Study on Obinutuzumab and ICE Chemotherapy for Difficult or Returning CD20+ Non-Hodgkin Lymphoma

Sponsor: New York Medical College

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02393157

Provider View

This clinical trial is testing the safety and effectiveness of a treatment combining obinutuzumab with ICE chemotherapy for children, adolescents, and young adults with CD20 positive B-cell Non-Hodgkin Lymphoma that has returned or not responded to initial treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if using obinutuzumab alone or together with a chemotherapy combination called ICE (ifosfamide, carboplatin, and etoposide) is safe and effective in treating children, adolescents, and young adults with CD20 positive B-cell Non-Hodgkin Lymphoma (B-NHL) that has come back or not responded to initial treatments.

Eligibility Criteria

Inclusion Criteria

  • Patients with CD20 positive B-cell leukemia/lymphoma that has returned or not responded to initial treatment, 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
  • Patients over 16 years old must have a Karnofsky score of 60% or higher, and those 16 or younger must have a Lansky score of 60 or higher.
  • Must not have received myelosuppressive chemotherapy within 2 weeks before joining the study.
  • Must not have had previous treatment with obinutuzumab (GA101).
  • Must have completed any local radiation therapy more than 2 weeks ago, and more than 6 months ago for certain extensive radiation treatments.
  • May have had prior steroid treatment, but not started more than 7 days before beginning the study treatment.
  • Must have adequate organ function.

Exclusion Criteria

  • Patients with newly diagnosed, untreated B-NHL.
  • Patients with known immune deficiencies.
  • Patients who have had a solid organ transplant.
  • Patients who have had an allogeneic stem cell transplant within the last 60 days or have severe active Graft-vs-Host Disease.
  • Patients with a history of severe allergic reactions to certain antibodies.
  • Patients with uncontrolled hepatitis B or C infections.

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