NCT02393157RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 8 Mar 2015
- Start date
- 21 Aug 2015
- Primary completion date
- Dec 2026
- Lead sponsor
- New York Medical College
- NCT number
- NCT02393157
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 21 Aug 2015 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of grade 4 anaphylactic reactions to humanized or murine monoclonal antibodies
- Uncontrolled hepatitis B and/or C infection
Other
- Known congenital or acquired immune deficiency.
Who the study is looking for
- 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.
Age in the registry: 3 years to 31 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.