Glofitamab + Chemotherapy for Non-Hodgkin's Lymphoma
Trial Summary
What is the purpose of this trial?
This trial is testing a new drug called glofitamab combined with other cancer drugs in patients with a type of lymphoma that hasn't responded to previous treatments. The treatment works by helping the immune system attack cancer cells and using chemotherapy to kill or stop the growth of these cells.
Do I need to stop my current medications to join the trial?
The trial requires that you stop certain cancer treatments, like chemotherapy and immunotherapy, at least 2 weeks before starting the study. If you're on monoclonal antibodies for cancer, you need to stop them 4 weeks before. If you're taking corticosteroids, you must be on a stable dose of 30 mg/day or less for at least 4 weeks before starting the trial.
What data supports the effectiveness of the drug combination Glofitamab + Chemotherapy for Non-Hodgkin's Lymphoma?
The combination of rituximab with chemotherapy has shown improved outcomes in various types of lymphomas, such as increased progression-free survival in mantle cell lymphoma and improved response rates in diffuse large B-cell lymphoma. Additionally, the ICE regimen (ifosfamide, carboplatin, and etoposide) has been effective for patients with relapsed or refractory non-Hodgkin's lymphoma.12345
What safety data exists for the combination of Glofitamab and chemotherapy drugs like Carboplatin, Ifosfamide, and Etoposide?
The combination of Carboplatin, Ifosfamide, and Etoposide has been studied in various trials, showing that the main safety concerns are myelosuppression (a decrease in bone marrow activity leading to fewer blood cells), including neutropenia (low white blood cell count) and thrombocytopenia (low platelet count). Other side effects include nausea, fatigue, and mild nerve damage, but these are generally manageable.678910
What makes the Glofitamab + Chemotherapy treatment unique for non-Hodgkin's lymphoma?
This treatment is unique because it combines glofitamab, a novel antibody targeting CD20 on B cells, with a chemotherapy regimen that includes carboplatin, etoposide, ifosfamide, and rituximab, which are known for their effectiveness in relapsed or refractory cases. The combination aims to enhance the immune system's ability to fight cancer cells while using chemotherapy to reduce tumor size.511121314
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
This trial is for people with a type of cancer called diffuse large B-cell lymphoma that has come back or didn't respond after their first treatment. They must have had therapy before that included an anti-CD20 antibody and anthracycline, be healthy enough to consider more intense treatments like stem cell transplant or CAR-T therapy, and not have certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 3 cycles of glofitamab, rituximab, ifosfamide, carboplatin, and etoposide (glofit-R-ICE)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Etoposide
- Glofitamab
- Ifosfamide
- Rituximab
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University