A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT07599423
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diffuse Large B Cell Lymphoma (DLBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obinutuzumab — DRUG
    A single 1000 mg dose is administered intravenously as pretreatment on Day 1 of Cycle 1 (7 days prior to the first glofitamab dose) to deplete peripheral B-cells and mitigate the risk of cytokine release syndrome (CRS).
  • Glofitamab — DRUG
    Glofitamab is administered intravenously using a step-up dosing schedule to mitigate CRS: Cycle 1 Day 8: 2.5 mg. Cycle 1 Day 15: 10 mg. Cycle 2-12 Day 1: 30 mg (target dose). Treatment continues for a maximum of 12 cycles (21-day cycles) or until disease progression/unacceptable toxicity.
  • Gemcitabine — DRUG
    Administered intravenously at 1000 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).
  • Oxaliplatin — DRUG
    Administered intravenously at 100 mg/m² on Day 2 of Cycle 1, and then on Day 1 or 2 of subsequent cycles (Cycles 2-8).
  • Salvage Chemotherapy (Investigator's Choice) — DRUG
    Participants in the SOC arm will receive up to 2 cycles of investigator's choice salvage therapy among the following regimens: ICE ± R, DHAP ± R, GDP ± R, ESHAP ± R, GemOx ± R, or MINE ± R .
  • Autologous Stem Cell Transplantation (ASCT) — DRUG
    Participants in the SOC arm who achieve a CR or PR after salvage therapy will proceed to ASCT. This includes a conditioning regimen (e.g., BEAM) followed by autologous stem cell rescue and a recovery period.

Study Details

The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).

Key Dates

First listed
May 20, 2026
Start date
Jul 22, 2026
Status verified
Jul 2026
Primary completion
Jul 21, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glofit-GemOx
  • Active Comparator: SoC

Primary Outcome Measure

Event-Free Survival (EFS) [ Time Frame: From randomization until the first occurrence of an EFS event (disease progression, new therapy, or death), assessed up to approximately 48 months. ]

Central Contacts

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