Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL
Summary
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).
Arms & interventions
- DrugObinutuzumab
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
- DrugLiposomal ARA-C
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
- DrugIfosfamide
Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.
- DrugCarboplatin
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
- DrugEtoposide
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Outcome measures
Primary
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.
Time frame: 1 month
Response rate assessed following each treatment cycle for regression of tumor
Patients will be assessed following each treatment cycle for regression of tumor.
Time frame: 3 months
Eligibility criteria
Study locations (1)
New York Medical College
Valhalla, New York, 10595