Study on Epcoritamab, Rituximab, Gemcitabine, and Oxaliplatin for Treating Relapsed or Hard-to-Treat Diffuse Large B-Cell Lymphoma
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT07365306
This clinical trial is testing a combination of drugs, including Epcoritamab, Rituximab, Gemcitabine, and Oxaliplatin, to see if they can help treat patients with Diffuse Large B-Cell Lymphoma (DLBCL) that has returned or is not responding to treatment. The study aims to find out if this combination can prepare patients for a stem cell transplant.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well a combination of drugs—Epcoritamab, Rituximab, Gemcitabine, and Oxaliplatin—works as a treatment for patients with Diffuse Large B-Cell Lymphoma (DLBCL) that has come back or is not responding to other treatments. This treatment is given before a stem cell transplant to help kill cancer cells and make room for new healthy cells to grow. Epcoritamab is a special type of antibody that helps the immune system target and destroy cancer cells. Rituximab is another antibody that works similarly. Gemcitabine and Oxaliplatin are chemotherapy drugs that help stop cancer cells from growing.
Description
The main goal of this study is to see how many patients with relapsed or hard-to-treat DLBCL achieve a complete response after receiving the combination of Epcoritamab, Rituximab, Gemcitabine, and Oxaliplatin. Researchers will also look at the overall response rate, how many patients can successfully undergo a stem cell transplant, and how long patients live without the cancer getting worse. The study will also evaluate the safety of the treatment and any side effects.
Patients will receive the combination treatment in cycles, with Epcoritamab given as an injection and the other drugs given through an IV. If the cancer responds well, patients may receive additional cycles of treatment. After the initial treatment, patients may undergo a stem cell transplant. If they cannot have a transplant, they may receive additional Epcoritamab treatment.
Throughout the study, patients will have regular blood tests, scans, and possibly biopsies to monitor their response to the treatment. After completing the study treatment, patients will have follow-up visits to check their health and the status of their cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) or related subtypes.
- The cancer must have returned or not responded to at least one previous treatment.
- Must have measurable disease on scans.
- Must be eligible for high-dose chemotherapy and a stem cell transplant.
- Must have good overall health with an ECOG performance status of 0 to 2.
- Must have adequate blood counts and organ function.
- Must agree to use effective birth control during the study and for a specified time after treatment.
- Must not have active infections like HIV, hepatitis B, or hepatitis C unless well-controlled.
- Women must not be pregnant and must have a negative pregnancy test before starting treatment.
Exclusion Criteria
- Have had a stem cell transplant within the past year.
- Have received certain treatments or surgeries recently.
- Have active infections or other serious medical conditions.
- Have a history of severe allergic reactions to similar treatments.
- Have uncontrolled heart or liver disease.
- Are pregnant or breastfeeding.
- Are unable to tolerate injections or comply with study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| City of Hope Atlanta Cancer Center | 30265 | Newnan | Georgia |
| City of Hope at Chicago | 60099 | Zion | Illinois |
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