GLORY: Study on Glofit-GemOx and Liso-Cel for Treating Lymphoma
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT07711483
This clinical trial is testing a new treatment approach for patients with large B-cell lymphomas that have returned or not responded to previous treatments. The study combines a chemotherapy and immunotherapy regimen (Glofit-GemOx) with a CAR-T cell therapy (liso-cel) to see if this combination is more effective than liso-cel alone.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well a combination of treatments, including Glofit-GemOx and liso-cel, works for patients with large B-cell lymphomas that have come back or not responded to previous treatments. Researchers want to know if this combination can improve treatment outcomes, such as how long the effects last and overall survival rates, compared to using liso-cel alone. The study will also look at the safety of this treatment combination and monitor any side effects experienced by participants.
Description
This study involves a combination of treatments for patients with large B-cell lymphomas that have returned or not responded to previous treatments. Participants will first receive an infusion of obinutuzumab, a drug that helps the immune system target cancer cells. Then, they will undergo a procedure called leukapheresis to collect their T cells. After this, participants will receive 1-2 cycles of Glofit-GemOx therapy, which includes the drugs glofitamab, gemcitabine, and oxaliplatin. These drugs work together to help the immune system attack cancer cells and stop them from growing.
Following the Glofit-GemOx therapy, participants will receive chemotherapy to prepare their body for the next step, which is an infusion of liso-cel. Liso-cel is a CAR-T cell therapy made from the participant's own T cells, which have been modified to better recognize and attack cancer cells. The study will monitor participants for up to 24 months to assess the effectiveness and safety of this treatment combination.
About 52 people are expected to participate in this study, which is supported by Bristol Myers Squibb Company.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with specific types of large B-cell lymphoma, including diffuse large B-cell lymphoma and other related subtypes.
- The lymphoma must have returned or not responded to at least one previous treatment that included a CD20-targeted agent and an anthracycline or alkylating agent.
- Eligible for treatment with lisocabtagene maraleucel (liso-cel).
- Adults aged 18 years or older.
- Have measurable disease as determined by specific medical criteria.
- Have a performance status score of 0 to 2, indicating good overall health.
- Meet specific blood test criteria for kidney and liver function.
- Agree to use effective contraception during the study and for 12 months after treatment.
- Willing to participate in all study procedures and provide informed consent.
Exclusion Criteria
- History of other cancers that could interfere with the study.
- Severe or uncontrolled medical conditions that make participation unsafe.
- Previous treatment with CAR T-cell therapy or certain other antibody therapies.
- Active infections, including hepatitis B or C, or HIV with a positive viral load.
- Pregnant or breastfeeding women.
- Use of certain medications or treatments within a specified time before the study.
- Participation in another clinical trial at the same time.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
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