[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Leland Metheny\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100443327","phase-2-hstar-gbm-hematopoetic-stem-cell-hpc-rescue-for-gbm-100443327",false,"NCT05052957","hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)","Phase II Trial O6-benzylguanine(BG) and Temozolomide(TMZ) Therapy of Glioblastoma Multiforme (GBM) With Infusion of Autologous P140K MGMT+Hematopoietic Progenitors to Protect Hematopoiesis","hSTAR GBM","Inclusion Criteria:\n\n* Patients with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone gross total tumor resection or near gross total resection (resection of \\>85% of enhancing tumor demonstrated by MRI) are eligible up to 35 days post-operatively. Patients with primarily infratentorial disease, or with multifocal,or leptomeningeal dissemination of disease will be excluded. In general, patients will not have \\> 1 cm residual measurable or evaluable disease after surgical tumor resection.\n* Patient must have unmethylated MGMT\n* Absence Of IDH1 or IDH2mutation on tumor tissue by a CLIA-approved immunohistochemistry or DNA sequencing test on local testing\n* Patients aged 18-75 years.\n* ECOG performance status 0-1or Karnofsky ≥ 70.\n* No myelosuppressive chemotherapy or hematopoietic cell transplantation prior to the diagnosis of GBM and no prior chemotherapy (including Gliadel BCNU wafers) for GBM\n* Life expectancy of at least 12 weeks.\n* No plan for hypofractionated radiation therapy\n* Adequate hematologic (absolute neutrophil count (ANC)≥ 1000\u002Fmm3, platelets ≥ 100,000\u002Fmm3, Hgb ≥ 9.5, hepatic (Bilirubin ≤ 2.0 mg\u002Fdl, AST and ALT less than or equal to 3 times institutional upper limit of normal, prothrombin time \\\u003C1.2 times normal), and renal (serum creatinine ≤ 2.0 mg\u002Fdl or Creatinine Clearance ≥ 60mL\u002Fmin\u002F1.73 m2for subjects with serum creatinine levels above institutional normal). These tests will be repeated within 2 weeks of treatment with BG and TMZ, and must meet the same criteria. -Post-operative steroids are i) tapered to ≤ 8mg dexamethasone\u002Fday(or equivalent)and ii) patient has been on a stable or decreasing steroid dose for the 7 days prior to enrollment\n* Patients of child-bearing potential must agree to using single barrier contraception.\n* Must be willing and able to understand provide informed consent.\n* Patient must have all sutures removed prior to registration\n* Patient must be considered to be clinically stable.\n* The subject will be identified as a candidate for an autologous transplant via an evaluation by a transplant physician per standard of care. Participants will be screened by their transplant physician and social work for a history of substance abuse per screening tool such as SIPAT. Any participant with positive screen for significant substance abuse will undergo evaluation and must have a treatment, management plan in place and must have formal review of medical team prior to initiation of transplant procedures.\n* No evidence of active infection.\n* Availability of 10unstained slides or FFPE sample of tumor for molecular or histopathological studies.\n* Negative screening for Hepatitis B, C and HIV\n\nExclusion Criteria:\n\n* Any known medical or hereditary condition associated with immunosuppression;orothermedical illness which may jeopardize patient safety.\n* Known history of HIV seropositivity. This exclusion is included for two reasons. First, there is evidence of decreased marrow reserve in HIV+ patients and antiviral treatment is associated with myelosuppression. Thus, drug treatment designed to be myelosuppressive may bemore toxic in this patient population. Second, extensive laboratory culturing of the bone marrow and peripheral blood progenitor cells is required. No preclinical samples which are HIV+ have been evaluated with the gene transfer modality proposed and thus the feasibility and safety of gene transfer and selection in HIV+ samples cannot yet be advocated. Such studies are planned so as to not preclude HIV+ patients in later studies.\n* Pregnant or lactating women. There is data to indicate that BCNU and TMZ is teratogenic and carcinogenic. Thus, its use in pregnant women would confer unnecessary risk to the fetus.\n* Patients with symptomatic pulmonary disease and other severe co-morbid respiratory conditions, including patients with active pulmonary infection and\u002For pulse oximetry \\\u003C 90% and a corrected DLCO \\\u003C 50% of predicted. However, subjects with a corrected DLCO in the range of 50-70% should have Pulmonologyclearance prior to intervention.\n* Patients with known diagnosis heart failure or cardiac insufficiency and an LVEF of \\\u003C 40%. History of acute coronary event including MI within 6 months prior to study enrollment.\n* Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmiaor bradycardia.Inability to undergo repeated MRI evaluation; or allergy or intolerance of Gadolinium-containing contrast agent.\n* Active illicit drug use or diagnosis of alcoholism.\n* Prior diagnosis of any malignant disease with the exception of non-melanomatous skin cancer, or carcinoma in situof the cervix, bladder, prostate, or breast, unless patient has been disease-free\u002Fin remission for ≥2 years prior to date of study enrollment.