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All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients without CNS involvement will receive one dose of Liposomal cytarabine for CNS prophylaxis on day -13. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting one day prior to the Liposomal cytarabine. Dexamethasone 0.15 mg/kg/dose (max 4mg) IV BID will be given days -14 to -10. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.

All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients with positive CSF prior to enrollment will receive treatment with two doses of Liposomal cytarabine during the prephase portion of therapy. Liposomal cytarabine will be given intrathecally on days -13 and -5. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting the day prior to the Liposomal cytarabine. Dexamethasone will be given days -14 to -10 and days -6 through -2. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.

Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.

Will be given intrathecally for both prophylaxis and treatment of CNS disease.

Liposomal ARA-C

Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.

Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.

Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).

Mitchell Cairo, MD

Jessica Hochberg, MD

Matthew Barth, MD

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).

Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL

Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL

Patients will be monitored for adverse reactions and events of drug when given alone and in combination with ICE chemotherapy.

Patients will be assessed following each treatment cycle for regression of tumor.

Roswell Park Cancer Institute

New York Medical College

Vice Chair

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL	NCT02393157	Non-Hodgkin Lym... Burkitt Lymphom... Diffuse Large B... Primary Mediast... CD20+ Lymphobla... Follicular Lymp...	Obinutuzumab Liposomal ARA-C Ifosfamide Carboplatin Etoposide	3 Years - 31 Years	New York Medical College
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL	NCT02393157	Non-Hodgkin Lym... Burkitt Lymphom... Diffuse Large B... Primary Mediast... CD20+ Lymphobla... Follicular Lymp...	Obinutuzumab Liposomal ARA-C Ifosfamide Carboplatin Etoposide	3 Years - 31 Years	New York Medical College

Spots Global Cancer Trial Database for cd20+ lymphoblastic lymphoma