AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission (NCT04062266) | Clinical Trial Compass
Active ā Not RecruitingPhase 2
AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission
United States50 participantsStarted 2019-09-13
Plain-language summary
This phase II trial studies how well azacitidine and venetoclax work in treating patients with acute myeloid leukemia that is in remission. Drugs used in chemotherapy, such as azacitidine and venetoclax, 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Patients aged \>/= 18 years AML who have achieved their FIRST CR or CRi and are not immediately candidates for allogeneic stem cell transplant.
ā. Patients who have received intensive therapy (defined as receiving standard or higher dose cytarabine-based therapy) to achieve remission (CR/CRi) should have received remission induction therapy and at least 1 consolidation cycle. These patients are eligible as long as they are not greater than 2 months from their last consolidation therapy and will be enrolled in COHORT 1.
ā. Patients who have received lower intensity therapy (defined as receiving low-dose cytarabine (LDAC) or hypomethylating agent (HMA)-based therapy) to achieve remission should have received at least 2 cycles of lower intensity therapy between the time they have achieved CR/CRi and enrollment on this protocol. They will be treated on COHORT 2.
ā. For either subgroup (lower or higher intensity), patients who have measurable residual disease may be enrolled on their respective cohort at any time without maximum 'time from consolidation' requirement.
ā. ECOG performance status of \< or = 3
ā. Adequate organ function as follows:
ā. Serum total bilirubin \< or = to 1.5 X the Upper Limit of Normal (ULN)
ā. Serum creatinine \< or = to 2.5 x ULN
Exclusion criteria
ā. Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by FAB classification based on morphology, immunophenotype, molecular, or cytogenetic s studies.
What they're measuring
1
Relapse-free survival (RFS)
Timeframe: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), assessed for up to 10 years
. Diagnosis of AML associated t(15;17) or APL variant. Patients with t(9;22) are also ineligible unless they are unable or unwilling to receive therapy with a tyrosine kinase inhibitor.
ā. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
ā. Patients with active CNS (central nervous system) disease.
ā. Patients with documented hypersensitivity to any components of the study program.
ā. Females who are pregnant or lactating or intending to become pregnant during the study.
ā. Patients with history of extramedullary AML, except for CNS involvement that is currently controlled, will not be eligible for enrollment.
ā. Patient should be removed from current trial if they wish to participate and get treatment on another trial.