A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06466395
Phase
PHASE1
Status
Recruiting
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Conditions

  • Bi-Phenotypic Leukemia
  • Refractory Acute Leukemia
  • Relapsed Acute Leukemia
  • Undifferentiated Leukemia

Eligibility Criteria

Sex
ALL
Age
2 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Given by PO
  • Hyper-CVAD — DRUG
    Given by IV

Study Details

To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.

Key Dates

Start date
Feb 18, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2031

Study Design

Enrollment
22 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a
    Participants enrolled in Phase 1a, the dose of venetoclax the participant receive will depend on when the participant joins this study. The first group of participants will receive the lowest dose level of venetoclax. Each new group will receive a higher dose of venetoclax than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of venetoclax is found. The study doctor will discuss with you the doses the participants will receive as part of hyper-CVAD based on standard of care.
  • Experimental: Phase 1b
    Participants enrolled in Phase 1b, will receive venetoclax at the recommended dose that was found in Phase 1. The study doctor will discuss with you the doses the participants will receive as part of hyper-CVAD based on standard of care.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
David McCall, MD
[email protected]
713-792-6604
David McCall, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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