40
Participants
Start Date
November 10, 2024
Primary Completion Date
November 10, 2027
Study Completion Date
November 10, 2029
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."
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
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."
RECRUITING
The First Affiliated Hospital of Soochow University, Suzhou
The First Affiliated Hospital of Soochow University
OTHER