Study on Optimizing Cytokine Release Syndrome for Glofitamab with Gemcitabine and Oxaliplatin in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT06806033
This clinical trial is exploring how often and how severe cytokine release syndrome (CRS) occurs in patients with diffuse large B-cell lymphoma (DLBCL) who are treated with a combination of glofitamab, gemcitabine, and oxaliplatin, followed by glofitamab alone.
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Program Overview
The main aim of this study is to understand the frequency and severity of cytokine release syndrome (CRS) in patients with diffuse large B-cell lymphoma (DLBCL) who are treated with a combination of the drugs glofitamab, gemcitabine, and oxaliplatin. After this combination treatment, patients will continue with glofitamab alone. CRS is a common side effect of certain cancer treatments, and this study seeks to optimize its management in this specific drug combination.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with diffuse large B-cell lymphoma (DLBCL).
- The cancer has either returned after treatment or did not respond to previous treatment.
- Have had at least one previous treatment for the cancer.
- Not eligible for high-dose chemotherapy followed by stem cell transplant if only one prior treatment has failed.
- Have at least one tumor that can be measured by a scan.
- Be in relatively good health with an ECOG performance status of 0, 1, or 2.
- Have adequate blood and kidney function.
Exclusion Criteria
- Previously participated in certain related studies.
- Eligible for stem cell transplant if only one prior treatment has failed.
- History of certain types of lymphoma or specific genetic changes in the cancer.
- Allergic reactions to certain antibodies or drugs used in the study.
- Previous treatment with glofitamab or similar drugs.
- Previous treatment with gemcitabine or oxaliplatin.
- Significant nerve damage or numbness.
- Recent cancer treatments or participation in other clinical trials.
- Cancer that has spread to the brain or spinal cord.
- History of certain brain or nervous system diseases.
- Other active cancers, with some exceptions.
- Significant heart or lung disease.
- Active infections or recent major infections.
- Positive for certain viruses or infections.
- History of certain immune system disorders.
- Unresolved side effects from previous cancer treatments.
- Recent vaccination with live vaccines.
- Previous organ or stem cell transplants.
- Active autoimmune diseases requiring treatment.
- Recent use of certain immune-suppressing medications.
- Recent major surgery.
- Significant liver disease.
- Any other condition that may interfere with the study or increase risk.
- Pregnant or breastfeeding, or planning to become pregnant during or shortly after the study.
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