[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Benjamin Tomlinson\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100376913","early-phase-1-5-azacitidine-and-decitabine-epigenetic-therapy-for-myeloid-malignancies-100376913",false,"NCT04187703","5-Azacitidine and Decitabine Epigenetic Therapy for Myeloid Malignancies","Proof-Of-Concept Study of Metabolically Optimized, Non-Cytotoxic 5-Azacitidine and Decitabine Epigenetic Therapy for Myeloid Malignancies","Inclusion Criteria:\n\n* Participants must have MDS or MDS\u002Fmyeloproliferative overlap disorder with potential sensitivity to HMA therapy, defined as prior published evidence of response to HMA\n\n  * Myelodysplastic Syndromes:\n\n    * As classified by hematopathology review of WHO categories, myelodysplastic\u002Fmyeloproliferative neoplasm unclassifiable, refractory anemia with ring sideroblasts and thrombocytosis, refractory cytopenia with unilineage dysplasia (RCUD), refractory anemia with ring sideroblasts (RARS), refractory cytopenia with multi-lineage dysplasia (RCMD), refractory anemia with excess blasts (RAEB), myelodysplastic syndrome with isolated del(5q), myelodysplastic syndrome unclassifiable (MDS-U).\n    * Participant with MDS who are IPSS-R high and very high risk or IPSS intermediate 2 risk and higher are excluded given proven overall survival benefit in higher risk MDS from AZA-001 with this treatment\n  * Myelodysplastic\u002Fmyeloproliferative neoplasm overlap disorders ---MDS\u002FMPN crossover syndromes with limited evidence of extramedullary hematopoiesis (may not have palpable splenomegaly) and reticulin fibrosis of grade 1 or less without evidence of progression to accelerated phase. These may include but may not be limited to RARS-T, CMML, Atypical CML (BCR-ABL negative), and MDS\u002FMPN NOS\n* Indication for HMA therapy: Symptomatic anemia OR thrombocytopenia with a platelet count of \\\u003C100 x 109\u002FL OR transfusion dependence for red-cells OR transfusion dependence for platelets OR absolute neutrophil count \\\u003C 1.0 x 109\u002FL\n\n  --Participants with lower risk MDS must have must have failed or have contraindications to available therapies (e.g. lenalidomide, epoetin if indicated for symptomatic anemia and\u002For transfusion dependence of red cells) known to be effective for treatment of their disease\n* Participants must have performance status of 60% or greater by Karnofsky Performance Status (KPS)\n* Must have adequate end organ function defined as:\n\n  * AST and ALT \\\u003C 3× the upper limit of normal (ULN)\n  * Bilirubin ≤ 1.5× the ULN. If elevated bilirubin is due to impaired conjugation (e.g Gilbert's disease or concomitant medication) or disease related hemolysis, then direct bilirubin ≤ 1.5× the ULN\n  * As azacitidine and decitabine have little renal metabolism, and have proven safety even in dialysis participants, renal function is not an inclusion or exclusion criteria\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures.\n\nExclusion Criteria:\n\n* MDS with IPSS-R high or very high risk, or IPSS intermediate-2 or high risk disease\n* Prior Treatment with azacitidine, decitabine or investigational HMA therapy with overlapping mechanism of action (e.g. guadecitibine)\n* No other disease directed therapy, save for hydroxyurea, including experimental or investigational drug therapy for 14 days prior to study entry.\n* Toxicity (grade 2 or higher) from prior therapies including chemotherapy, targeted therapy, immunotherapy, experimental therapy, radiation or surgery must be resolved to grade 1 or less.\n* Currently pregnant or breast-feeding. Females of child bearing (FOCBP) potential must have negative serum pregnancy test within 72 hours from treatment start. (NOTE: FOCBP is any biologic female, regardless of sexual or gender orientation, having undergone tubal ligation, or remaining celibate by choice, who has not undergone a documented hysterectomy or bilateral oophorectomy or has had a menses any time in the preceding 12 months (therefore not naturally post-menopausal for \\> 12 months)\n* Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to:\n\n  * Ongoing or active infection. As participants with MDS and MDS\u002FMPNs are prone to infections, if participants are actively being treated with appropriate antibiotics or antifungal therapy with clinical evidence of infection control, then they will be considered eligible for study.