Sponsor study identifier
interventional
40
1 country
1
Study Start
November 10, 2024
Actual (reported)Primary Completion
November 10, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 10, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 10, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2024
Actual (reported)November 10, 2024
Actual (reported)November 12, 2024
Actual (reported)November 10, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 10, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Complete remission rate(CRR)
The rate of patients who achieved CR after treatment with Glofitamab bridging ASCT Regimen
At the end of 3 months after ASCT
Main adverse reactions
Start from the first day of Immunotargeted therapy to 1 month after treatment with Glofitamab bridging ASCT Regimen
Overall response rate(ORR)
At the end of 3 months after ASCT.
2-year progression-free survival(PFS)
From enrollment to 2 year after the treatment of last patient
2-year overall survival(OS)
From enrollment to 2 year after the treatment of last patient
After at least second-line treatment, patients will be divided into three groups based on their disease status: Group A includes patients with partial response (PR) or ctDNA positivity who plan to receive ASCT or Glofitamab (specification: 10 mg per tube; dosage: 2.5 mg on day 8) as a bridge to ASCT; Group B includes patients with complete response (CR) and ctDNA negativity who will proceed directly to ASCT; Group C includes patients with stable or progressive disease (SD/PD) who will be assessed after two cycles of Glofitamab (Specification: 10mg per tube;Dosage: cycle 1: 2.5mg d8；10mg d15；cycle 2: 30mg d21). Those achieving PR will undergo ASCT, those with CR can choose ASCT or continue Glofitamab, and those with SD/PD will be removed from the group.
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.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
First Submitted
November 7, 2024
First Posted
November 12, 2024
Study Start
November 10, 2024
Actual (reported)Primary Completion
November 10, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Group B patients initiated ASCT treatment directly after evaluating the efficacy of salvage 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.
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Study Completion
November 10, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 14, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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