Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma (NCT06956092) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
China40 participantsStarted 2025-05-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Understand and voluntarily sign the informed consent form.
. Age 18-75 years (inclusive, including 18 and 75 years) at screening; no restriction on gender.
. Diagnosed with B-cell non-Hodgkin lymphoma according to the 2022 WHO Classification of Tumors of Hematopoietic and Lymphoid Tissues (5th edition). The following subtypes are included in this trial:
Exclusion criteria
. History of severe allergy or hypersensitivity reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
. Received autologous hematopoietic stem cell transplantation (ASCT) within 100 days prior to the first dose of Glofitamab; received chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to the first dose of Glofitamab.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
two year PFS
Timeframe: 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
. History of acute or chronic active hepatitis B or hepatitis C infection. Patients with a history of hepatitis must demonstrate viral clearance based on standard serological and genetic testing (i.e., hepatitis B surface antibody positive, other markers negative, and HBV DNA PCR negative) to be eligible; other cases require approval from the medical monitor.
. Infection with human immunodeficiency virus (HIV).
. Known or suspected chronic active Epstein-Barr virus (CAEBV) infection.
. Presence of uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding nail bed fungal infections) at screening or occurrence of any serious infection within 4 weeks prior to the first infusion of Glofitamab (as judged by the investigator).