\n* Mental incapacity or psychiatric illness preventing informed consent.\n* History of Hepatitis B or C or Hepatitis grade ≥3 are excluded due to the potential for additional hepatotixicity","ALL","18 Years","75 Years",{"count":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This phase II trial studies the effect of P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine in treating participants with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor (resected). Chemotherapy drugs, such as 6-benzylguanine, temozolomide, and carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing. Placing P140K MGMT, a gene that has been created in the laboratory into bone marrow making the bone more resistant to chemotherapy, allowing intra-patient dose escalation which kills more tumor cells while allowing bone marrow to survive.",[28,29,30,31],"Glioblastoma Multiforme","Glioblastoma Multiforme, Adult","Supratentorial Glioblastoma","Supratentorial Gliosarcoma","RECRUITING","2025-11-19",{"date":35,"type":36},"2025-11-21","ACTUAL",{"date":38,"type":36},"2023-01-20",{"date":40,"type":22},"2026-12-01",{"name":42,"class":43},"Leland Metheny","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":66,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":44},"100568395","phase-2-abba-cord-dcbt-w-abatacept-for-agvhd-prophylaxis-100568395","NCT06680661","ABBA CORD: dCBT w\u002F Abatacept for aGVHD Prophylaxis","ABBA CORD: Double Umbilical Cord Blood Transplants With Abatacept for Graft Versus Host Disease Prophylaxis","Inclusion Criteria:\n\n* Patients with the following hematologic malignancies:\n\n  * Acute myelogenous leukemia (AML): High-risk and intermediate-risk AML including:\n\n    * Antecedent hematological disease (e.g., myelodysplasia (MDS))\n    * Treatment-related leukemia\n    * Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, complex cytogenetics)\n    * CR2 or CR3\n    * Induction failure or 1st relapse with \\\u003C 10% blasts in the marrow\n  * Acute lymphoblastic leukemia (ALL):\n\n    * High-risk CR1 including:\n\n      * Poor-risk cytogenetics (e.g., Philadelphia chromosome t(9;22)or 11q23 rearrangements)\n      * Philadelphia chromosome-like ALL\n      * Presence of minimal disease by flow cytometry after 2 or more cycles of chemotherapy\n    * No CR within 4 weeks of initial treatment\n    * Induction failure with \\\u003C 10% blasts in the marrow\n    * CR2 or CR3\n  * Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system or treatment related MDS.\n  * Bi-phenotypic or mixed-phenotypic acute leukemia in:\n\n    * CR.\n    * Induction failure or 1st relapse with \\\u003C 10% blasts in the marrow.\n  * Chronic Myelogenous Leukemia (CML) in second chronic phase after accelerated or blast crisis.\n  * Chronic Myelomonocytic Leukemia (CMML)\n  * Hodgkin's Lymphoma that is relapsed or refractory\n* Age \\> or equal to 18 years, \\\u003C or equal to 70yrs\n* KPS \\> or equal to 80 for Flu\u002FCy\u002FThio\u002FTBI; KPS \\> 60 for Flu\u002FTreo\u002FTBI\n* Patients without a suitable HLA-matched related or unrelated donor\n* Patient with the following CB units:\n\n  * At least two 4-8\u002F8 HLA high resolution matched CB units. Both must have a cell dose of 1.5x107 TNC\u002Fkg each and 1.5x105 CD34+\u002Fkg\n  * A minimum of 1 CB unit as back up.\n* Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia, and CNS lymphoma including standard intrathecal chemotherapy and\u002For radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Subjects must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for 12 months after the last dose of abatacept.\n* A woman is considered to be of childbearing potential if she is \\\u003C 60 years old, postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, as defined below:\n\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 12 months after the last dose of abatacept. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of abatacept.\n  * 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 patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Patients with inadequate Organ Function as defined by:\n\n  * Creatinine clearance \\\u003C 50ml\u002Fmin\n  * Bilirubin \\> 2X institutional upper limit of normal unless Gilbert syndrome\n  * AST (SGOT) \\> 3X institutional upper limit of normal\n  * ALT (SGPT) \\> 3X institutional upper limit of normal\n  * Pulmonary function: DLCOc \\\u003C 60% normal\n  * Cardiac: left ventricular ejection fraction \\\u003C 50\n* Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.\n* Presence of donor-specific antibodies against chosen graft source.\n* Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) \\> 5.\n* Prior autologous or allogenic stem cell transplant within the preceding 12 months.","65 Years",{"count":54,"type":22},20,[25],"The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT.\n\nParticipants will:\n\n* Partake in exams, tests, and procedures as part of usual cancer care.\n* Partake in conditioning, which is the treatment that is given before a transplant.\n* Have a cord blood transplant.