CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 50 target
Drug / intervention
Azacitidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04062266
NCT04062266Phase 2ActiveOn Track
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Phase II Study of 5-Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remission

M.D. Anderson Cancer Center·interventional·Posted Aug 20, 2019·Updated Jun 8, 2026

In Brief

A Phase 2 clinical trial evaluating Azacitidine and Venetoclax for Acute Myeloid Leukemia in Remission and 5 related conditions. Active but no longer recruiting, targeting 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia in Remission, FLT3 Gene Mutation, Hematologic and Lymphocytic Disorder, Acute Myeloid Leukemia, Minimal Residual Disease Persistence, Therapy-Related Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Genentech, Inc.

Timeline

Phase 2Active
202020212022202320242025202620272028202920302031
First PostedAug 20, 2019
Enrollment StartSep 13, 2019
Primary CompletionOct 31, 2030
TodayJul 1, 2026
Enrollment to primary: 11.1 yearsPosted 6.9 years agoPrimary completion in 4.3 years

Arms & Interventions

Treatment (azacytidine, venetoclax)experimental

Patients receive azacitidine SC or IV over 1 hour daily on days 1-5, and venetoclax PO daily on days 1-14. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Drug: AzacitidineDrug: Venetoclax

Interventions

Azacitidinedrug

Given SC or IV

Venetoclaxdrug

Given PO