Testing Obinutuzumab with Chemotherapy for Returning B-Cell Lymphoma in Young People
Tests obinutuzumab, alone and with chemotherapy, in young people with returning B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Key facts
- Where
- Valhalla, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 31 years old?
Source: NCT02393157, who can take part
Where in United States
- New York Medical CollegeValhalla, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- New York Medical College
- Trial code
- NCT02393157
- Record updated
- 23 October 2026
- Original description
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).Read full original descriptionShow less
Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL
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).
Inclusion: 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 prior therapy with obinutuzumab (GA101); Radiation Therapy (XRT): Date of receiving prior XRT must be > 2 weeks for local palliative XRT (small port); > 6 months must have elapsed if prior craniospinal XRT or if > 50% radiation of pelvis; > 6 weeks must have elapsed if other substantial bone marrow radiation; Steroids: Patients may have received prior steroid treatment, but not started greater than 7 days prior to initiation of protocol therapy; Adequate organ function.
Exclusion: Patients with newly diagnosed, previously untreated B-NHL; Prior solid organ transplantation; Prior allogeneic stem cell transplant within 60 days or active acute Graft-vs-Host-Disease (GVHD) grade 3 or higher; History of grade 4 anaphylactic reactions to humanized or murine monoclonal antibodies; Uncontrolled hepatitis B and/or C infection; Known congenital or acquired immune deficiency.