Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Michael J Dickinson, Carmelo Carlo-Stella, Franck Morschhauser...
https://pubmed.ncbi.nlm.nih.gov/36507690Actively Recruiting
Age: 18Years - 80Years
All Genders
ID06481826
A Study to Evaluate Glofitamab as Single Agent in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Led by Peking Union Medical College Hospital · Updated on 2026-03-27
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating glofitamab as a single treatment in Chinese patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have not responded to at least two previous systemic therapies. The study aims to assess the safety and effectiveness of this drug in managing this type of lymphoma. Participants will receive glofitamab at standard doses as the only treatment during the study. This observational study monitors patients over time without comparing to a placebo or other therapies. The focus is on how well the drug works and its safety in this specific patient group. During the study, researchers will follow patients for at least one year to measure progression-free survival. Additional outcomes include overall survival over two years, complete response rates at 6, 18, and 36 weeks, overall response rates at the same intervals, duration of response over two years, and adverse events over two years. Patients will undergo assessments to track disease status and treatment side effects throughout the study period.
CONDITIONS
Brief Title
Glofitamab in Chinese Patients With R/R DLBCL
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically-confirmed diffuse large B-cell lymphoma (DLBCL)
- Relapsed or refractory disease after failing at least two lines of prior systemic therapy
- Measurable disease present
You will not qualify if you...
- Pregnancy or breastfeeding
- Known active infection or reactivation of latent infection
- Active autoimmune disease or immune deficiency
- Severe organ failure including left ventricular ejection fraction below 40%, diffusion capacity of lung for carbon monoxide below 40%, estimated glomerular filtration rate below 30 ml/min, or bilirubin three times above upper limit of normal
- Dependence on the study sponsor, investigator, or trial site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration as per treatment protocol until disease progression or discontinuation
Participants receive Glofitamab as a single agent according to standard dosage.
Visits scheduled according to treatment cycles
Follow-up
Duration - Up to 2 years post-treatment
Participants are monitored for progression-free survival, overall survival, response rates, duration of response, and adverse events.
Periodic visits over 2 years
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
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Research Team
J
Jing Ruan
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Glofitamab in relapsed/refractory diffuse large B-cell lymphoma: Real-world data.
Elif Birtas Atesoglu, Zafer Gulbas, Ant Uzay...
https://pubmed.ncbi.nlm.nih.gov/37211991Glofitamab monotherapy induces high complete response rates and manageable safety in Chinese patients with heavily pretreated relapsed or refractory diffuse large B-cell lymphoma.
Yu-Qin Song, Hui-Lai Zhang, Hui-Qiang Huang...
https://pubmed.ncbi.nlm.nih.gov/37855035