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Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Sponsor: 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).
Official title: Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL
Key Details
Gender
All
Age Range
3 Years - 31 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2015-08-21
Completion Date
2027-12
Last Updated
2025-08-08
Healthy Volunteers
No
Conditions
Interventions
Obinutuzumab
Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
Liposomal ARA-C
Will be given intrathecally for both prophylaxis and treatment of CNS disease.
Ifosfamide
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
Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
Etoposide
Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
Locations (1)
New York Medical College
Valhalla, New York, United States