[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sawa Ito, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100636402","phase-1-thiotepa-based-conditioning-regimen-with-de-escalated-post-graft-cyclophosphamide-for-allogeneic-stem-cell-transplantation-in-hematologic-malignancies-100636402",false,"NCT07565220","Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies","Phase 1 Trial of Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies","Inclusion Criteria:\n\n1. Patients must be considered appropriate candidates for either the low- or high-intensity conditioning regimen for allogeneic hematopoietic stem cell transplantation based on the following age-related criteria:\n\n   1. Age 50-70 years old or\n   2. Age 18-49 and unfit for a conventional myeloablative conditioning regimen per the treating physician\n2. Patients have one of the following diagnoses:\n\n   1. Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology).\n   2. Acute myeloid leukemia (AML) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology) with or without hematologic recovery.\n   3. Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia or chronic myeloid leukemia with blast crisis) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology) with or without hematologic recovery.\n   4. Myelodysplastic syndrome (MDS) with a history of excess blasts, with \\>5% marrow blasts by morphology after receiving at least one cycle of treatment, including but not limited to hypomethylating agent, BCL-2 inhibitor, cytoreductive chemotherapy.\n   5. High-risk myeloproliferative neoplasm (MPN) with no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.\n3. Patients with an 8\u002F8 HLA-matched (HLA-A, B, C, DRB1) related or unrelated donor capable of donating peripheral blood stem cells (PBSC)\n4. Provision of signed and dated informed consent form\n5. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and until tacrolimus or other immunosuppressive therapy for GVHD is discontinued (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n6. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n\n   1. 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). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they meet any of the following criteria.\n\nFor high-intensity regimen:\n\n1. Poor performance status with Karnofsky Score \\\u003C70%\n2. Center for International Blood and Marrow Transplant Research (CIBMTR) hematopoietic cell transplant co-morbidity index (HCT-CI) score \\>5\n3. Patients with active central nervous system (CNS) involvement refractory to intrathecal chemotherapy and\u002For standard craniospinal radiation.\n4. Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.\n5. Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.\n6. Patients with organ dysfunction, including:\n\n   1. Renal insufficiency creatinine clearance \\\u003C45 ml\u002Fmin\u002F1.72m2 measured by 24-hr urine specimen\n   2. Left ventricular ejection fraction \\\u003C45%\n   3. Diffusing capacity of the lung for carbon monoxide (DLCO) corrected \\\u003C50% or FEV1 \\\u003C50%\n   4. Liver function abnormality: total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \\>5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist considers that alloSCT is contraindicated, the patient will be excluded from the protocol.\n7. Patients who have received previous allogeneic transplantation.\n8. Patients with a life expectancy \\\u003C12 months due to co-existing diseases other than hematologic malignancies.\n9. Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.\n10. Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).\n11. Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI.\n\nFor low-intensity regimen\n\n1. Poor performance status with Karnofsky Score \\\u003C60%\n2. Patients with active CNS involvement refractory to intrathecal chemotherapy and\u002For standard craniospinal radiation.\n3. Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.\n4. Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.\n5. Patients with organ dysfunction, including:\n\n   1. Renal insufficiency creatinine clearance \\\u003C40 ml\u002Fmin\u002F1.72m2 measured by 24-hr urine specimen\n   2. Left ventricular ejection fraction \\\u003C40%\n   3. DLCO corrected\\\u003C 50% or FEV1\\\u003C50%\n   4. Liver function abnormality: total bilirubin, AST, ALT\\>5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist considers that alloSCT is contraindicated, the patient will be excluded from the protocol.\n6. Patients who have received previous allogeneic transplantation.\n7. Patients with a life expectancy \\\u003C12 months from co-existing disease other than hematologic malignancies\n8. Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.\n9. Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).\n10. Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI.","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).",[26,27,28,29,30],"Acute Lymphocytic Leukemia (ALL)","Acute Myeloid Leukemia (AML)","Acute Leukemia","Myelodysplastic Syndrome(MDS)","Myeloproliferative Neoplasm (MPN)",[32,33,34],"allogeneic hematopoietic stem cell transplantation","HLA","graft-versus-host disease (GVHD)","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":20},"2026-08-01",{"date":43,"type":20},"2030-11-01",{"name":45,"class":46},"Sawa Ito, MD","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100556793","phase-2-interferon--ifn--with-donor-leukocyte-infusion-to-treat-relapsed-acute-myeloid-leukemia-and-myelodysplastic-syndromes-post-allogeneic-hematopoietic-stem-cell-transplantation-100556793","NCT06529731","Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation","A Phase 2 Trial of Interferon-γ (IFN-γ) in Combination With Donor Leukocyte Infusion (DLI) to Treat Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) After Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Recipients of an alloSCT for AML or MDS from a minimally 8\u002F8 HLA-matched donor\n3. AML\u002FMDS relapsed post-alloSCT with measurable residual disease defined by either of the following criteria:\n\n   1. At least 5% or more myeloblasts based on bone marrow biopsy morphology by pathologist review. Abnormal myeloblasts cannot not exceed 30% overall 36\n   2. At least 0.1% of abnormal myeloblasts with a leukemia-associated immunophenotype (LAIP) by multiparameter flow cytometry. The abnormal cells with LAIP should not exceed 30% of nucleated cells.\n   3. Recurrent or persistent cytogenetic abnormalities detectable by FISH or karyotype analysis.\n   4. For patients with mutant NPM1, at least 1,000 mutant transcript copies per 106 ABL or equivalent housekeeping transcripts in bone marrow by qPCR or dPCR\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2\n5. A DLI is available, or the donor is available and agrees to undergo apheresis to collect lymphocytes for infusion\n6. If salvage therapy for post-alloSCT relapse was received, the therapy is limited to 1 line of the following:\n\n   1. For hypomethylating agents, venetoclax, and targeted therapies (e.g., tyrosine kinase inhibitors, IDH1\u002FIDH2 inhibitors, or FLT3 inhibitors), the last dose must be \\> 2 week prior to the initiation of IFN-γ\n   2. For cytotoxic chemotherapy agents, the last dose must be \\>2 weeks prior to start of treatment for the present study\n   3. For investigational agents, the last dose must be ≥ 4 weeks or 5 half-lives (whichever is longer) prior to the start of treatment for the present study\n7. Provision of signed and dated informed consent form\n8. Stated willingness to comply with all study procedures and availability for the duration of the study\n9. For female subject, who is \\\u003C 55 years old without hysterectomy, oophorectomy or documented menopause, willingness to use two forms of contraception including one form of highly effective contraception (i.e., long-acting reversible contraception, oral contraceptive pills) for the duration of the study\n10. For male subject, willingness to use highly effective contraception methods including male condoms by male subject and one form of highly effective contraception by his female partner (i.e., long-acting reversible contraception, oral contraceptive pills) for the duration of the study\n\nExclusion Criteria:\n\n1. Primary engraftment failure after alloSCT\n2. Grade 3 or 4 aGVHD per Mount Sinai Acute GVHD International Consortium (MAGIC) at the time of planned enrollment\n3. History of grade 4 aGVHD per the MAGIC criteria\n4. Moderate or severe cGVHD per NIH Consensus Criteria at time of planned enrollment\n5. Any systemic immunosuppressive medications taken within 2 weeks before the enrollment\n6. Grade 3 or higher non-hematologic toxicity related to any prior therapy at the time of enrollment\n7. A contraindication to receive IFN-γ including a known hypersensitivity to IFN-γ, E. coli derived products or any other component of the product\n8. Positive pregnancy test or currently breastfeeding on Day 1 of study treatment 37\n9. Active cardiac arrhythmia not controlled by medical management or current NYHA class II or higher congestive heart failure within 2 months of enrollment unless it was due to a tachyarrhythmia which is under control at the time of enrollment\n10. Active ischemic heart disease not controlled with medications within 2 months of enrollment\n11. Acute or chronic pulmonary disease requiring continuous oxygen treatment\n12. Seizure disorder not controlled by medications within 2 months of enrollment\n13. AST or ALT \\> 5x ULN or total bilirubin \\>3x ULN at time of enrollment\n14. Renal function CrCl \\\u003C30 mL\u002Fmin at time of enrollment using modified Cockcroft-Gault formula\n15. Body surface area ≤ 1.5 m2 or ≥ 2.5 m2 so as to minimize variation in IFN-γ exposure based on differences in body surface area",{"count":56,"type":20},45,[58],"PHASE2","This phase 2 study aims to confirm the efficacy seen in the prior phase 1 trial, and further contribute to this effort through the collection of leukemia cells pre- and post- in vivo IFN-γ therapy. As in the previously conducted phase 1 trial, this trial will test whether leukemia blasts were responsive to IFN-γ in vitro and in vivo, with single-cell RNA sequencing (scRNAseq) conducted to understand the transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.",[61,62],"Acute Myeloid Leukemia","Myelodysplastic Syndromes",[64,65,66],"interferon-γ (IFN-γ)","donor leukocyte infusion (DLI)","allogeneic hematopoietic stem cell transplantation (alloSCT)","2025-10-10",{"date":69,"type":39},"2025-10-14",{"date":71,"type":39},"2024-09-23",{"date":73,"type":20},"2027-10-31",{"name":45,"class":46},3,""]