RecruitingPhase 2NCT06682130

Glofitamab Bridging ASCT for Patients With Relapsed or Refractory DLBCL

A Prospective Study of Glofitamab Bridging Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma.


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

40 participants

Start Date

Nov 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called glofitamab (a bispecific antibody that helps immune cells attack lymphoma cells) can be used as a "bridge" to prepare patients for an autologous stem cell transplant (using their own cells) in people with relapsed or treatment-resistant diffuse large B-cell lymphoma (DLBCL). **You may be eligible if...** - You are between 18 and 70 years old and have confirmed DLBCL - Your cancer has come back or stopped responding after at least two rounds of treatment - You have not previously had a stem cell transplant - Your heart, liver, and kidneys are functioning adequately - You are in reasonable health (ECOG 0–1) **You may NOT be eligible if...** - You have had a prior stem cell transplant - You have active or uncontrolled infection, including HIV or hepatitis - Your organs are not functioning well enough to tolerate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGroup 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.

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

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

DRUGGroup 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.


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT06682130


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