Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell Lymphomas

Sponsor
American University of Beirut Medical Center
Study ID
NCT07387848
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diffuse Large B Cell Lymphoma Refractory

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    Glofitamab is started with initially a step-up dosing of 2.5 mg on C1D1 then 10 mg on C1D8 to be followed by 30 mg every 3 weeks for a total of 3 cycles. Disease evaluation is repeated after completion of 3 cycles of Glofitamab, and patients achieving PR or better then undergo ASCT followed by 3 cycles post consolidation glofitamab (30 mg every 3 weeks).

Study Details

This is an investigator-initiated, open-label, single-arm, multicenter, Phase II clinical study. The study is designed to evaluate the safety and potential effectiveness of glofitamab in adults with their disease, diffuse large B-cell lymphoma (DLBCL has either not responded to initial treatment or has returned after an initial response and who are eligible and medically fit for autologous stem cell transplantation (ASCT). Autologous stem cell transplantation is a commonly used treatment in this situation and involves high-dose chemotherapy followed by infusion of your own stem cells, which are collected from your blood several weeks before the transplant. The purpose of this study is to assess glofitamab, which is not part of standard treatment. Glofitamab is a type of antibody designed to attach to both lymphoma cells and certain immune cells called T cells. By bringing these cells together, glofitamab may help activate the immune system so that T cells can better recognize and destroy lymphoma cells. In this study, glofitamab may be used as a "bridge" to transplantation and/or as consolidation treatment after the transplant, depending on how the disease responds to chemotherapy given before the transplant. In recent years, newer immune-based treatments such as CAR-T cell therapy have shown benefit for patients whose lymphoma does not respond to or returns after chemotherapy. CAR-T therapy involves collecting immune cells, modifying them in a laboratory, and then reinfusing them into the patient. However, access to CAR-T therapy is limited in some regions, including Lebanon, and autologous stem cell transplantation remains an important treatment option

Key Dates

Start date
Apr 15, 2026
Status verified
Jan 2026
Primary completion
Dec 15, 2031
Completion
Dec 15, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single arm study assessing the efficacy and safety of Glofitamab as a bridge to and/or consolidation
    Participants who complete two cycles of Rituximab-chemotherapy will undergo evaluation by PET scan. * Complete responders will proceed to a third cycle of Rituximab-chemotherapy, followed by autologous stem cell transplantation (ASCT) and six cycles of consolidation Glofitamab. * Participants with an incomplete response will receive three cycles of salvage Glofitamab, after which they will be re-evaluated by PET scan. Patients achieving a complete response at this stage will proceed to ASCT, followed by three cycles of consolidation Glofitamab. Non-responders will be discontinued from the study

Primary Outcome Measure

To evaluate the efficacy of glofitamab when used as a bridge to and/or consolidation post-transplant for patients with relapsed/refractory B-cell lymphomas (DLBCL or transformed low grade B cell lymphoma) fit and eligible for ASCT [ Time Frame: 3 years ]

Central Contacts

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