\n* Partake in radiation following the transplant.",[58,59,60,61,62,63,64,65],"Acute Myelogenous Leukemia","Acute Lymphatic Leukemia","Chronic Myelogenous Leukemia","Myelodysplastic Syndromes","Myelodysplastic Syndrome Other","Chronic Myelomonocytic Leukemia","Lymphoma","Hodgkin Lymphoma",[67,68,69,70],"Chronic Myelomonocytic Lymphoma","Umbilical Cord Blood Transplant","Double Umbilical Cord Transplant","Cord blood","2025-06-02",{"date":73,"type":36},"2025-06-04",{"date":75,"type":36},"2025-02-25",{"date":77,"type":22},"2028-10-31",{"name":42,"class":43},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":19,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100293793","phase-1-inotuzumab-ozogamicin-post-transplant-for-acute-lymphocytic-leukemia-100293793","NCT03104491","Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia","Inclusion Criteria:\n\nPhase 1 Inclusion Criteria\n\n* Diagnosis of CD22-positive Acute Lymphoblastic Leukemia\n* Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia\n* Patients who are between T+40 and T+100 after allogeneic transplantation. Patients must receive their first dose of inotuzumab at or before T+100.\n* Patients who have\u002Fare either:\n\n  * Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation\n\n    ---Pre- or Post-Transplant Minimal Residual Disease defined by:\n\n    ----Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication.\n  * In second or third complete remission at the time of allogeneic transplantation\n  * Treated with reduced intensity regimens or non-myeloablative conditioning regimens\n  * Lymphoid blast crisis of CML\n  * Are relapsed or refractory to at least 1 line of chemotherapy\n  * Philadelphia-like ALL\n* Patients who have evidence of donor chimerism after allogeneic transplantation.\n* ECOG Performance status \\\u003C 2\n* Participants must have ANC \\> 1,000\u002FµL for 3 days and platelet transfusion independence as defined as a platelet count \\> 50,000\u002FµL for 7 days.\n* Able to adhere to the study visit schedule and other protocol requirements.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nPhase 2 Inclusion Criteria\n\n* Diagnosis of CD22-positive Acute Lymphoblastic Leukemia\n* Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia\n* Patients who are between T+40 and T+100 after allogeneic transplantation\n* Patients who have\u002Fare either:\n\n  * Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation\n\n    ---Post-Transplant Minimal Residual Disease defined by:\n\n    ----Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication.\n  * In second or third complete remission at the time of allogeneic transplantation\n  * Treated with reduced intensity regimens as defined per institutional standard of practice\n  * Lymphoid blast crisis of CML\n  * Are relapsed or refractory to at least 1 line of chemotherapy\n  * Philadelphia-like ALL\n* Patients who have \\> 80% donor chimerism after allogeneic transplantation.\n* Philadelphia chromosome positive ALL must have failed at least 1 TKI\n* ECOG Performance status \\\u003C 1\n* pre-transplant evaluation, see 10.1.1\n* Participants must have ANC \\> 1,000\u002FµL for 3 days and platelet transfusion independence as defined as a platelet count \\> 50,000\u002FµL for 7 days.\n* Able to adhere to the study visit schedule and other protocol requirements.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nPhase 1 and 2 Exclusion Criteria:\n\n* Patients with clinical evidence of disease progression prior to enrollment\n* Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)\n* Patients with inadequate organ function as defined by:\n\n  * Creatinine clearance \\\u003C 30ml\u002Fmin\n  * Bilirubin \\> 2X institutional upper limit of normal\n  * AST (SGOT) \\> 2X institutional upper limit of normal\n  * ALT (SGPT) \\> 2X institutional upper limit of normal\n* GVHD grade III or IV (for patients with a prior allogeneic transplant).\n* Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)\n* History of VOD\n* Use of concomitant TKI or sirolimus\n* Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)\n* Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women are excluded from this study because inotuzumab ozogamicin may be associated 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 inotuzumab ozogamicin, breastfeeding should be discontinued if the mother is treated with inotuzumab ozogamicin. These potential risks may also apply to other agents used in this study.\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n* Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n* Participation in any other investigational drug study or had exposure to any other investigational agent, device, or procedure, within 21 days (or 5 half-lives, whichever is greater)\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds","16 Years",{"count":87,"type":22},44,[89,25],"PHASE1","This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects.\n\nThe Phase II portion of this study is to see what side effects are seen with medication after transplant.\n\nInotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed\u002Frefractory acute lymphocytic leukemia (ALL).\n\nInotuzumab ozogamicin is considered experimental in this study.",[92],"Acute Lymphocytic Leukemia",[94,95],"allogeneic hematopoietic stem cell transplantation","donor chimerism",{"date":97,"type":36},"2025-06-05",{"date":99,"type":36},"2017-07-31",{"date":101,"type":22},"2027-05",{"name":42,"class":43},7,""]