Azacitidine and Venetoclax as Induction Therapy With Venetoclax Maintenance in the Elderly With AML

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03466294
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine and Venetoclax — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 15, 2018
Status verified
Apr 2026
Primary completion
Jan 29, 2025
Completion
Dec 4, 2025

Study Design

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

Arms

  • Experimental: Azacitidine and Venetoclax
    On day 1 of cycle 1, Azacitidine 75 mg/m2 will be given by injection or infusion, and will continue for 7 days. Azacitidine doses will be given in subsequent cycles for patients who do not achieve response. Venetoclax will be administered orally once daily on days 2 through 28 in cycle 1. Beginning with cycle 2, and each subsequent cycle, venetoclax will be administered Days 1 through 28.

Primary Outcome Measure

Duration of Remission Response to Azacitidine and Venetoclax Treatment + Maintenance Therapy [ Time Frame: From the first day a response is documented to the first day of disease progression ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045-

Find similar trials in Aurora, CO

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

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