Actively Recruiting
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Led by New York Medical College · Updated on 2025-08-08
25
Participants Needed
1
Research Sites
640 weeks
Total Duration
On this page
Sponsors
N
New York Medical College
Lead Sponsor
R
Roswell Park Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients in first relapse or primary induction failure with CD20 positive B-cell leukemia/lymphoma including Diffuse Large B-Cell Lymphoma, Burkitt Lymphoma, High Grade B-cell Lymphoma Not Otherwise Specified, Primary Mediastinal B-cell Lymphoma, CD20+ B-lymphoblastic lymphoma, and Follicular lymphoma Grade III
- Karnofsky score 60% for patients older than 16 years
- Lansky score 60 for patients 16 years or younger
- No myelosuppressive chemotherapy received within 2 weeks prior to study entry
- No prior therapy with obinutuzumab (GA101)
- Radiation therapy dates: more than 2 weeks since local palliative XRT, more than 6 months since craniospinal or >50% pelvic radiation, more than 6 weeks since other substantial bone marrow radiation
- Prior steroid treatment allowed if started no more than 7 days before protocol therapy
- Adequate organ function
You will not qualify if you...
- 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 grade 3 or higher
- History of grade 4 anaphylactic reactions to humanized or murine monoclonal antibodies
- Uncontrolled hepatitis B and/or C infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
Research Team
M
Mitchell Cairo, MD
CONTACT
J
Jessica Hochberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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