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
ClinicalTrials ID:NCT05533775
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
| Parameter | Options |
|---|
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| UCSF Benioff Children's Hospital Oakland | 94609 | Oakland | California |
| Kaiser Permanente Oakland Medical Center | 94611 | Oakland | California |
| Kaiser Permanente - Roseville | 95661 | Roseville | California |
| Kaiser Permanente - Santa Clara | 95051 | Santa Clara | California |
| Johns Hopkins University | 21231 | Baltimore | Maryland |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Childrens Mercy Hosp & Clinics | 64108 | Kansas City | Missouri |
| MSKCC | 10065 | New York | New York |
| Cincinnati Children's Hospital Medical Center | 45229 | Cincinnati | Ohio |
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