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

Trial Status: Active

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).

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

Ohio

Columbus
Nationwide Children's Hospital
Status: IN_REVIEW

Trial Phase Phase II

Trial Type Treatment

Lead Organization
New York Medical College

  • Primary ID L-11,392
  • Secondary IDs NCI-2019-05721
  • Clinicaltrials.gov ID NCT02393157