[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"indolent-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:indolent-non-hodgkin-lymphoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,73,102,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100533263","phase-1-studying-tak-243-in-patients-with-advanced-cancer-100533263",false,"NCT06223542","Studying TAK-243 in Patients With Advanced Cancer","A Phase I Study to Investigate the Safety of the Ubiquitin Activating Enzyme Inhibitor TAK-243 in Adult Solid Tumor and Lymphoma Patients","Inclusion Criteria:\n\n* Patients with histologically documented advanced or metastatic solid tumors with relapsed or refractory disease who have received standard-of-care or approved therapies known to confer clinical benefit, or patients with aggressive lymphomas who have received ≥ 2 prior lines of lymphoma-directed therapy and who do not have remaining effective treatment options (including transplant). Additionally, patients with indolent lymphomas must meet criteria for treatment.\n* Patients must have measurable or evaluable disease\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Hemoglobin \\>= 9 g\u002FdL (patients may be transfused to achieve this value; elevated indirect bilirubin due to post-transfusion hemolysis is allowed)\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 75,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN OR =\\\u003C 5 x institutional upper limit of normal for patients with liver metastases at baseline\n* Creatinine =\\\u003C 1.5 x institutional ULN OR creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 by Cockcroft-Gault\n* Any prior therapy must have been completed \\>= 4 weeks, or \\>= 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol. Prior definitive radiation should have been completed \\>= 4 weeks prior to enrollment; prior palliative radiation should have been completed \\>= 2 weeks prior to enrollment. Patients must be \\>= 2 weeks since any investigational agent administered as part of a Phase 0 study (where a sub-therapeutic dose of drug is administered) and should have recovered to grade 1 or baseline from any toxicities\n* Female patients who:\n\n  * Are postmenopausal (age-related amenorrhea \\>= 12 consecutive months or follicle-stimulating hormone \\> 40 mIU\u002FmL), for at least 1 year before the screening visit, OR\n  * Are surgically sterile (i.e., who had undergone hysterectomy or bilateral oophorectomy), OR\n\nIf they are of childbearing potential:\n\n* Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), or\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)\n\n  * Male patients, even if surgically sterilized (i.e., status postvasectomy), who:\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), or\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[eg, calendar, ovulation, symptothermal, postovulation methods for the female partner\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)\n\n  * The effects of TAK-243 on the developing human fetus are unknown. For this reason and because ubiquitin-activating enzyme inhibitors 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. 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. 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 TAK-243 administration\n  * Ability to understand and the willingness to sign a written informed consent document\n  * Willingness to provide blood for research purposes\n  * For expansion phase patients, willingness to undergo 2 core needle biopsy procedures for research purposes if there is a lesion or lesions amenable to repeat biopsy\n  * Patients on anticoagulation therapy are eligible for this study in the absence of anticipated drug-drug interactions (DDI) between the anticoagulation agent and TAK-243. If DDI are anticipated and another anticoagulation agent that is compatible with TAK-243 exists, the patient will be transitioned to this alternative, TAK-243-compatible anticoagulation agent\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Life-threatening illness unrelated to cancer\n* Patients with uncontrolled coagulopathy or bleeding disorder\n* Known hepatic cirrhosis or severe pre-existing hepatic impairment\n* Known cardiopulmonary disease defined as:\n\n  * Unstable angina pectoris;\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV);\n  * Myocardial infarction (MI) within 6 months prior to first dose (patients who had ischemic heart disease such as a \\[acute coronary syndrome (ACS)\\], MI, and\u002For revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll);\n  * Cardiomyopathy\n* Clinically significant arrhythmia:\n\n  * History of polymorphic ventricular fibrillation or torsade de pointes,\n  * Permanent atrial fibrillation (a fib), defined as continuous a fib for \\>= 6 months,\n  * Persistent a fib, defined as