The purpose of this study is to determine the safety of administering obinutuzumab as a single agent alone and in combination with ifosfamide, carboplatin, and etoposide (ICE) chemotherapy and determine the response rate of this treatment for children, adolescents and young adults (CAYA) with relapsed CD20 positive B-cell Non-Hodgkin Lymphoma (B-NHL).
Diffuse Large B-Cell Lymphoma
Burkitt Lymphoma
High Grade B-cell Lymphoma: Not Otherwise Specified (NOS)
Primary mediastinal B-cell lymphoma (PMBL)
Patients with newly diagnosed, previously untreated B-NHL.
Known congenital or acquired immune deficiency.
Prior solid organ transplantation.
Prior allogeneic stem cell transplant within 60 days or active acute Graft-vs-Host-Disease (GVHD) grade 3 or higher.
Parallel
Obinutuzumab
DrugDrug will be given alone in a pre-phase and in combination with ICE chemotherapy.
Liposomal ARA-C
DrugWill be given intrathecally for both prophylaxis and treatment of CNS disease.
Ifosfamide
DrugIfosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.
Carboplatin
DrugCarboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
Etoposide
DrugEtoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Safety as assessed by adverse reactions and events
Patients will be monitored for adverse reactions and events of drug when given alone and in combination with ICE chemotherapy.
Response rate assessed following each treatment cycle for regression of tumor
Patients will be assessed following each treatment cycle for regression of tumor.
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New York Medical College
Lead sponsor
Roswell Park Cancer Institute
Collaborator
