Using obinutuzumab with chemotherapy for relapsed CD20+ Non-Hodgkin Lymphoma in young patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of obinutuzumab, both alone and in combination with ICE chemotherapy (ifosfamide, carboplatin, and etoposide), for children, adolescents, and young adults with relapsed CD20 positive B-cell Non-Hodgkin Lymphoma. Participants will be assessed for their response to treatment and any associated side effects. The study focuses on patients who have experienced a first relapse or primary induction failure of specific types of B-cell leukemia/lymphoma. The goal is to improve treatment outcomes for this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• New York Medical College
  Valhalla, New York, United States Recruiting

Study contacts

• Study coordinator: Mitchell Cairo, MD
• Email: Mitchell_Cairo@nymc.edu
• Phone: 914-594-2150

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combination treatment for relapsed B-cell lymphoma

  This study is testing a new combination of five drugs to see if it can help people with relapsed or hard-to-treat B-cell lymphoma feel better.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT03223610

• Non-Hodgkin Lymphoma Sample Collection for MRD Testing

  This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.

  Recruiting Natera, Inc. · Austin, Texas · NCT07750886

• Gene therapy for certain blood cancers

  This study is testing a new gene therapy called VNX-101 to see if it can help people with certain types of blood cancers that haven't responded to other treatments.

  Recruiting at 11 sites Phase 1/2 Vironexis Biotherapeutics Inc. · Duarte, California and 10 other locations · NCT06533579

• Study of crushed venetoclax tablets dissolved in liquid for pediatric patients

  This study tests if crushing venetoclax tablets and mixing them with liquid helps children with blood cancers absorb the medication better and stay safe while taking it.

  Recruiting at 5 sites Children's Hospital Medical Center, Cincinnati · Aurora, Colorado and 5 other locations · NCT06131801

• Using LV20.19 CAR T-Cells with Pirtobrutinib for B-cell Malignancies

  This study is testing a new treatment combining LV20.19 CAR T-cells with pirtobrutinib to see if it helps adults with tough-to-treat B-cell cancers feel better.

  Recruiting Phase 1 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT05990465

• Using modified T cells to treat relapsed or refractory Non-Hodgkin Lymphoma

  This study is testing a new treatment using modified T cells to see if it can help people with relapsed or hard-to-treat Non-Hodgkin Lymphoma.

  Recruiting Phase 1 University of California, San Francisco · San Francisco, California · NCT04545762

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.