\n  * Uncontrolled concurrent malignancy\n  * Congestive heart failure of NYHA class III\u002FIV. Participants with compensated heart failure are permitted.\n  * Unstable angina pectoris\n  * New or unstable cardiac arrhythmia. Stable or controlled arrhythmias are permitted\n  * Decompensated liver cirrhosis (Child-Pugh score ≥12 or a MELD score ≥21)\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n  * Any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the participant or impair the assessment of study results.\n* WOCBP and males that are unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control; abstinence, condom) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately\n* Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a female with child-bearing potential, beginning at the screening visit and continuing until 4 weeks after taking the last dose of 5AZA-alt-DEC.\n* Participants with known active HIV infection, as this will further increase the risk for opportunistic infections. However, participants with chronic HIV with undetectable viral load by PCR, without opportunistic infection, and on a stable regimen of antiretroviral therapy would be eligible.\n* Known allergy or hypersensitivity to any component of azacitidine or decitabine formulations","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Another term for myelodysplastic syndrome is bone marrow failure. The bone marrow is where components of blood such as red cells, platelets and white cells are made. In bone marrow failure, the ability for bone marrow to make these cells is decreased. In myelodysplastic syndrome, this decreased bone marrow function is believed to result from abnormalities that prevent the normal maturation process by which bone marrow cells develop into red blood cells, white blood cells and platelets. In myelodysplastic syndrome, these abnormal bone marrow cells occupy space in the bone marrow and prevent the function of remaining normal bone marrow cells.\n\nOne approach to treating the abnormal growth of immature cells is to give chemotherapy which damages DNA within these cells and causes their death. Unfortunately, such therapy has side-effects, since even normal cells can be affected by the treatment. Both 5-azacitidine (5AZA) and decitabine (DEC) are FDA-approved to treat MDS. In this study, 5AZA and DEC will be administered using an alternating low doses schedule in an attempt to overcome the known mechanisms of resistance to the administration of 5AZA or DEC as single agents caused by automatic adaptive shifts in DNA metabolism.",[26,27],"Myelodysplastic Syndromes","MDS\u002FMPN Crossover Syndromes","RECRUITING","2026-05-15",{"date":31,"type":32},"2026-05-18","ACTUAL",{"date":34,"type":32},"2020-11-16",{"date":36,"type":20},"2027-12-01",{"name":38,"class":39},"Benjamin Tomlinson","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":5},"100526053","phase-1-decitabine-and-venetoclax-treatment-as-maintenance-therapy-in-patients-post-allograft-stem-cell-transplant-100526053","NCT06129734","Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant","Phase 1B\u002F2A Study of Weekly Decitabine and Venetoclax Treatment as Maintenance Therapy in High-Risk Myeloid Malignancy Patients Post Allograft Stem Cell Transplant","Inclusion Criteria:\n\n* Diagnosis of Acute myeloid leukemia, MDS, MDS\u002FAML with high-risk for post-transplant relapse identified by:\n\n  * Very high or high risk by CIBMTR Disease Risk Index (DRI) and\u002For adverse risk by ICC 2022 criteria and\u002For MDS\u002FAML by ICC 2022 criteria.\n  * Very high or high risk by CIBMTR DRI and\u002For by IPSS-M \\> 0.510-12 and\u002For MDS\u002FAML by ICC 2022 criteria.\n* Bone marrow myeloblasts \\\u003C5% at pre-transplant bone marrow aspirate and biopsy with no circulating blasts.\n* Participants must be planned for or have received alloSCT. Any conditioning regimen intensity or graft source (MRD\u002FMUD\u002FHaplo\u002FUCB) is permitted.\n* Participants must be 18 years of age or older.