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Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia

NCT03573024 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-05-07

No results posted yet for this study

Summary

This study aims to treat non-elderly adult patients, who were previously untreated for acute myeloid leukemia, using venetoclax and azacitidine.

Conditions

Interventions

DRUG

Azacitidine

On day 1 of cycle 1, azacitidine 75 mg/m2 SC or IV will be given, and will continue for 7 days.

DRUG

Venetoclax

Starting on day 1 of cycle 1, venetoclax will be initiated. It will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4. The patient then continues to take the 600mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day. On days the subject is given azacitidine, venetoclax must be given first.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Daniel Pollyea, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2025-04-14
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573024 on ClinicalTrials.gov