepatitis B or hepatitis C virus infection.\n\n   15\\. Known history of active tuberculosis (Mycobacterium tuberculosis).\n\n   16\\. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n\n   17\\. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\n   18\\. Has had an allogenic tissue\u002Fsolid organ transplant.\n\n   19\\. Clinically significant cardiovascular disease within 12 months prior to the start of lymphodepleting chemotherapy, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebrovascular event, or cardiac arrhythmia associated with hemodynamic instability. NOTE: medically controlled arrhythmia would be permitted.\n\n   20\\. Prolongation of corrected QT interval using Fridericia's formula to \\>480 milliseconds.\n\n   21\\. Patients with bleeding or thrombotic disorders or at risk for severe hemorrhage. Patients with known deep vein thrombosis\u002Fpulmonary embolism who are on appropriate anti-coagulation treatment are eligible.\n\n   22\\. Patients with history of ≥Grade 3 stomatitis or mucositis with prior therapy.\n\n   23\\. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide and fludarabine or other agents used in study.",{"count":470,"type":20},33,[49],"To find the recommended dose of an investigational therapy called chimeric antigen receptor (CAR).TROP2\u002Finterleukin (IL)15-transduced TGFBR2 KO cord blood (CB)-derived natural killer (NK) cells (TROP2 CAR\u002FIL-15 TGFBR2 KO NK cells) that can be given with and without preconditioning radiation therapy in patients with advanced head and neck squamous cell carcinoma.",[474],"Head and Neck Cancer",{"date":177,"type":31},{"date":477,"type":31},"2025-12-19",{"date":423,"type":20},{"name":37,"class":38},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":16,"minAge":486,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":21,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":39},"100592256","bayesian-neurobehavioral-phenotyping-from-mechanism-identification-to-personalized-neuromodulation-treatments-r61-phase-100592256","NCT06991062","Bayesian Neurobehavioral Phenotyping: From Mechanism Identification to Personalized Neuromodulation Treatments. R61 PHASE","Inclusion Criteria:\n\n1. Age 21 to 60 years\n2. Report smoking on average, 5 or more cigarettes, little cigars and\u002For cigarillos per day, within the past 30 days preceding the screening visit.\n3. Expired carbon monoxide (CO) ≥ 6ppm and\u002For test positive for cotinine using a urine cotinine test on day of study visit.\n4. Able to follow verbal and written instructions in English and complete all aspects of the study.\n5. Have an address and telephone number where they may be reached.\n6. Subjects must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and does not include shelters, halfway houses, treatment centers, or group homes.\n7. Meet safety criteria for EEG.\n8. Be willing to vape from an e-cigarette during specified tasks.\n9. Meet safety criteria for rTMS. Note that if a participant is not eligible for rTMS but is eligible for EEG, they may complete the EEG portion of the study.\n10. Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry)\n11. Provides written informed consent and agree to all assessments and study procedures.\n12. Agrees to complete telehealth (live audio-video conference and\u002For phone) and in-person visits and to be contacted via text.\n\n    Exclusion Criteria:\n13. rTMS exposure for treatment or research purposes in the last 6 months.\n14. History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.\n15. Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).\n16. History of brain surgery, implanted electronic device, metal in the head.\n17. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)\n18. History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.\n19. Reports vision problems that are not treated.\n20. Has a hairstyle not compatible with the EEG and unwilling to modify hairstyle (e.g., braids, ponytails, dreadlocks, non-removable hair extensions or wigs, etc.) to accommodate the EGG net that is required to be worn on the scalp during the experimental procedure.\n21. Reports current diagnosis or history of type I diabetes.\n22. Currently using insulin.\n23. Have undergone bariatric surgery.\n24. Currently being enrolled in a weight loss program.\n25. Takes any prescription or over the counter medications or supplements to control weight and\u002For appetite.\n26. Self-report a history of or current diagnosis of a mental health condition.