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Glofitamab Bridging ASCT for Patients With Relapsed or Refractory DLBCL

NCT06682130 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-14

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy and safety of the Glofitamab bridging ASCT regimen in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and to provide better clinical benefits to these patients.

Conditions

  • Diffuse Large B-cell Lymphoma(DLBCL)

Interventions

DRUG

Group A：Patients with PR or ctDNA positivity after salvage treatment

1. Immunotargeted therapy * Ottuzumab introvenous infusion, 1000mg day1; * Glofitamab introvenous infusion Group A: 2.5mg day8 2. Autologous stem cell transplantation SEAM regimen * Simustine 250mg/m2 orally, day1 * Etoposide 200mg/m2 intravenous infusion, day2-5 * Cytarabine 400mg/m2 intravenous infusion, day2-5 * Metformin 140mg/m2 intravenous infusion, day6; Patients in Group A who intend to receive Glofitamab+ASCT will receive Glofitamab 2.5mg on day8 and start ASCT pretreatment on day15.

PROCEDURE

Group B: Patients with CR and ctDNA negative after salvage treatment

Group B patients initiated ASCT treatment directly after evaluating the efficacy of salvage treatment

DRUG

Group C: Patients with SD/PD after posterior treatment

1. Immunotargeted therapy * Ottuzumab introvenous infusion, 1000mg day1; * Glofitamab introvenous infusion Group C: cycle1 2.5mg day8, 10mg day15 cycle2 30mg day21 2. Autologous stem cell transplantation SEAM regimen * Simustine 250mg/m2 orally, day1 * Etoposide 200mg/m2 intravenous infusion, day2-5 * Cytarabine 400mg/m2 intravenous infusion, day2-5 * Metformin 140mg/m2 intravenous infusion, day6; After two treatment cycles with Glofitamab, patients in group C had a PET-CT to assess efficacy. Those with partial remission proceeded to ASCT consolidation, those with complete remission chose between ASCT or Glofitamab maintenance, and those with stable disease or progressive disease exited the trial.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2027-11-10
Completion
2029-11-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06682130 on ClinicalTrials.gov