[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelodysplastic-syndromemds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelodysplastic-syndromemds":29},{"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":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":47},"100558216","phase-1-a-phase-1b2a-trial-of-nadunolimab-in-combination-with-azacitidine-withwithout-venetoclax-in-patients-with-myelodysplastic-syndrome-mds-and-acute-myelogenous-leukemia-aml-100558216","NCT06548230","A Phase 1B\u002F2A Trial of NADUNOLIMAB in Combination With Azacitidine (With\u002FWithout Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)","Inclusion Criteria:\n\n1. Diagnosis\n\n   * Arm 1: Diagnosis of MDS intermediate\u002Fhigh\u002Fvery high risk by Revised International Prognostic Scoring System (IPSS-R), Untreated or up to 2 prior treatments.\n   * Arm 2: Diagnosis of relapsed\u002Frefractory AML (per European Leukemia Network 2022) \\[26\\] receiving treatment as salvage 1-2. MDS or CMML treated with hypomethylating agent (HMA) therapies who progress to AML and have no available better therapies or are not candidates for available therapies, will be eligible at the time of progression to AML.\n2. Patients aged ≥18 years\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2\n4. Temporary prior measures such as apheresis, limited dose cytarabine or use of hydrea while eligibility work-up is being performed are allowed and not counted as a prior salvage\n5. In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of protocol therapy will be at least 2 weeks or at least 5 half-lives (whichever is shorter). The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document.\n6. The toxicity from prior therapy should have resolved to Grade ≤1, however alopecia and sensory neuropathy Grade ≤2 not constituting a safety risk based on investigators judgement is acceptable.\n7. The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal (IT) therapy for patients with controlled CNS leukemia at the discretion of the PI. (2) Use of 1-2 doses of cytarabine (up to 1.5 g\u002Fm2 each dose) for patients with rapidly proliferative disease is allowed up to 7 days before the start of study therapy (7 days washout). Use of hydroxyurea for patients with rapidly proliferative disease is allowed on study and before the start of study therapy and will not require a washout. These medications will be recorded in the case-report form.\n8. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS disease is permitted. Patients with a known history of CNS disease must have been treated with CNS directed therapy, have at least 2 consecutive LPs with no evidence of CNS leukemia, and must be clinically stable for at least 4 weeks prior to enrollment and have no ongoing neurological symptoms that in the opinion of the treating physician are related to the CNS disease\n9. Serum biochemical values with the following limits:\n\n   1. Patients must have adequate renal function as demonstrated by a creatinine clearance (CrCl) ≥ 40 mL\u002Fmin calculated by either the Cockcroft-Gault formula, Modification of Diet in Renal Disease (MDRD) eGFR or measured by 24 hours' urine collection. For patients with BMI \\>23, Adjusted body weight and not Ideal Body Weight is the recommended parameter.\n   2. Direct bilirubin \\\u003C1.5 x ULN unless considered due to Gilbert's syndrome\n   3. Aspartate aminotransferase or alanine aminotransferase ≤2.0 x ULN (aspartate aminotransferase or alanine aminotransferase ≤3.0 x ULN if deemed related to leukemia by the treating physician)\n10. White blood cell count \\\u003C10 x 109\u002FL. Hydroxyurea may be used to reduce the WBC count to \\\u003C 10x109\u002FL.\n11. Ability to understand and provide signed informed consent.\n12. Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment\n13. Women of childbearing potential must agree to use an adequate method of contraception during the study and until 4 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment.\n\nExclusion Criteria:\n\n1. Patients with any other known concurrent severe and\u002For uncontrolled medical condition including but not limited to diabetes, cardiovascular disease including hypertension, renal disease, or active uncontrolled infection, which could compromise participation in the study.\n2. Patients on active antineoplastic or radiation therapy for a concurrent malignancy at the time of screening. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is allowed.\n3. Prior organ transplantation including allogenic stem-cell transplantation within 3 months prior to planned enrollment, active graft versus host disease (GVHD) \\>Grade 1 or requiring transplant-related immunosuppression with the exception of low dose cyclosporine and tacrolimus.\n4. Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia.\n5. Patients with a known HIV infection that is not well controlled (i.e. any detectable circulating viral load) at the time of enrollment.\n6. Patients with known positive hepatitis B or C infection by serology, with the exception of those with an undetectable viral load within 3 months (Hepatitis B or C testing is not required prior to study entry). Subjects with serologic evidence of prior vaccination to HBV \\[i.e., HBs Ag-, and anti-HBs+\\] may participate.\n7. Patients who have had any major surgical procedure within 14 days of Day 1.\n8. Other severe acute or chronic medical conditions that is active and not well controlled including colitis, inflammatory bowel disease, or psychiatric conditions including active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n9. Active and uncontrolled disease (active infection requiring systemic therapy or fever likely secondary to infection within prior 48 hours): prophylactic antibiotics or prolonged course of IV antibiotics for controlled infection are allowed, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure NYHA class III\u002FIV, clinically significant and uncontrolled arrhythmia, as judged by the treating physician.\n10. Requirement to use anti-TNF drugs (infliximab, etanercept, adalimumab, certolizumab, golimumab).\n11. Patients unwilling or unable to comply with the protocol.\n12. Live vaccination within 28 days from start of therapy",{"count":55,"type":20},40,[23,57],"PHASE2","To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem\u002Fprogenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.",[29,60],"Acute Myelogenous Leukemia (AML)","2026-03-05",{"date":63,"type":39},"2026-03-09",{"date":65,"type":39},"2025-03-05",{"date":67,"type":20},"2029-12-01",{"name":69,"class":46},"M.D. Anderson Cancer Center"]