\n27. Reports insomnia (\\\u003C4 hours sleep per night, in 3 or more nights per week in the last 3 months)\n28. Reports \\\u003C4 hours of sleep the day of the visit\n29. Reports using marijuana on a daily basis.\n30. Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.\n31. Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).\n32. Females who report averaging more than 7 alcoholic drinks, or males who report averaging more than 14 alcoholic drinks in a single week in the last 30 days.\n33. Current use of certain medications (last 3 months):\n\n    Investigational drugs. Drugs of anti or pro-convulsive action. Medications with psychotropic effects (e.g., antidepressants, antipsychotics).\n\n    Medications known to increase risk of seizure Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix). Nicotine replacement therapy with the intent to quit smoking (e.g., patches, gum, lozenge, pouches, etc).\n34. Being pregnant or lactating\n35. Self-reported noise-induced hearing loss or tinnitus.\n36. Currently participating in any other research study.\n37. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and\u002For Study Physician.\n\n37\\. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and\u002For Study Physician.\n\n38\\. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.","21 Years","60 Years",{"count":258,"type":20},[169],"The goal of this clinical research study is to learn more about whether individual differences in brain responses to emotional triggers impact rTMS (repetitive transcranial magnetic stimulation) responses in people who smoke.",[492],"Smoking",{"date":303,"type":31},{"date":495,"type":31},"2025-02-19",{"date":497,"type":20},"2028-12-01",{"name":37,"class":38},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":505,"sex":190,"minAge":17,"maxAge":506,"enrollmentInfo":507,"targetDuration":4,"studyType":21,"phases":509,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":39},"100580931","expanding-access-to-cervical-cancer-screening-through-primary-hr-hpv-testing-and-self-sampling-a-multicomponent-intervention-for-safety-net-health-systems-100580931","NCT06843720","Expanding Access to Cervical Cancer Screening Through Primary HR-HPV Testing and Self-sampling: a Multicomponent Intervention for Safety Net Health Systems","Inclusion Criteria:\n\nPopulations involved in the research are:\n\n1. stakeholder advisory board members;\n2. patients eligible for cervical cancer screening participating in the cluster randomized stepped-wedge trial;\n3. patients and community members participating in formative research activities;\n4. providers, clinic staff, and other health system stakeholders from partnering health systems;\n5. Project ECHO Participants (providers, clinic staff, and other health system stakeholders from partner and non-partner institutions);\n6. Other Clinical Networks (providers, clinic staff and other health system stakeholders from partner and non-partner institutions)\n\nThe eligibility criteria for each are:\n\nPatients eligible for cervical cancer screening:\n\n* Currently a resident in the state of Texas\n* Attend for care at a partner clinic enrolled in the study\n* Women and persons with a cervix\n* Age 25-65\n* Due or past due for cervical cancer screening\n\nPatients and community members participating in formative research activities:\n\n• Purposively identified as a stakeholder for formative research by research staff\n\nProviders, clinic staff, and other health system stakeholders from partnering health systems:\n\n* Employed at least part-time by a partnering health system\n* Age 18+\n\nProject ECHO Participants:\n\n* Participate in at least one Project ECHO session\n* Age 18+\n\nOther Clinical Networks:\n\n* Participate in at least one clinical network session\n* Age 18+\n\nExclusion Criteria:\n\nPatients eligible for cervical cancer screening:\n\n* Report being currently pregnant\n* History of total hysterectomy\n* History of cervical cancer\n\nOther study populations:\n\n• Unable to communicate in English or Spanish\n\nVulnerable Populations Participants\u002Fsamples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults, or prisoners) will be prohibited from participation.",true,"65 Years",{"count":508,"type":20},7100,[169],"To learn about the attitudes toward implementing self-collection among healthcare providers and staff, participants, and other stakeholders; and to inform the development of patient education and provider training materials to aid in the implementation of self-collection in clinical settings.",[512],"HR-HPV Testing",{"date":303,"type":31},{"date":515,"type":31},"2025-02-17",{"date":517,"type":20},"2031-03-31",{"name":37,"class":38},""]