Study on Glofitamab Alone and with Chemoimmunotherapy for Children and Young Adults with Relapsed or Hard-to-Treat B-Cell Non-Hodgkin Lymphoma

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05533775

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, glofitamab, both by itself and combined with other cancer treatments, in children and young adults with B-cell Non-Hodgkin Lymphoma that has returned or is difficult to treat.

Patient Parameters

Program Overview

The aim of this study is to see if the drug glofitamab, used alone or with a combination of other cancer drugs (rituximab, ifosfamide, carboplatin, and etoposide), is safe and effective for children and young adults with B-cell Non-Hodgkin Lymphoma that has come back or is not responding to treatment.

Eligibility Criteria

Inclusion Criteria

  • Age between 6 months and under 18 years for Part 1 and Cohort B, and between 6 months and 30 years for Part 2.
  • Confirmed diagnosis of aggressive B-cell Non-Hodgkin Lymphoma that shows the CD20 marker, including specific types like Burkitt Lymphoma and Diffuse Large B-Cell Lymphoma.
  • Cancer that has not responded to initial treatment or has returned after treatment.
  • At least one tumor that can be measured by scans or a certain percentage of cancer cells in the bone marrow.
  • Good overall health as measured by specific performance scales.
  • Healthy bone marrow, liver, and kidney function.
  • Negative tests for hepatitis B, hepatitis C, and HIV, unless HIV is well-controlled.
  • Negative COVID-19 test within 7 days before joining the study.
  • Willingness of participants and caregivers to complete study assessments.

Exclusion Criteria

  • Cancer only in the central nervous system (CNS) without affecting other parts of the body.
  • Previous treatment with glofitamab.
  • Ongoing severe side effects from past cancer treatments.
  • Active infections not resolved before starting the study.
  • Previous organ transplant.
  • History of certain immune system disorders or chronic viral infections.
  • Active autoimmune diseases needing treatment.
  • Severe allergic reactions to similar treatments in the past.
  • History of certain brain diseases or conditions.
  • Major surgery or injury within 28 days before starting the study treatment.
  • Recent live vaccine within 4 weeks before starting the study treatment or during the study.

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