Children's Hospital Medical Center, Cincinnati
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.
This is a single-institution Phase I pilot study designed to test the safety and tolerability of combining venetoclax with Vyxeos (CPX-351, cytarabine and daunorubicin liposome) for the treatment of relapsed/refractory acute leukemia in young patients. Subjects will receive a single course of study therapy consisting of daily, oral or crushed venetoclax at an assigned dose level with a 3-day ramp-up to target dose and Vyxeos administered intravenously at the established dose on Days 1, 3, and 5. In addition to safety and tolerability, the overall response rate to these therapies will be estima…
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) AL…
Vyxeos Dose: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 administered via intravenous infusion over 90 minutes on Days 1, 3, and 5.
Venetoclax Dose: 1. Dose Level 0 - weight based daily dosing for 21 days 2. Dose Level -1 - weight based daily dosing for 14 days 3. Dose Level -2- weight based daily dosing for 10 days 4. Dose Level -3- weight based daily dosing for 7 days
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