A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Re
To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia.
| Condition(s) | Refractory Acute Leukemia, Relapsed Acute Leukemia, Undifferentiated Leukemia, Bi-Phenotypic Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | To find the recommended dose of hyper-CVAD in combination with venetoclax that can be given to participants with relapsed or refractory leukemia. |
| Who can participate | 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 a |
| Ages | 2 Years to 21 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2025-02-18 |
| NCT ID | NCT06466395 |
| Official listing | https://clinicaltrials.gov/study/NCT06466395 |