sustained a fib lasting \\> 7 days and\u002For requiring cardioversion in the 4 weeks before screening,\n  * Grade 3 a fib defined as symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker) or ablation, and\n  * Patients with paroxysmal a fib or \\\u003C grade 3 a fib for period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen\n* Prolonged rate corrected QT (QTc) interval \\>= 470 m\u002Fsec, calculated according to institutional guidelines\n* Uncontrolled high blood pressure (i.e., systolic blood pressure \\> 180 mm Hg, diastolic blood pressure \\> 95 mm Hg)\n* Known moderate to severe chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis\n* Major surgery within 14 days before the first dose of any study drug\n* Female patients who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s)\n* Male patients who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s)\n* Patients with known brain metastases or carcinomatous meningitis are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for \\>= 1 month after treatment of the brain metastases. Patients on anti-seizure medications may be enrolled at the discretion of the principal investigator\n* TAK-243 is primarily metabolized by CYP3A4\u002F5. Therefore, the concomitant use of strong inhibitors of CYP3A4\u002F5 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir) and strong inducers of CYP3A4\u002F5 (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) is not permitted from 14 days prior to enrollment until the end of the study\n\n  * TAK-243 is a substrate for both organic anion transporting polypeptides (OATP) in human hepatocytes and the drug efflux transporter BCRP (ABCG2). Therefore, concomitant use of drugs that are strong inhibitors of BCRP or OATP is not permitted from 14 days prior to enrollment until the end of the study\n  * Other medications that are prohibited while on TAK-243 treatment include herbal medications\u002Fpreparations (except for vitamins). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of\n  * As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients undergoing vaccination with live vaccines and live attenuated vaccines in the 30 days prior to receiving TAK-243, during the study, and for 100 days after the last dose of study drug. Inactivated vaccines are permitted\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAK-243\n* Patients with evidence of chronic hepatitis B virus (HBV) infection who are currently on treatment are eligible if they have an undetectable HBV viral load\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* Known human immunodeficiency virus (HIV)-positive patients who meet the following criteria will be considered eligible:\n\n  * CD4 count \\> 350 cells\u002Fmm\\^3\n  * Undetectable viral load for 6 months prior to enrollment\n  * Maintained on modern therapeutic regimens utilizing non-CYP-interactive agents\n  * No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections\n* Pregnant and lactating\u002Fbreast-feeding women are excluded from this study because TAK-243 is a UAE-inhibiting agent with the potential for teratogenic or abortifacient effects and there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TAK-243","ALL","18 Years",{"count":19,"type":20},95,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the side effects and best dose of ubiquitin-activating enzyme (UAE) inhibitor TAK-243 (TAK-243) in treating patients with a solid tumor that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) and in patients with lymphoma. TAK-243 is a drug that binds to and inhibits the ubiquitin-activating enzyme, an enzyme that is more active on cancer cells than healthy cells, inhibiting tumor cell proliferation and survival.",[26,27,28,29,30,31],"Advanced Lymphoma","Advanced Malignant Solid Neoplasm","Indolent Non-Hodgkin Lymphoma","Metastatic Malignant Solid Neoplasm","Recurrent Malignant Solid Neoplasm","Refractory Malignant Solid Neoplasm","RECRUITING","2026-05-12",{"date":35,"type":36},"2026-05-13","ACTUAL",{"date":38,"type":36},"2025-03-24",{"date":40,"type":20},"2027-04-15",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100506633","the-effects-of-exercise-on-immune-phenotype-of-indolent-non-hodgkin-lymphoma-and-chronic-lymphocytic-leukemia-patients-100506633","NCT05876923","The Effects of Exercise on Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients","The Effects of Acute and Chronic Exercise on the Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients","Inclusion Criteria:\n\n* English speaking\n* Between the ages of 18-80\n* Histologically confirmed diagnosis of indolent non-Hodgkin lymphoma (NHL) will be required to participate in Aim 2 (CLL\u002FSLL only), aim 3 and 4 (indolent NHL) and aim 5 (indolent NHL) of this study\n\nExclusion Criteria:\n\n* Healthy subjects participating in Aim 1 will