NCT06466395 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
| NCT ID | NCT06466395 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Refractory Acute Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief Summary
To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.
Eligibility Criteria
Inclusion Criteria: 1. Relapsed/refractory leukemias as defined as: 1. Pediatric, adolescent, or young adult patients with relapsed or refractory acute leukemias that are of the lymphoid lineage including bi-phenotypic or undifferentiated leukemias as per NCCN v2.2021 and W.H.O. classification in relapse or primary refractory. 2. Participants must have ≥5% blasts in the bone marrow as assessed by morphology. However, if an adequate bone marrow sample cannot be obtained, patients may be enrolled if there is unequivocal evidence of leukemia with ≥5% blasts in the peripheral blood. 2. Participants have adequate performance status (ECOG ≤2) for patients ≥16 years old, Lansky score \>50 for patients \<16 years old. 3. Participants must be ≥ 2 years old or less than or equal to 21 years of age at time of signing/or having proxy sign the informed consent to be enrolled on study. 4. Participants with asymptomatic CNS disease are eligible. 5. These conditions are allowed on study: conditions re
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