Glofitamab + Polatuzumab-R-CHP for Diffuse Large B-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of drugs to treat high-risk diffuse large B-cell lymphoma in patients who have not been treated before. The drugs help the immune system attack cancer and directly kill cancer cells. The standard treatment for diffuse large B-cell lymphoma (DLBCL) includes rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that prior use of certain treatments, like monoclonal antibodies or cytotoxic drugs, may affect eligibility. It's best to discuss your current medications with the trial team to get a clear answer.
Is the combination of Glofitamab and Polatuzumab-R-CHP safe for humans?
Polatuzumab vedotin, when used in combination with other drugs for treating diffuse large B-cell lymphoma, has shown an acceptable safety profile in clinical trials. Common side effects include blood-related issues like anemia (low red blood cell count) and neutropenia (low white blood cell count), but no fatal adverse events were observed.12345
What makes the drug combination of Glofitamab, Polatuzumab, and R-CHP unique for treating diffuse large B-cell lymphoma?
This drug combination is unique because it includes polatuzumab vedotin, an antibody-drug conjugate that targets CD79b on B-cells and delivers a toxin to kill cancer cells, and is combined with glofitamab, a novel bispecific antibody, and R-CHP chemotherapy, offering a new approach for patients with relapsed or refractory diffuse large B-cell lymphoma who have limited treatment options.23467
What data supports the effectiveness of the drug combination Glofitamab + Polatuzumab-R-CHP for treating Diffuse Large B-Cell Lymphoma?
Research shows that polatuzumab vedotin, part of the treatment, has demonstrated significant clinical efficacy in relapsed or refractory diffuse large B-cell lymphoma, leading to its FDA approval in combination with other drugs. Additionally, glofitamab, another component, has been studied for its survival outcomes in similar conditions, although it did not show a clear advantage over other treatments.24789
Who Is on the Research Team?
Jennifer Crombie, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults over 18 with untreated high-risk diffuse large B-cell lymphoma (DLBCL), a type of cancer. They must have an IPI score of 2-5, be in decent physical shape (ECOG 0-1-2), and their heart and other organs must work well. Women who can have babies and men must agree to use birth control. People with prior organ transplants, recent cancer treatments, or certain infections like HIV can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two cycles of polatuzumab-R-CHP and four cycles of glofitamab-polatuzumab-R-CHP, followed by two additional cycles of glofitamab alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Glofitamab
- Polatuzumab
- R-CHP
Glofitamab is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Philippe Armand, MD, PhD
Lead Sponsor
Jennifer Crombie, MD
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD