AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04062266
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia in Remission
  • FLT3 Gene Mutation
  • Hematologic and Lymphocytic Disorder
  • Minimal Residual Disease Persistence
  • Therapy-Related Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Given SC or IV
  • Venetoclax — DRUG
    Given PO

Study Details

This phase II trial studies how well azacitidine and venetoclax work in treating patients with acute myeloid leukemia that is in remission. Drugs used in chemotherapy, such as azacitidine 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
Sep 13, 2019
Status verified
Jun 2026
Primary completion
Oct 31, 2030
Completion
Oct 31, 2030

Study Design

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

Arms

  • Experimental: Treatment (azacytidine, venetoclax)
    Patients receive azacitidine SC or IV over 1 hour daily on days 1-5, and venetoclax PO daily on days 1-14. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Relapse-free survival (RFS) [ Time Frame: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), assessed for up to 10 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
M D Anderson Cancer Center· Houston, TX

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