Actively Recruiting
Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-07-23
22
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To prospectively evaluate the efficacy and safety of large fraction radiation therapy combined with granulocyte-macrophage colony-stimulating factor, lenalidomide, and glofitamab monoclonal antibody in the treatment of refractory relapsed diffuse large B-cell lymphoma patients
CONDITIONS
Official Title
Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any trial procedures
- Be 18 years or older of any gender with expected survival over 3 months
- Have an ECOG performance status score between 0 and 3
- Have histopathologically confirmed diffuse large B-cell lymphoma
- Have relapsed or refractory disease after first-line treatment or multiple systemic therapies, including those with central nervous system metastasis
- Have not previously received bispecific antibody therapy
- Have at least one measurable lesion according to RECIST1.1 criteria
- Have sufficient organ function based on specific laboratory criteria for liver, kidney, and coagulation
- For women of childbearing potential, have a negative pregnancy test within 3 days before starting the study drug
- Agree to use effective contraception during treatment and for 120 days after last study drug administration if at risk of pregnancy
You will not qualify if you...
- B-cell non-Hodgkin's lymphoma with loss of CD20 expression
- Active hepatitis B or C infection with specific viral load thresholds
- Received anti-hematologic malignancy treatment within 2 weeks or 5 drug half-lives before treatment start
- Bone marrow insufficiency with low platelet or neutrophil counts
- Clinically significant pulmonary disease including severe COPD or uncontrolled asthma
- Uncontrolled hypertension despite treatment
- Symptomatic congestive heart failure or certain heart rhythm abnormalities
- Received large fraction radiation therapy within 4 weeks before starting treatment unless no radiation-related toxic effects remain
- Difficulty swallowing oral medications
- History of significant lung diseases such as pulmonary fibrosis or drug-related pneumonia
- HIV infection or known syphilis infection
- Presence of unhealed wounds, ulcers, or gastrointestinal conditions that may cause bleeding or perforation
- Active or uncontrolled severe infections within 4 weeks before treatment
- Recent major surgery or significant injury within 4 weeks before treatment
- Use of traditional Chinese medicine with anti-tumor effects within 2 weeks before treatment
- Known allergy to bispecific antibodies or GM-CSF components
- Participation in another clinical trial within 4 weeks before treatment
- Pregnant or breastfeeding women
- Active or history of autoimmune diseases requiring systemic treatment, except certain controlled conditions
- Other acute or chronic illnesses or abnormal lab results that increase risk or interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
Z
Zhijuan Lin, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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