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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 28, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

July 31, 2027

Conditions
Myeloid MalignancyAcute Myeloid Leukemia
Interventions
DRUG

Venetoclax

Venetoclax is a BCL2 inhibitor. It is administered at low doses and used in combination with other hypomethylating agents such as decitabine to manage participants with acute myeloid lymphoma who have undergone stem cell transplant. Participants will initiate therapy with decitabine that will be followed by venetoclax 400 mg oral 6-8 hours later. Participants will continue this dose each week. The venetoclax dose will be reduced to 100 mg once per week if the participant is being treated with posaconazole or voriconazole (strong CYP3A4 inhibitors) (considered dose equivalent to venetoclax 400 mg 1X/week). The venetoclax dose will be reduced 200 mg once per week if the participant is being treated with fluconazole or isavuconazole (moderate CYP3A4 inhibitors) (considered dose equivalent to venetoclax 400 mg 1X/week). This clinical trial is administering venetoclax well below the current FDA approved dosing.

DRUG

Decitabine

Decitabine is a hypomethylating agent. It is administered at low doses and used in combination with venetoclax to manage participants with acute myeloid lymphoma who have undergone stem cell transplant. Participants initiate therapy with 5 mg/m2 decitabine subcutaneous every week followed by venetoclax.

Trial Locations (1)

44106

RECRUITING

University Hospitals Seidman Cancer, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
lead

Benjamin Tomlinson

OTHER

NCT06129734 - Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant | Biotech Hunter | Biotech Hunter