be excluded if they have known cardiovascular or pulmonary disease (e.g. heart disease, coronary artery disease, chronic obstructive pulmonary disease \\[COPD\\], asthma, etc.) an orthopedic or musculoskeletal limitation which would limit ability to exercise or are a current or former smoker\n* Indolent NHL individuals receiving treatment must have least 8 weeks of planned treatment remaining and those who have already received treatment must be at least 6 months post and have no planned treatments during the 12-week intervention period to be eligible. Individuals that are participating prior to receiving treatment must not have any scheduled treatments during their participation. Individuals will be excluded if they have uncontrolled hypertension, cardiac illness, or are not approved by their oncologist to participate",true,"80 Years",{"count":55,"type":20},70,[57],"NA","This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase survival, decrease treatment-related side effects, and improve immune function. Information learned from this study may help researchers determine whether a particular exercise regimen can be used to strengthen the immune system of indolent NHL and CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.",[60,61],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Indolent Non-hodgkin Lymphoma","2026-04-06",{"date":64,"type":36},"2026-04-09",{"date":66,"type":36},"2023-06-12",{"date":68,"type":20},"2028-04",{"name":70,"class":71},"Mayo Clinic","OTHER",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":44},"100430312","phase-2-acalabrutinib-and-obinutuzumab-for-the-treatment-of-previously-untreated-follicular-lymphoma-or-other-indolent-non-hodgkin-lymphomas-100430312","NCT04883437","Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas","An Open-Label Phase 2 Trial of Acalabrutinib Plus Obinutuzumab in Patients With Untreated, Low Tumor Burden Follicular Lymphoma and Other Indolent Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n* Men and women \\>= 18 years of age\n* Patients will need to have one of the following clinical scenarios:\n\n  * Previously untreated follicular lymphoma grade 1-3a with low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria\n  * Previously untreated follicular lymphoma grade 1-3a with high tumor burden by GELF criteria but who are unable or unwilling to receive standard front-line treatment approaches\n  * Previously untreated marginal zone lymphoma, lymphoplasmacytic lymphoma, or any other indolent B-cell lymphoproliferative disorder with low tumor burden by GELF criteria or who are unable\u002Funwilling to receive more intensive front-line treatment\n  * Previously untreated mantle cell lymphoma who would otherwise be appropriate candidates for watchful waiting OR who have symptomatic disease but are not candidates for or decline standard induction approaches\n* Patients with previously untreated low tumor burden FL (criterion above) must have measurable and\u002For assessable disease defined as at least one involved lymph node or extranodal disease site that measures \\>= 1.5cm in greatest diameter\n* Patients who meet inclusion criteria above are eligible as long as they meet one of the following criteria for measurable\u002Fassessable disease:\n\n  * At least one involved lymph node or extranodal disease site measuring \\> 1.5cm in greatest diameter\n  * Pathologically-confirmed bone marrow or peripheral blood involvement that can be reassessed for response\n  * Pathologically confirmed splenic or extranodal involvement with at least one known site of disease remaining after diagnostic biopsy that can be reassessed (i.e., patients with splenic marginal zone lymphoma who complete splenectomy and have no other detectable disease would not be eligible)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Woman of childbearing potential (WOCBP) and men enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study participation, and for at least 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab, whichever is longer. 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* Women of childbearing potential must have a negative serum or urine pregnancy test prior to starting therapy\n* Willing and able to participate in all required evaluations and procedures in this study protocol\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information\n\nExclusion Criteria:\n\n* The presence or history of histologically transformed or co-existing high-grade or aggressive non-Hodgkin lymphoma\n* Confirmed active or prior central nervous system disease\n* Prior receipt of lymphoma-directed therapy or prior antibody-based therapy (except for anti-microbial therapy for infection-associated marginal zone lymphoma such as hepatitis C or H pylori)\n\n  * A short course of steroids is permitted for patients aside from those in the low tumor burden FL cohort. This course may be no more than 14 days and steroids must be discontinued (or tapered to =\\\u003C 10mg prednisone or equivalent) no later than 3 days after initiation of study treatment. Patients in the low tumor burden FL cohort may not receive corticosteroids as an anti-lymphoma therapy at any time before starting treatment\n* Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for \\>= 2 years or which will not limit survival to \\\u003C 5 years\n* Clinically significant cardiovascular disease such as symptomatic ventricular arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled, asymptomatic atrial fibrillation can enroll on study if deemed appropriate by the investigator\n* Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication\n* Known history of human immunodeficiency (HIV) or any active significant infection (e.g., bacterial, viral, or fungal) within 14 days of cycle 1. Patients with uncomplicated viral or bacterial infections that are being managed with oral antibiotics and\u002For supportive care alone are eligible\n* Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components\n* Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)\n* Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura)\n* Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening\n* Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor\u002Finducer\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with proton pump inhibitors (e.g, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study\n* History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug. Patients with a transient ischemic attack which has resolved and for which there are no ongoing symptoms are eligible\n* Major surgical procedure within 28 days of first dose of study drug (not including a diagnostic procedure to make the lymphoma diagnosis). Note: If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n* Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and must be willing to undergo deoxyribonucleic acid (DNA) PCR testing during the study to be eligible. Those who are 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 to be eligible and have completed appropriate anti-viral treatment. Those who are hepatitis C PCR positive will be excluded. Anti-viral therapy for patients with hepatitis-C associated marginal zone lymphoma will not be considered a prior anti-lymphoma treatment\n* Absolute neutrophil count (ANC) \\\u003C 1,000\u002FmcL\n* Platelet count \\\u003C 50,000\u002FmcL (Unless felt to be related to underlying disease)\n* Total bilirubin \\>= 1.5 x the upper limit of normal (ULN). Isolated bilirubin \\> 1.5 x ULN is permitted if the direct proportion is \\\u003C 35%\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\> 2.5 x ULN\n* Creatinine clearance =\\\u003C 40 mL\u002Fmin\u002F1.73m\\^2\n* Breastfeeding or pregnant\n* Concurrent participation in another therapeutic clinical trial",{"count":81,"type":20},49,[83],"PHASE2","This phase II trial studies the effect of acalabrutinib and obinutuzumab in treating patients with follicular lymphoma or other indolent non-Hodgkin lymphoma for which the patient has not received treatment in the past (previously untreated). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib and obinutuzumab may kill more cancer cells.",[86,87,88,28,89,90,91,92],"Grade 1 Follicular Lymphoma","Grade 2 Follicular Lymphoma","Grade 3a Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Lymphoproliferative Disorder","Mantle Cell Lymphoma","Marginal Zone Lymphoma","2026-02-05",{"date":95,"type":36},"2026-02-09",{"date":97,"type":36},"2021-09-03",{"date":99,"type":20},"2027-01-15",{"name":101,"class":71},"Emory University",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":44},"100379683","phase-1-study-of-kappa-chimeric-antigen-receptor-car-t-lymphocytes-co-expressing-the-kappa-and-cd28-cars-for-relapsedrefractory-kappa-non-hodgkin-lymphoma-and-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-100379683","NCT04223765","Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed\u002FRefractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma.","Phase 1 Study of the Administration of T Lymphocytes Expressing the Kappa Chimeric Antigen Receptor (CAR) and CD28 Endodomain for Relapsed\u002FRefractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma.","Note: During the period of cell procurement and CAR.κ.28 T cell production, subjects are allowed to receive additional standard of care chemotherapy to stabilize their disease if the treating physician feels it is in the subject's best interest. For subjects requiring bridging chemotherapy while awaiting manufacture of their CAR.κ.28 T-cells, details regarding treatment(s) administered including dose, frequency, number of cycles, etc. will be collected.