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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 28, 2018

Primary Completion Date

April 14, 2025

Study Completion Date

June 30, 2027

Conditions
Acute Myeloid Leukemia
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.

Trial Locations (1)

80045

Universtiy of Colorado Hospital, Aurora

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

University of Colorado, Denver

OTHER