At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Daratumumab, Vincristine, and 7 other interventions for Precursor Cell Lymphoblastic Leukemia-Lymphoma. Completed, enrolled 47 participants across 53 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.
Study Details
Timeline
Interventions
Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2.
Participant will receive vincristine 1.5 milligram per meter square (mg/m\^2) in cohort 1 and cohort 2.
Participant will receive prednisone 40 mg/m\^2 in cohort 1 and cohort 2.
Participant will receive doxorubicin 60 mg/m\^2 in cohort 2.
Participant will receive peg-asparaginase 2500 units per meter square (U/m\^2) in cohort 2.
Participant will receive cyclophosphamide 1 gram per meter square (g/m\^2) once in cohort 2.
Participant will receive cytarabine 75 mg/m\^2 in cohort 2.
Participant will receive 6-mercaptopurine 60 mg/m\^2 orally daily in cohort 2.
Participant will receive methotrexate 5 g/m\^2 intravenously (IV) in cohort 2.