\n\nInclusion Criteria for the Study\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in this study:\n\n1. Written informed consent and HIPAA authorization for release of personal health information.\n2. Adults ≥18 years of age.\n3. Diagnosis of relapsed\u002Frefractory chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma OR histologically confirmed B-cell NHL, including the following types defined by WHO 2016:\n\n   Aggressive Lymphomas:\n   * DLBCL not otherwise specified (NOS)\n   * T cell\u002Fhistiocyte rich large B cell lymphoma; primary cutaneous DLBCL, leg type; EBV-positive DLBCL NOS; DLBCL associated with chronic inflammation; Lymphomatoid granulomatosis; Large B-cell lymphoma with IRF4 rearrangement; Intravascular large B-cell lymphoma; ALK-positive large B-cell lymphoma\n   * Primary mediastinal (thymic) large B-cell lymphoma\n   * High grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangement; high grade B-cell lymphoma, NOS\n   * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n   * Transformation of indolent lymphoma or CLL to DLBCL will also be included\n   * Burkitt lymphoma\n\n   Indolent Lymphomas:\n   * Follicular lymphoma grade 1-3b\n   * Splenic marginal zone lymphoma\n   * Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue\n   * Nodal marginal zone lymphoma\n   * Mantle cell lymphoma\n   * Subjects with central nervous system (CNS) disease will not be excluded as long as it has been stable for 3 months\n\n   Subjects with bone marrow only involvement are eligible\n4. Subjects relapsed after autologous or allogeneic stem cell transplant are eligible for this study.\n5. Subjects who have received prior CD19-directed CAR therapies for relapsed\u002Frefractory disease are eligible for this study. However, at least 3 months must have passed since the subject received CD19 CAR-T cells.\n6. Patients with aggressive lymphomas must have relapsed or refractory disease after having received at least 2 prior lines of systemic therapy, including, at a minimum:\n\n   * An anti-CD20 monoclonal antibody\n   * An anthracycline containing chemotherapy regimen (if eligible)\n   * An autologous stem cell transplant (if eligible)\n7. For indolent lymphomas, subjects must have received at least 2 prior lines of therapy for their lymphoma\n8. Subjects with specifically relapsed\u002Frefractory chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma must have received at least 2 prior therapy regimens which can include, but not limited to:\n\n   * A combination of an anti-CD20 monoclonal antibody and an alkylating agent, OR\n   * A Bruton's Tyrosine Kinase Inhibitor, OR\n   * A BCL-2 inhibitor in combination with an anti-CD20 monoclonal antibody\n9. Subjects 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 at the investigator's discretion.\n10. Kappa-positive expression on lymphoma or CLL\u002FSLL tissue sample, or kappa restriction on flow cytometry (archival or fresh) as confirmed by institutional hematopathology standard (result must be confirmed at the time of cell procurement).\n11. Karnofsky score of \\> 60%\n12. Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Female subjects of childbearing potential will also be instructed to tell their male partners to use a condom.\n\nExclusion Criteria for the Study\n\nSubjects meeting any of the following exclusion criteria will not be able to participate in this study (procurement, lymphodepletion and cell infusion):\n\n1\\. A history of intolerance to bendamustine or fludarabine. Note: subjects with known history of intolerance to bendamustine may be considered for lymphodepletion with cyclophosphamide and fludarabine at the discretion of the clinical investigator.\n\n2 Subject is pregnant or lactating. 3 Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving \\\u003C10 mg daily may be enrolled at discretion of investigator. 4 Active infection with HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy as well as no history of HIV. Subjects are required to have negative HIV antibody, negative HTLV1 and HTLV2 antibodies, negative hepatitis B surface antigen, and negative HCV antibody or viral load.\n\nEligibility Criteria to be Met Prior to Procurement\n\n1. Subject has signed a consent to undergo cell procurement.\n2. Evidence of adequate organ function as defined by:\n\n   * Total bilirubin \\\u003C1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \\>1.5 mg\u002FdL if their conjugated bilirubin is \\\u003C1.5 × ULN)\n   * AST and ALT \\\u003C 5x ULN\n   * Pulse oximetry of \\>90% on room air\n   * Creatinine ≤ 2 x ULN\n3. Imaging results from within 120 days prior to procurement to assess presence of active disease.\n4. Confirmed kappa-positive expression on lymphoma or CLL\u002FSLL tissue or bone marrow sample (archival or fresh) as confirmed by pathology.