Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamin Tomlinson

About this trial

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.

Eligibility criteria

Qualifiers

Very high or high risk by CIBMTR Disease Risk Index (DRI) and/or adverse risk by ICC 2022 criteria and/or MDS/AML by ICC 2022 criteria.

Very high or high risk by CIBMTR DRI and/or by IPSS-M > 0.510-12 and/or MDS/AML by ICC 2022 criteria.

Bone marrow myeloblasts <5% at pre-transplant bone marrow aspirate and biopsy with no circulating blasts.

Participants must be planned for or have received alloSCT. Any conditioning regimen intensity or graft source (MRD/MUD/Haplo/UCB) is permitted.

Disqualifiers

Prior disease progression on HMA/VEN therapy, single agent venetoclax.

Other planned post-transplant maintenance therapy, such as FLT3-ITD targeting agents, as determined by the treating physician

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)

Active infection

Trial design

Treatments tested in this trial

  • Venetoclax
  • Decitabine

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Benjamin Tomlinson

Lead sponsor

Case Comprehensive Cancer Center

Sponsor institution