OncoMatch/Clinical Trials/NCT06129734
Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant
Is NCT06129734 recruiting? Yes, currently enrolling (May 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
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: allogeneic stem cell transplant — planned or received
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: HMA/VEN therapy
Prior disease progression on HMA/VEN therapy, single agent venetoclax.
Cannot have received: FLT3-ITD targeting agents
Other planned post-transplant maintenance therapy, such as FLT3-ITD targeting agents, as determined by the treating physician
Lab requirements
Blood counts
Bone marrow myeloblasts <5% at pre-transplant bone marrow aspirate and biopsy with no circulating blasts; Successful engraftment defined by ANC ≥500/ul and platelet count of ≥50,000/uL sustained for at least three consecutive days
Kidney function
Creatinine clearance (CrCl) > 30 ml/min
Liver function
Total bilirubin < 2.0 mg/dL (exception: Gilbert's syndrome, direct bilirubin < 2 × ULN)
Bone marrow myeloblasts <5% at pre-transplant bone marrow aspirate and biopsy with no circulating blasts. 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. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University Hospitals Seidman Cancer, Case Comprehensive Cancer Center · Cleveland, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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