CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Azacitidine and Venetoclaxdrug
Likely dose
Azacitidine and Venetoclax 75mg/m2from 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/NCT03466294
NCT03466294Phase 2Completed
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Azacitidine and Venetoclax (ABT-199) as Induction Therapy With Venetoclax Maintenance in Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)

University of Colorado, Denver·interventional·Posted Mar 15, 2018·Updated Apr 9, 2026

In Brief

A Phase 2 clinical trial evaluating Azacitidine and Venetoclax for Acute Myeloid Leukemia. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This study is being done to determine if treatment with azacitidine and venetoclax is effective treatment for elderly patients with acute myeloid leukemia (AML) who have not received previous treatment. Azacitidine and venetoclax will be given as induction treatment followed by venetoclax maintenance treatment for patients who respond to the induction treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 15, 2018
Enrollment StartMay 15, 2018
Primary CompletionJan 29, 2025
Study CompletionDec 4, 2025
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 8.3 years ago

Interventions

Azacitidine and Venetoclaxdrug

Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.