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

Description

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

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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Study Overview

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Study Details

Study overview

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).

Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL

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

Condition
Non-Hodgkin Lymphoma
Intervention / Treatment

-

Contacts and Locations

Valhalla

New York Medical College, Valhalla, New York, United States, 10595

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

3 Years to 31 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

New York Medical College,

Mitchell Cairo, MD, STUDY_CHAIR, New York Medical College

Matthew Barth, MD, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

2024-12