A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05268003
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ponatinib — DRUG
    Given by PO
  • Venetoclax — DRUG
    Given by PO
  • Mini-hyper CVD — DRUG
    Given by IV (vein)

Study Details

The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia

Key Dates

Start date
Jun 7, 2022
Status verified
Apr 2026
Primary completion
Apr 21, 2026
Completion
Apr 21, 2026

Study Design

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

Arms

  • Experimental: Ponatinib
    Participants will receive ponatinib (45mg daily) as a single agent for 3 days. These will be called Days -3, -2 and -1
  • Experimental: Venetoclax
    Patients will continue venetoclax 400mg daily on days 1-14 of each 28-day cycle.
  • Experimental: Mini-hyper-CVD
    Chemotherapy will be administered in the inpatient setting, starting on day 1 of each of the cycles 2-8.

Primary Outcome Measure

To determine the complete remission (CR) / CR with incomplete count recovery (CRi) rate with the combination of Ponatinib and mini-hyper-CVD chemotherapy and venetoclax. [ Time Frame: through study completion, an average of 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

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

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