\n5. Subject has adequate cardiac function, defined as:\n\n   * No ECG evidence of acute ischemia\n   * No ECG evidence of active, clinically significant conduction system abnormalities\n   * Prior to study entry, any ECG abnormality at screening not felt to put the subject at risk has to be documented by the investigator as not medically significant\n   * No uncontrolled angina or severe ventricular arrhythmia\n   * Left ventricular ejection fraction (LVEF) \\>40% as measured by ECHO, with no additional evidence of decompensated heart failure, performed within 30 days prior to procurement\n6. In women of child-bearing potential, negative serum pregnancy test within 72 hours prior to procurement or documentation that the subject is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for \\> 1 year.\n\nEligibility Criteria to be Met Prior to Lymphodepletion\n\n1. Written informed consent to enroll in the CAR-T cell therapy trial must be obtained prior to lymphodepletion.\n2. The last bridging therapy should be completed at least 3 weeks prior to lymphodepletion.\n3. Subjects who have received bridging therapy will be reassessed with imaging within 5 days prior to lymphodepletion and at least 3 weeks after bridging therapy. If a patient did not receive bridging chemotherapy, they will be imaged within 10 days prior to lymphodepletion.\n4. Adequate organ function per the following criteria are required prior to lymphodepletion:\n\n   * Adequate bone marrow function, as defined by:\n\n     * ANC \\>1.0 × 109\u002FL\n     * Platelets \\>50 × 109\u002FL unless related to lymphoma involvement (independent of transfusion within 7 days of lymphodepletion)\n   * Total bilirubin ≤1.5 × ULN (subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level \\>1.5 mg\u002FdL if their conjugated bilirubin is \\\u003C1.5× ULN)\n   * AST and ALT ≤ 5× ULN\n   * Pulse oximetry of \\> 90% on room air\n   * Creatinine ≤2 x ULN\n   * If subjects display any clinical signs or symptoms of cardiac dysfunction after receiving bridging chemotherapy, they will undergo repeat ECG and ECHO to reassess their cardiac function and status\n5. In female subjects of childbearing potential, a negative serum pregnancy test within 72 hours prior to l ymphodepletion or documentation that the subject is post-menopausal or has been surgically sterilized.\n\n   Post-menopausal status must be confirmed with documentation of absence of menses for \\> 1 year.\n6. In subjects with CLL\u002FSLL, a bone marrow biopsy within 28 days prior to lymphodepletion.\n7. In subjects with WM\u002FLPL, a bone marrow biopsy within 90 days prior to lymphodepletion.\n8. Subjects must have autologous transduced activated T-cells that meet the Certificate of Analysis (CofA) acceptance criteria.\n9. Has not received any tumor vaccines within the previous six weeks prior to lymphodepletion.\n10. Has not received investigational agent or cancer-directed therapy within the previous 3 weeks, or 5 half-lives (whichever is shorter), prior to lymphodepletion.\n11. Subjects may not be receiving strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) up through 72 hours after the last dose of bendamustine, as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002F for an updated list of strong inhibitors of CYP1A2\n12. Subject is not taking a prohibited or contraindicated medication listed in the protocol. Contraindicated medications should be discontinued at least two weeks prior to the scheduled lymphodepletion or by at least 5 half-lives of the contraindicated medication, whichever is shorter.\n13. No evidence of uncontrolled infection or sepsis.\n\nEligibility Criteria to be Met Prior to Cell Infusion After Lymphodepletion\n\n1. No evidence of uncontrolled infection or sepsis.\n2. Evidence of adequate organ function as defined by:\n\n   1. Total bilirubin ≤2 × ULN, unless attributed to Gilbert's syndrome\n   2. AST \\\u003C 5 × ULN\n   3. ALT \\\u003C 5 × ULN\n   4. Creatinine ≤ 3 x ULN\n3. Subject has no clinical indication of rapidly progressing disease in the opinion of the clinical investigator.\n4. Subject is a good candidate for treatment with CAR.κ.28 cell product per the clinical investigator's discretion.",{"count":110,"type":20},20,[23],"This study will combine both T cells and antibodies in order to create a more effective treatment. The treatment tested in this study uses modified T-cells called Autologous T Lymphocyte Chimeric Antigen Receptor (ATLCAR) cells targeted against the kappa light chain antibody on cancer cells. For this study, the anti-kappa light chain antibody has been changed so instead of floating free in the blood, a part of it is now joined to the T cells. Only the part of the antibody that sticks to the lymphoma cells is attached to the T cells. When an antibody is joined to a T cell in this way, it is called a chimeric receptor. The kappa light chain chimeric (combination) receptor-activated T cells are called ATLCAR.