Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Set… (NCT04128501) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Venetoclax and Azacitidine for the Treatment of Acute Myeloid Leukemia in the Post-Transplant Setting
United States100 participantsStarted 2020-05-05
Plain-language summary
This phase II trial studies how well venetoclax and azacitidine work for the treatment of acute myeloid leukemia after stem cell transplantation. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax and azacitidine after a stem cell transplant may help control high risk leukemia and prevent it from coming back after the transplant.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Participants 18 to 75 years of age.
✓. English and non-English speaking patients are eligible.
✓. Disease diagnosis with one of the hematological malignancies listed below and who are in morphological remission after allogeneic stem cell transplantation with PBSCs or bone marrow.
✓. AML if they had at least one of the following disease characteristics:
✓. Biphenotypic or bilineage leukemia (including a myeloid component) OR mixed phenotype acute leukemia (MPAL) OR
✓. Participants with acute lymphoblastic leukemia; B cell or T cell in original.
✓. Participants in morphological remission with no detectable minimal residual disase (MRD) after transplant
✓. Participants who are in remission with no detectable minimal residual disease (MRD) after allogeneic stem cell transplant should have:
Exclusion criteria
✕. Active acute GVHD grade II or higher.
What they're measuring
1
Relapse-free survival (RFS) time
Timeframe: From the date of first administration of venetoclax + azacitidine (vidaza) (V+V), assessed up to 60 days after last V+V dose