Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure

Part of paid clinical trials in Clovis, California.

Sponsor
Brian Jonas
Study ID
NCT04905810
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given IV
  • Decitabine — DRUG
    Given IV
  • Venetoclax — DRUG
    Given PO

Study Details

This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Key Dates

Start date
Feb 9, 2022
Status verified
May 2024
Primary completion
May 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (azacitidine, decitabine, venetoclax)
    Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7 (for patients with prior decitabine use), or decitabine IV on days 1-5 (for patients with prior azacitidine), and venetoclax PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 1 year ]

Locations (4)

FacilityCityStateZIPSite coordinators
UCSF-FresnoClovisCalifornia93611
Mohammed Bukari, MD
[email protected]
559-387-1900
Mohammed Bukari, MD (PRINCIPAL_INVESTIGATOR)
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Caspian Oliai
[email protected]
310-206-6909
Caspian Oliai (PRINCIPAL_INVESTIGATOR)
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Brian A. Jonas
[email protected]
916-734-3771
Brian A. Jonas (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Matthew J. Wieduwilt
[email protected]
405-217-8001
Matthew J. Wieduwilt (PRINCIPAL_INVESTIGATOR)

Find similar trials in Clovis, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UCSF-Fresno· Clovis, CAUCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of Oklahoma Health Sciences Center· Oklahoma City, OK

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