\n* Total bilirubin \\\u003C 2.0 mg\u002FdL (with the exception of participants with known Gilbert's syndrome, who should have direct bilirubin \\\u003C 2 × ULN).\n* Creatinine clearance (CrCl) \\> 30 ml\u002Fmin.\n* ECOG 0-1 performance status.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures.\n* Participants may enroll prior to or after alloSCT. Participants should enroll no later than post transplant day 40, and the the following post-AlloHSCT inclusion criteria must be met in order to initiate the maintenance study treatment:\n\n  * Successful engraftment defined by absolute neutrophil count (ANC) of ≥500\u002Ful and platelet count of ≥50,000\u002FuL sustained for at least three consecutive days.\n  * These criteria for engraftment should be met on or before Day +50.\n  * No active infection\n  * No GVHD ≥ overall grade II (Grade 1 GVHD of the skin acceptable).\n  * Participants must continue to meet additional inclusion criteria\n  * \\\u003C5% myeloblasts in a bone marrow aspirate with spicules, that is to be obtained, if all the above inclusion criteria are satisfied.\n\nExclusion Criteria:\n\n* Prior disease progression on HMA\u002FVEN therapy, single agent venetoclax.\n* Other planned post-transplant maintenance therapy, such as FLT3-ITD targeting agents, as determined by the treating physician\n* Currently pregnant or breast-feeding. Females of childbearing (FOCBP) potential must have negative serum pregnancy test within 72 hours from treatment start. (NOTE: FOCBP is any biologic female, regardless of sexual or gender orientation, having undergone tubal ligation, or remaining celibate by choice, who has not undergone a documented hysterectomy or bilateral oophorectomy or has had a menses any time in the preceding 12 months (therefore not naturally post-menopausal for \\> 12 months)\n* Uncontrolled comorbid illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to:\n\n  * Active infection\n  * Uncontrolled concurrent malignancy\n  * Congestive heart failure of NYHA class III\u002FIV. Participants with compensated heart failure are permitted.\n  * Unstable angina pectoris\n  * New or unstable cardiac arrhythmia. Stable or controlled arrhythmias are permitted\n  * Decompensated liver cirrhosis (Child-Pugh score ≥12 or a MELD score ≥21\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n  * Any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the participants or impair the assessment of study results.\n* FOCBP and males that are unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control; abstinence, condom) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, they should inform the treating physician immediately\n* Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a female with child-bearing potential, beginning at the screening visit and continuing until 4 weeks after taking the last dose of decitabine\u002Fvenetoclax.\n* Participants with known active HIV infection, as this will further increase the risk for opportunistic infections. However, participants with chronic HIV with undetectable viral load by PCR, without opportunistic infection, and on a stable regimen of antiretroviral therapy would be eligible.\n* Known allergy or hypersensitivity to any component of decitabine\u002Fvenetoclax",{"count":19,"type":20},[50,51],"PHASE1","PHASE2","The goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. The main question it aims to answer is whether or not providing a new, gentler way of administering chemotherapy will help control leftover cancer with minimal side effects. This treatment involves decitabine and venetoclax. Participants will receive standard post-transplant care. Participants will be administered decitabine once per week with normal transplant follow up visits, and then will take a venetoclax pill about 6 to 8 hours later. Participants will meet their study team at the beginning, midway, and at the end of the trial to receive bone marrow testing. Participants will receive treatment until either one year of therapy, relapse, or recurrent dose limiting toxicity (DLT) despite dose reduction.",[54,55],"Myeloid Malignancy","Acute Myeloid Leukemia",[57],"Allograft Stem Cell Transplant","2026-04-22",{"date":60,"type":32},"2026-04-27",{"date":62,"type":32},"2025-07-28",{"date":64,"type":20},"2027-07",{"name":38,"class":39},""]