Study on Using Cema-cel for Patients with Large B-Cell Lymphoma in Minimal Residual Disease Remission
Sponsor: Allogene Therapeutics
ClinicalTrials ID:NCT06500273
This clinical trial is testing a new treatment called cema-cel for patients with large B-cell lymphoma (LBCL) who have responded to initial therapy but still have minimal residual disease (MRD). The study aims to see if cema-cel can help improve outcomes compared to just monitoring the disease.
Patient Parameters
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Program Overview
This study is for adults with large B-cell lymphoma (LBCL) who have completed their first round of standard treatment and have shown a complete or partial response, but still have minimal residual disease (MRD) detected by a special test. The trial will compare the effectiveness and safety of a new treatment called cema-cel, a type of CAR T-cell therapy, against the standard approach of observing the disease without additional treatment. The study is divided into two parts: Part A will test different treatment regimens to find the best one, and Part B will compare the selected regimen with standard observation.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with large B-cell lymphoma, including specific subtypes confirmed by a pathology report.
- Completed a full course of standard first-line therapy for LBCL.
- Achieved a complete or partial response suitable for observation after initial therapy, as shown by PET/CT scans.
- Tested positive for minimal residual disease (MRD) using the Foresight CLARITY™ test.
- Adults aged 18 years or older.
- Good overall health with an ECOG performance status of 0 or 1.
- Adequate blood, kidney, liver, lung, and heart function.
- Any side effects from previous treatments must have improved to baseline levels or be mild.
Exclusion Criteria
- History of LBCL affecting the central nervous system or transformed from another type of cancer.
- Previous treatment with therapies targeting CD19.
- Received any cancer treatment, including radiation, after the end of initial therapy and MRD testing.
- Have an active and significant autoimmune disease.
- Have active infections requiring treatment, such as HIV.
- Have had another primary cancer or bone marrow disorder within the last 3 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alta Bates Summit Medical Center | 94704 | Berkeley | California |
| City of Hope | 91010 | Duarte | California |
| Cedars-Sinai Medical Center | 90048 | Los Angeles | California |
| University of California, Davis Comprehensive Cancer Center | 91817 | Sacramento | California |
| Rocky Mountain Cancer Centers | 80218 | Denver | Colorado |
| Medical Oncology Hematology Consultants | 19713 | Newark | Delaware |
| Miami Cancer Institute at Baptist Health, Inc. | 33176 | Miami | Florida |
| Advent Health Cancer Institute | 32804 | Orlando | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Indiana Blood and Marrow Transplantation | 46237 | Indianapolis | Indiana |
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