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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03573024
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 28, 2018
Status verified
May 2026
Primary completion
Apr 14, 2025
Completion
Feb 19, 2026

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Azacitidine and Venetoclax
    Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished.

Primary Outcome Measure

Response Rate, Measured by the European Leukemia Net Definition: (CRMRD-+CR+CRi+MLFS) [ Time Frame: Study start date to study end date, or death, whichever comes first, approximately 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Universtiy of Colorado HospitalAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Universtiy of Colorado Hospital· Aurora, CO

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