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

Recruiting now · Phase 2

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

In brief

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).

Key facts

Study ID

NCT02393157

Run by

New York Medical College

People needed

25

Starts

2015-08-21

Expected to finish

2027-12-01

Last updated by the study team

2025-08-08

Who can join

Age: 3 and older, up to 31. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• New York Medical College — Valhalla, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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