NCT03826992 Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
| NCT ID | NCT03826992 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 21 participants |
| Start Date | 2018-12-27 |
| Primary Completion | 2027-01 |
Trial Parameters
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Brief Summary
This study evaluates the safety and tolerability of combining venetoclax with Vyxeos (CPX-351) in pediatric and young adult patients with acute leukemia that has come back or not responded to treatment.
Eligibility Criteria
Inclusion Criteria: * Ages 1 Year to 39 Years * Diagnosis of one of the following: * Acute myeloid leukemia (AML), any subtype except * Patients with acute promyelocytic leukemia (APML) are NOT eligible * Patients with ML-DS are NOT eligible * Myeloid sarcoma * Acute leukemia of ambiguous lineage (ALAL) * Acute undifferentiated leukemia (AUL) * T/myeloid mixed phenotype acute leukemia (MPAL) * B/myeloid MPAL * MPAL with KMT2A-rearrangement MPAL with t (9;22) are NOT eligible * T-cell acute lymphoblastic leukemia (T ALL) * Early thymocyte precursor (ETP) ALL * KMT2A-rearranged ALL * Disease Status * Relapsed/Refractory AML, MPA, and AUL * Untreated therapy related AML * Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETEP ALL * Karnofsky/Lanksy performance level score of greater than or equal to 50 percent. * Prior therapy requirements * Fully recovered from acute toxicities of Hematopoietic Stem Cell Transplant (HSCT) or Anthracycline Exposure * 14 days must have elapsed since th
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