Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL
New York Medical College
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).
Eligibility
- Age range
- 3–31 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients in first relapse or primary induction failure CD20 positive B-cell leukemia/lymphoma including: * Diffuse Large B-Cell Lymphoma * Burkitt Lymphoma * High Grade B-cell Lymphoma: Not Otherwise Specified (NOS) * Primary mediastinal B-cell lymphoma (PMBL) * CD20+ B-lymphoblastic lymphoma * Follicular lymphoma, Grade III * Karnofsky ≥ 60% for patients \> 16 years of age and * Lansky ≥ 60 for patients ≤ 16 years of age. * Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study. * Patients may not have received…
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).
Location
- New York Medical CollegeValhalla, New York