[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07044544":3,"trial-entities:NCT07044544":118,"trial-summary:NCT07044544":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":53,"secondary_outcomes":58,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":74,"locations":77,"central_contacts":104,"overall_officials":111,"references":116,"see_also_links":117},"NCT07044544","IRB-300014728 (UAB 2469)","Trial of Novel Anti-leukemia Agents in Flu\u002FMel RIC Transplant for Myeloid Malignancies","A Phase I Trial to Evaluate the Safety and Efficacy of Addition of Novel Anti-leukemia Agents to Flu\u002FMel RIC Transplant for High-risk Myeloid Malignancies","RECRUITING","2027-01","2026-03","2026-03-04","2025-07-17","University of Alabama at Birmingham","OTHER",true,"The purpose of this study is to determine the safety of adding Decitabine and Venetoclax to patients undergoing reduced intensity allogenic transplantation for treatment of hematologic malignances with Fludarabine and Melphalan.","The purpose of this study is to evaluate the safety, tolerability and preliminary activity of decitabine and venetoclax as part of RIC AHSCT in patients with high-risk AML and MDS. The study will follow a standard 3+3 design commonly used in phase I studies. Dose-adjustments will be made based on the incidence of dose-limiting toxicities (DLTs). The DLT period is from the first dose of decitabine to day 28 post-transplant.\n\nCohort 1 DL1: G-CSF + Decitabine (100mg\u002Fm2 bid for 2d) Cohort 1 DL-1: G-CSF + Decitabine (50mg\u002Fm2 bid for 2d) Cohort 2 DL1: G-CSF + Decitabine + Ven (200mg\u002Fd for 7d) Cohort 2 DL2: G-CSF + Decitabine + Ven (400mg\u002Fd for 7d)",[19,20,21,22],"Myeloid Malignancy","Hematologic Malignancy","Acute Myeloid Leukemia","Myelodysplastic Syndromes",[24,25],"Leukemia","allogeneic transplant","INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},20,"ESTIMATED",[34,43,49],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","G-CSF","Granulocyte colony-stimulating factor (G-CSF) is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream.",[39,40,41,42],"Cohort 1 DL-1: G-CSF + Decitabine (50mg\u002Fm2 bid for 2d)","Cohort 1: G-CSF + Decitabine (100mg\u002Fm2 bid for 2d)","Cohort 2 DL2: G-CSF + Decitabine + Ven (400mg\u002Fd for 7d)","Cohort 2: G-CSF + Decitabine + Ven (200mg\u002Fd for 7d)",{"type":35,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Decitabine","Decitabine is a hypomethylating agent.",[39,40,41,42],[48],"Dacogen",{"type":35,"name":50,"description":51,"armGroupLabels":52},"Venetoclax","Venetoclax is a selective inhibitor of BCL-2 protein.",[41,42],[54],{"measure":55,"description":56,"timeFrame":57},"Measuring changes in dose limiting toxicities","Determine the safety of adding Decitabine and Venetoclax to patients undergoing reduced intensity allogeneic transplantation for treatment of hematologic malignances with Fludarabine and Melphalan.","Up to 28 days",[59],{"measure":60,"description":61,"timeFrame":62},"The average regimen-related toxicity","Rate of grade \\>- 4, non-hematologic toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0","At 1 year","ALL","18 Years","75 Years",false,{"inclusion":68,"exclusion":72,"raw_text":73},[69,70,71],"AML: A. Any AML with active disease (defined as ≥ 5% blasts in the marrow), with no available re-induction strategies, or further therapy is not felt to be effective by treating physician.","MDS:","MDS\u002FMPN \\>5% blasts and spleen \\\u003C 22 cm with no available pre-transplant strategies, or further therapy is not felt to be effective by treating physician. 12. Subject is willing and able to sign informed consent and abide by the protocol requirements.",[],"Inclusion Criteria:\n\n1. Adult male or female, age 18-75 years\n2. Patients must have a related or unrelated peripheral blood stem cell donor. Sibling donor must be a 6\u002F6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing, and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. Unrelated donor must the following: have Optimum: HLA-A, -B, -C, -DRB1, -DRB3\u002F4\u002F5, -DQA1, -DQB1, -DPA1 and -DPB1; Minimum: HLA-A, -B, -C, -and DRB1 matching at high resolution using DNA-based typing and be willing to donate peripheral blood stem cells and be medically eligible to donate stem cells according to National Marrow Donor Program (NMDP) criteria.\n3. A candidate for reduced intensity preparative regimen, based on age≥60, or HCT-CI of ≥4, or considered by the treating physician to have high risk for toxicity with myeloablative preparative regimen.\n4. Cardiac function: Ejection fraction \\>40%\n5. Calculated creatinine clearance greater than 50 mL\u002Fminute (using the Cockcroft-Gault formula and actual body weight).\n6. Pulmonary function: DLCO ≥50% (adjusted for hemoglobin) and FEV1≥50%\n7. Liver function: total bilirubin \\\u003C 1.5x the upper limit of normal and ALT\u002FAST \\\u003C 2.5x the upper normal limit. Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value up to \\\u003C3mg\u002Fdl.\n8. Female subjects (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two effective methods of contraception or agree to complete abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.\n9. Male subjects (even if surgically sterilized), of partners of women of childbearing potential must agree to practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant.\n10. Karnofsky performance status KPS ≥ 70 (Appendix B)\n11. Patients must have a diagnosis of one of the following:\n\n    -AML: A. Any AML with active disease (defined as ≥ 5% blasts in the marrow), with no available re-induction strategies, or further therapy is not felt to be effective by treating physician.\n\n    B. Any AML with adverse risk disease, therapy-related or secondary-AML in CR1 or beyond C. AML with intermediate risk disease that is MRD+ in CR1 or beyond D. Any AML in CR2 or beyond (regardless of MRD) E. Marrow blast percentage needs to be 20-25% and total WBC counts needs to be ≤ 25000\u002Fµl before the start of the conditioning regimen. It is acceptable to use hydroxyurea or low dose cytarabine to maintain this WBC count.\n\n    -MDS:\n\n    MDS with IPSS-M ≥ high and\u002For with ≥5% blasts in the bone marrow with no available pre-transplant strategies, or further therapy is not felt to be effective by treating physician.- MDS\u002FMPN:\n\n    -MDS\u002FMPN \\>5% blasts and spleen \\\u003C 22 cm with no available pre-transplant strategies, or further therapy is not felt to be effective by treating physician.\n12. Subject is willing and able to sign informed consent and abide by the protocol requirements.\n\nExclusion Criteria:\n\n1. Autologous hematopoietic stem cell transplant \\\u003C 3 months prior to enrollment.\n2. Previous allogeneic stem cell transplant.\n3. Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities.\n4. Known hypersensitivity to Decitabine, Venetoclax and\u002For ATG.)\n5. Pregnant and\u002For breastfeeding\n6. Evidence of HIV infection or known HIV positive serology.\n7. Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).\n8. Non-hematologic malignancy within prior three (3) years, with the exception of squamous cell or basal cell skin carcinoma. Patients with prior malignancies except resected localized non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed as long as it is in remission. Cancer treated with curative intent \\\u003C 5 years previously must be reviewed and approved by the PI as long as it is in remission.\n9. Participation in another clinical study with an investigational product during the last 28 days.\n10. Patients with documented cirrhosis (will need imaging +\u002F- biopsy confirmation, hepatology consult recommended)",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":13,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":101},"Birmingham","Alabama","35294","United States",[84,88,91,93,95,97,99],{"name":85,"role":86,"email":87},"Margaret Thomas, MPH","CONTACT","margaretannthomas@uabmc.edu",{"name":89,"role":90},"Zaid Al-Kadhimi, MD","SUB_INVESTIGATOR",{"name":92,"role":90},"Ravi Bhatia, MD",{"name":94,"role":90},"Antonio Di Stasi, MD",{"name":96,"role":90},"Manuel Espinoza-Gutarra, MD",{"name":98,"role":90},"Donna Salzman, MD",{"name":100,"role":90},"Lauren Shea, MD",{"lat":102,"lon":103},33.52066,-86.80249,[105,109],{"name":106,"role":86,"phone":107,"email":108},"Omer Jamy, MD","(205) 934-4793","omerjamy@uabmc.edu",{"name":110,"role":86,"email":87},"Margaret A Thomas, MPH",[112],{"name":113,"affiliation":114,"role":115},"Omer A Jamy, MD","The University of Alabama at Birmingham","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":119,"biomarkers":122},[21,120,121],"Miller-Dieker Syndrome","Myelodysplastic Syndrome",[123],"MBD5 wt Allele",{"nct_id":4,"found":15,"summary":125,"prompt_version":135},{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This study is an interventional trial designed to evaluate safety and preliminary activity. It will follow a 3+3 design, commonly used in early-phase studies, with dose adjustments based on side effects.","completed","Trial of Decitabine and Venetoclax with Transplant for Myeloid Malignancies","This study is testing the safety of adding two drugs, Decitabine and Venetoclax, to a reduced intensity transplant (using Fludarabine and Melphalan) for people with certain blood cancers like Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). Researchers want to see if these drugs can be safely given together with the transplant. The study will enroll about 20 participants aged 18 to 75 who have a suitable stem cell donor. The main goal is to measure any serious side effects within the first 28 days after transplant. The current status of this study is unclear.","The primary endpoint for measuring dose-limiting toxicities is up to 28 days after transplant.",95,"Not specified in the trial record.","Not stated in the trial record.",[44,50],"v2"]