Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
- Sponsor
- Zhengzhou University
- Study ID
- NCT06956092
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- B Cell Lymphoma (BCL)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Glofitamab treatment — BIOLOGICALeceive Glofitamab treatment as per the instructions in the package insert.
Study Details
The goal of this clinical trial is to learn if Glofitamab works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of Glofitamab treatment. The main questions it aims to answer are: * Does Glofitamab treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment? * What medical problems do participants have when receiving Glofitamab treatment? In this investigator-initiated, single-arm clinical trial, participants will: * Receive Glofitamab treatment as per the instructions in the package insert. * Visit the clinic as instructed for checkups and tests.
Key Dates
- Start date
- May 30, 2025
- Status verified
- Apr 2025
- Primary completion
- Jun 30, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental: Glofitamab treatment
Primary Outcome Measure
two year PFS [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
Central Contacts
- Zhang, PhD86-0371-66279567