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Obinutuzumab and ICE Chemotherapy for Relapsed CD20+ Non-Hodgkin Lymphoma

This study is looking at a treatment for children, adolescents, and young adults (ages 3-31) with certain types of relapsed (returned) CD20 positive B-cell Non-Hodgkin Lymphoma. It tests the safety and effectiveness of a drug called Obinutuzumab, first by itself and then combined with a chemotherapy regimen called ICE (Ifosfamide, Carboplatin, and Etoposide). Another drug, Liposomal ARA-C, will be given into the spinal fluid to prevent or treat cancer in the brain and spinal cord. The study aims to see how many patients respond to this treatment and to track any side effects. This study is currently recruiting up to 25 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 25 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be assessed for one month, and tumor response will be measured for three months after each treatment cycle.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02393157

Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL

Recruiting
PHASE2Ages 3–31InterventionalTreatment
New York Medical College
~25 participants
Updated 2025-08-08 on ClinicalTrials.gov
What's tested:ObinutuzumabLiposomal ARA-CIfosfamideCarboplatinEtoposide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as assessed by adverse reactions and events
Measured over 1 month
+1 more outcome measured

Conditions

Non-Hodgkin Lymphoma
Burkitt Lymphoma
Diffuse Large B-Cell Lymphoma
Primary Mediastinal B-cell Lymphoma
CD20+ Lymphoblastic Lymphoma
Follicular Lymphoma, Grade III

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NCT02393157

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • New York Medical College

    Valhalla, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mitchell Cairo, MD · STUDY_CHAIR · New York Medical College

Who to contact

Mitchell Cairo, MD
[email protected]
914-594-2150
Email the study team

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Eligibility criteria

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.
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

What this trial measures

  • Safety as assessed by adverse reactions and events1 month

    Patients will be monitored for adverse reactions and events of drug when given alone and in combination with ICE chemotherapy.

  • Response rate assessed following each treatment cycle for regression of tumor3 months

    Patients will be assessed following each treatment cycle for regression of tumor.