Study on Epcoritamab with Chemotherapy and Stem Cell Transplant for Treating Relapsed or Resistant Large B-cell Lymphoma

Sponsor: University of California, Davis

Sponsor score: 0

ClinicalTrials ID:NCT06905509

This clinical trial is exploring a new treatment approach using epcoritamab combined with standard chemotherapy and a stem cell transplant to treat patients with large B-cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Parameter	Options

Program Overview

This study aims to find out if combining epcoritamab with standard chemotherapy and a stem cell transplant can effectively treat large B-cell lymphoma (LBCL) that has come back or not responded to earlier treatments. Epcoritamab is a drug that helps the immune system target and kill cancer cells. The chemotherapy drugs used in this study work by stopping cancer cells from growing and spreading. The stem cell transplant involves collecting and storing a patient's own blood-forming cells and then giving them back after treatment to help the body recover.

Description

The main goal of this study is to see how well the combination of epcoritamab, chemotherapy, and stem cell transplant works in shrinking tumors in patients with relapsed or resistant large B-cell lymphoma (LBCL). Researchers will also look at the side effects of this treatment.

Treatment Plan:

Before Stem Cell Transplant: Patients will receive epcoritamab injections under the skin on specific days of each treatment cycle. They may also receive chemotherapy drugs like rituximab, cytarabine, dexamethasone, oxaliplatin, or carboplatin, depending on their treatment plan.
Stem Cell Transplant: Patients will undergo a procedure to receive their own stem cells back into their body.
After Stem Cell Transplant: Patients will continue to receive epcoritamab injections on a set schedule for up to 12 cycles, as long as the disease does not progress and side effects are manageable.

Throughout the study, patients will have regular check-ups, including heart scans, blood tests, and imaging tests like CT or PET scans to monitor their health and the treatment's effectiveness. After completing the study treatment, patients will have follow-up visits for up to two years.

Eligibility Criteria

Inclusion Criteria

Must have a confirmed diagnosis of relapsed or resistant large B-cell lymphoma (LBCL).
- This includes specific types like diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and transformed follicular lymphoma.
Must have previously received standard chemotherapy but the disease returned or did not respond.
Must be eligible for platinum-based chemotherapy and stem cell transplant.
Must be in good overall health with a performance status score of 0 to 2.
Must have measurable disease on scans.
Must be 18 years or older.
Must have adequate kidney and liver function.
Must have sufficient blood cell counts.
Must agree to use effective birth control during the study and for 12 months after the last dose of epcoritamab.
Must provide signed informed consent.

Exclusion Criteria

Any unresolved side effects from previous lymphoma treatment.
Uncontrolled illness or active infections.
Active central nervous system involvement unless in complete remission.
Previous treatment with similar drugs or investigational treatments recently.
Significant heart disease or recent heart attack or stroke.
Pregnant or breastfeeding women.
History of other cancers unless treated and in remission for at least 3 years.
Active hepatitis B or C, or HIV infection unless well-controlled.
Autoimmune diseases requiring ongoing immunosuppressive therapy.
Recent live vaccinations.
Planning to donate sperm or conceive a child during the study or within 12 months after treatment.

Locations

FACILITY	ZIP	CITY	STATE
University of California Davis Comprehensive Cancer Center	95817	Sacramento	California

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.