κ.28 cells. These cells may be able to destroy lymphoma cancer cells. They do not, however, last very long in the body so their chances of fighting the cancer are unknown.\n\nPrevious studies have shown that a new gene can be put into T cells to increase their ability to recognize and kill cancer cells. A gene is a unit of DNA. Genes make up the chemical structure carrying your genetic information that may determine human characteristics (i.e., eye color, height and sex). The new gene that is put in the T cells in this study makes an antibody called an anti-kappa light chain. This anti-kappa light chain antibody usually floats around in the blood. The antibody can detect and stick to cancer cells called lymphoma cells because they have a substance on the outside of the cells called kappa light chains.\n\nThe purpose of this study is to determine whether receiving the ATLCAR.κ.28 cells is safe and tolerable and learn more about the side effects and how effective these cells are in fighting lymphoma. Initially, the study doctors will test different doses of the ATLCAR.κ.28, to see which dose is safer for use in lymphoma patients. Once a safe dose is identified, the study team will administer this dose to more patients, to learn about how these cells affect lymphoma cancer cells and identify other side effects they might have on the body.\n\nThis is the first time ATLCAR.κ.28 cells are given to patients with lymphoma. The Food and Drug Administration (FDA), has not approved giving ATLCAR.κ.28 as treatment for lymphoma. This is the first step in determining whether giving ATLCAR.κ.28 to others with lymphoma in the future will help them.",[91,114,115,116,117,61],"Follicular Lymphoma","Splenic Marginal Zone Lymphoma","Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Nodal Marginal Zone Lymphoma",[119,120,121,122,123],"CAR T cells","Kappa","CD28","Lymphoma","T lymphocytes","2026-01-16",{"date":126,"type":36},"2026-01-20",{"date":128,"type":36},"2020-11-12",{"date":130,"type":20},"2043-03-22",{"name":132,"class":71},"UNC Lineberger Comprehensive Cancer Center",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100558915","phase-2-mrd-guided-de-intensification-of-bendamustinerituximab-for-indolent-non-hodgkin-lymphoma-100558915","NCT06557330","MRD Guided De-intensification of Bendamustine\u002FRituximab for Indolent Non-Hodgkin Lymphoma","HM-225: Measurable Residual Disease (MRD) Guided De-intensification of Bendamustine\u002FRituximab (BR) for Indolent Non-Hodgkin Lymphoma","Inclusion Criteria:\n\nPatients must have pathologically confirmed:\n\n* indolent Non-Hodgkin Lymphoma, consistent with one of the below diagnoses:\n* Follicular Lymphoma (Grade 1-3a)\n* Marginal Zone Lymphoma\n* Lymphoplasmacytic Lymphoma\n\nPatient may be treatment naïve or relapsed\u002Frefractory without having received prior Bendamustine or patients recently started on Bendamustine 90 mg\u002Fm2 with Rituximab 375 mg\u002Fm2 are eligible if C2D1 BR is no more than 14 days prior to enrollment and they otherwise meet eligibility criteria\n\n* Age \\> 18 years\n* ECOG performance status 0-2\n\nPatients must have normal organ and marrow function as defined below:\n\n* Absolute Neutrophil Count \\>1000mm3 and Hemoglobin \\>8 g\u002FdL (unless due to bone marrow involvement by lymphoma)\n* Total bilirubin \\> 1.5x upper limit of normal (patients with Gilbert's syndrome can have total bilirubin up to 3x upper normal limit)\n* Aspartate aminotransferase\u002F alanine aminotransferase (serum glutamic-oxaloacetic transaminase\u002F serum glutamic-pyruvic transaminase) \\\u003C 5 times institutional normal limits\n* Creatinine clearance \\> 30 Ml\u002Fmin\n\nExclusion Criteria:\n\n* Radiation or systemic treatment for lymphoma within the past 28 days prior to cycle 1 day 1 of BR.\n* Patients with pathologically confirmed transformed lymphoma, including diffuse large B cell lymphoma or other high grade lymphomas\n* Patients on active treatment for second malignancy with the exception of endocrine therapy for non-metastatic breast cancer, hormone therapy for prostate cancer, or local treatment for non-melanoma skin cancer.\n* Pregnant or breast-feeding. Refer to section 5.4 for further detail.\n* Failure to identify a dominant clonal sequence with ClonoSEQ from pre-treatment specimen or inadequate tissue for testing","99 Years",{"count":142,"type":20},24,[83],"This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of MRD adapted duration of BR for untreated or R\u002FR iNHL.",[122,61],"NOT_YET_RECRUITING","2025-01-03",{"date":149,"type":36},"2025-01-06",{"date":151,"type":20},"2025-06",{"date":153,"type":20},"2028-03-30",{"name":155,"class":71},"Fox Chase Cancer Center"]