Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03576547
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Philadelphia Chromosome Positive
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • t(9;22)

Eligibility Criteria

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

Interventions

  • Dexamethasone — DRUG
    Given PO or IV
  • Ponatinib Hydrochloride — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Venetoclax — DRUG
    Given PO

Study Details

This phase I/II trial studies the best dose of venetoclax when given together with ponatinib and dexamethasone and to see how well they work in treating participants with Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukemia or chronic myelogenous leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as venetoclax and dexamethasone, 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. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax, ponatinib, and dexamethasone may work better in treating participants with acute lymphoblastic leukemia or chronic myelogenous leukemia.

Key Dates

Start date
Jun 26, 2018
Status verified
May 2025
Primary completion
Jun 19, 2024
Completion
Jun 19, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I (400 mg Ponatinib) Treatment (ponatinib, venetoclax, dexamethasone, rituximab)
    The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
  • Experimental: Phase I (800 mg Ponatinib) Treatment (ponatinib, venetoclax, dexamethasone, rituximab)
    The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
  • Experimental: Phase II Ponatinib MDT
    Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Venetoclax When Given in Combination With Ponatinib and Dexamethasone (Phase I) [ Time Frame: Up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

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

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