RecruitingRecruiting
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
NCT02393157 · New York Medical College
In plain English
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Official title
Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL
About this study
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 criteria
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 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 Criteria:
* Patients with newly diagnosed, previously untreated B-NHL.
* Known congenital or acquired immune deficiency.
* 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
Study design
Enrollment target: 25 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2015-08-21
Estimated completion: 2027-12
Last updated: 2025-08-08
Interventions
Drug: ObinutuzumabDrug: Liposomal ARA-CDrug: IfosfamideDrug: CarboplatinDrug: Etoposide
Primary outcomes
- • Safety as assessed by adverse reactions and events (1 month)
- • Response rate assessed following each treatment cycle for regression of tumor (3 months)
Sponsor
New York Medical College · other
With: Roswell Park Cancer Institute
Contacts & investigators
ContactMitchell Cairo, MD · contact · Mitchell_Cairo@nymc.edu · 914-594-2150
ContactJessica Hochberg, MD · contact · jessica_hochberg@nymc.edu · 914-594-2150
InvestigatorMitchell Cairo, MD · study_chair, New York Medical College
All locations (1)
New York Medical CollegeRecruiting
Valhalla, New York, United States