Glofit-GemOx + Liso-cel for Large B-Cell Lymphoma
(GLORY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a combination of treatments can benefit individuals with large B-cell lymphomas, a type of blood cancer that has returned or resisted previous treatments. The trial evaluates the treatment's effectiveness, duration of effects, and potential side effects. Participants will receive several medications, including the cell therapy lisocabtagene maraleucel, to determine if this approach is more effective than using the cell therapy alone. Individuals who have tried one unsuccessful treatment for their lymphoma and cannot undergo a stem cell transplant may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lisocabtagene maraleucel (liso-cel) is generally well-tolerated by patients. One study found it safe for individuals with B-cell cancers, such as large B-cell lymphoma. Some side effects, including cytokine release syndrome (which can cause fever and low blood pressure) and nerve damage, have been reported, but they are usually manageable.
Clear information on the safety of the Glofit-GemOx combination is not yet available. However, since this trial is in phase 2, earlier studies indicated it was safe enough to continue testing. Treatments in this phase are still being evaluated for efficacy and safety.
Overall, while some risks exist, previous studies suggest the treatments in this trial have potential safety. Participants should discuss all possible side effects with the trial staff to make an informed decision.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatment involving lisocabtagene maraleucel, or liso-cel, for large B-cell lymphoma because it offers a novel approach compared to standard therapies like R-CHOP or CAR T-cell therapies. Liso-cel is a type of CAR T-cell therapy that is engineered to target cancer cells more precisely, potentially leading to better outcomes. Additionally, the combination with Glofit-GemOx, a regimen including glofitamab, gemcitabine, and oxaliplatin, aims to enhance the body's immune response against the lymphoma. This unique combination of targeted cellular therapy and bridging chemotherapy could offer a more effective treatment option for patients who have not responded well to existing treatments.
What evidence suggests that this trial's treatments could be effective for large B-cell lymphoma?
Research has shown that lisocabtagene maraleucel (liso-cel), administered to participants after Glofit-GemOx bridging therapy, works well for patients with large B-cell lymphoma that has returned or not responded to other treatments. Studies found that 81.2% of patients had a positive reaction, and 71.3% showed no signs of cancer after treatment.
Glofitamab, combined with gemcitabine and oxaliplatin (Glofit-GemOx), also shows promise. Trials demonstrated that it helped patients live longer without cancer progression and achieved a 58.5% complete response rate, surpassing some standard treatments. This suggests that the combination of Glofit-GemOx followed by liso-cel could be a strong option for treating this type of lymphoma.678910Who Is on the Research Team?
Jeremy Abramson, MD, MMSc
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults with large B-cell lymphoma or similar B-cell lymphomas that have come back or not responded to previous treatments. Participants should be healthy enough for intensive therapy and meet specific health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Participants receive obinutuzumab infusion 3 days prior to leukapheresis
Leukapheresis and Bridging Therapy
Participants undergo leukapheresis followed by 1-2 cycles of Glofit-GemOx therapy
Lymphodepleting Chemotherapy
Participants receive lymphodepleting chemotherapy for 3 consecutive days
CAR-T Cell Therapy
Participants receive lisocabtagene maraleucel infusion 2-7 days after chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine
- Glofitamab
- Lisocabtagene maraleucel
- Lymphodepleting chemotherapy
- Obinutuzumab
- Oxaliplatin
Trial Overview
The study tests a treatment plan where patients first get obinutuzumab, then Glofitamab with gemcitabine and oxaliplatin (Glofit-GemOx), followed by chemotherapy to lower immune cells, and finally receive liso-cel cell therapy. The goal is to see if this sequence works better than liso-cel alone.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive obinutuzumab at the pre-determined dose 4 days prior to undergoing leukapheresis. After leukapheresis, participants will receive glofitamab, gemcitabine, and oxaliplatin (Glofit-GemOx) at the pre-determined doses over 3 weeks for 1-2 treatment cycles (each cycle is 21 days). Participants will then receive lymphodepleting chemotherapy of fludarabine and cyclophosphamide at the pre-determined doses for 3 consecutive days. Lsiocabtagene maraleucel (liso-cel) will be administered 2-7 days after the participants completes lymphodepleting chemotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
1.
conversations.advancedpractitioner.com
conversations.advancedpractitioner.com/resource-center/dlbcl/news/glofitamab-plus-gemcitabine-and-oxaliplatin-gemox-versus-rituximab-gemox-for-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-starglo-a-global-phase-3-randomised-open-label-trial/DLBCL Resource Center
Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma ...
2.
lymphomahub.com
lymphomahub.com/medical-information/glofit-gemox-vs-r-gemox-for-rr-dlbcl-results-from-phase-iii-starglo-trialGlofit-GemOx vs R-GemOx for R/R DLBCL: Results from ...
We summarize results from the STARGLO trial assessing the efficacy and safety of Glofit-GemOx vs R-GemOx in patients with R/R DLBCL, ...
3.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(26)04001-2/fulltextPatient-Reported Outcomes in Patients with Relapsed or ...
Glofit-GemOx-treated patients achieved clinically meaningful improvements in pain and lymphoma symptoms earlier (by Cycle 3) than R-GemOx- ...
NCT06806033 | Evaluate Optimization of CRS Profile for ...
This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin ...
Glofitamab with gemcitabine and oxaliplatin for treating ...
This evaluated the efficacy and safety of Glofit-. GemOx (n=183) compared with R-GemOx (n=91) in adults with relapsed or refractory DLBCL-NOS ...
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