OncoMatch/Clinical Trials/NCT06129734
Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant
Official title: Phase 1B/2A Study of Weekly Decitabine and Venetoclax Treatment as Maintenance Therapy in High-Risk Myeloid Malignancy Patients Post Allograft Stem Cell Transplant
Is NCT06129734 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including Venetoclax and Decitabine for myeloid malignancy.
Treatment: Venetoclax · Decitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: allogeneic stem cell transplant
Participants must be planned for or have received alloSCT. Any conditioning regimen intensity or graft source (MRD/MUD/Haplo/UCB) is permitted.
Cannot have received: post-transplant maintenance therapy targeting FLT3-ITD
Other planned post-transplant maintenance therapy, such as FLT3-ITD targeting agents, as determined by the treating physician
Lab requirements
Blood counts
Successful engraftment defined by absolute neutrophil count (ANC) of ≥500/ul and platelet count of ≥50,000/uL sustained for at least three consecutive days; <5% myeloblasts in a bone marrow aspirate with spicules
Kidney function
Creatinine clearance (CrCl) > 30 ml/min
Liver function
Total bilirubin < 2.0 mg/dL (with the exception of participants with known Gilbert's syndrome, who should have direct bilirubin < 2 × ULN)
Total bilirubin < 2.0 mg/dL (with the exception of participants with known Gilbert's syndrome, who should have direct bilirubin < 2 × ULN). Creatinine clearance (CrCl) > 30 ml/min. Successful engraftment defined by absolute neutrophil count (ANC) of ≥500/ul and platelet count of ≥50,000/uL sustained for at least three consecutive days; <5% myeloblasts in a bone marrow aspirate with spicules
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center · Cleveland, Ohio
- University Hospitals Seidman Cancer, Case Comprehensive Cancer Center · Cleveland, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06129734 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior post-transplant maintenance therapy targeting FLT3-ITD disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify