Trials / Recruiting
RecruitingNCT02393157
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- New York Medical College · Academic / Other
- Sex
- All
- Age
- 3 Years – 31 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Non-Hodgkin Lymphoma
- Burkitt Lymphoma
- Diffuse Large B-Cell Lymphoma
- Primary Mediastinal B-cell Lymphoma
- CD20+ Lymphoblastic Lymphoma
- Follicular Lymphoma, Grade III
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Obinutuzumab | Drug will be given alone in a pre-phase and in combination with ICE chemotherapy. |
| DRUG | Liposomal ARA-C | Will be given intrathecally for both prophylaxis and treatment of CNS disease. |
| DRUG | 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. |
| DRUG | Carboplatin | Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2. |
| DRUG | Etoposide | Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2). |
Timeline
- Start date
- 2015-08-21
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2015-03-19
- Last updated
- 2025-08-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02393157. Inclusion in this directory is not an endorsement.