Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03735875
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Acute Myeloid Leukemia With FLT3/ITD Mutation
  • Recurrent Acute Myeloid Leukemia
  • Refractory Acute Leukemia

Eligibility Criteria

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

Interventions

  • Quizartinib — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO

Study Details

This phase Ib/II trial studies the side effects and best dose of venetoclax in combination with quizartinib and how well they work in treating patients with acute myeloid leukemia that has come back or does not respond to treatment, and who are FLT3-mutation positive. Venetoclax and quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jan 25, 2019
Status verified
Aug 2024
Primary completion
Jul 26, 2023
Completion
Jul 26, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Treatment (venetoclax, quizartinib)
    Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
  • Experimental: Phase II: Treatment (venetoclax, quizartinib)
    Patients will be treated at the established dose from the phase I portion of the study. Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) as Determined by Dose Limiting Toxicity (Phase Ib) [ Time Frame: Up to 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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