54767414ALL2005, An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects ≥1 and ≤30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Study ID: STU-2018-0001
This open-label, multicenter, Phase 2 study will enroll approximately 49 subjects aged 1 to [Less Than]18 years with relapsed/refractory aLL and a maximum of 69 total subjects 1 and 30 years of age with relapsed/refractory aLL/LL. Cohort 1 will evaluate the safety and efficacy of daratumumab in combination with vincristine and prednisone in subjects with B-cell aLL/LL in second relapse or greater. Cohort 2 will evaluate the safety and efficacy of daratumumab in combination with a standard 4-drug re-induction regimen (prednisone, vincristine, doxorubicin, and PeG-asparaginase) in subjects with T-cell aLL/LL in first relapse.
The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell aLL and T-cell aLL as measured by the CR rate. Secondary objectives: - To assess the efficacy of daratumumab, including oRR, relapse-free survival (RFS), eFS, and oS in pediatric and young adult subjects with B-cell and T-cell aLL/LL, and minimal residual disease (MRD) negative rate in subjects with B-cell and T-cell aLL - To assess the safety and tolerability of daratumumab in pediatric and young adult subjects with B-cell and T-cell aLL/LL - To assess the PK of daratumumab in pediatric and young adult subjects with B-cell and T-cell aLL/LL - To assess daratumumab immunogenicity in pediatric and young adult subjects with B-cell aLL and T-cell aLL/LL - To assess daratumumab concentration in cerebrospinal fluid (CSF) exploratory objectives: - To explore biomarkers predictive of response or resistance to therapy - To assess expression of CD38 at study entry and at relapse