Actively Recruiting
Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-03-13
22
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent/refractory diffuse large B-cell lymphoma.
CONDITIONS
Official Title
Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older at the time of consent
- Willing and able to comply with hospitalization and study procedures after Glofitamab administration
- Histologically confirmed DLBCL diagnosis including DLBCL-NOS, HGBCL, PMBCL, or transformed follicular lymphoma
- Relapsed or refractory after at least two prior systemic therapies including anthracycline and anti-CD20 treatments
- Measurable disease with lymphadenopathy or extranodal lesions of specified size
- Availability of neoplasm tissue samples or biopsy specimens
- ECOG performance status of 0 or 1
- Life expectancy of 12 weeks or more
- Prior adverse events from treatment resolved to grade 1 or less (except alopecia and hyporexia)
- Adequate liver function with specified bilirubin and enzyme levels
- Adequate hematologic function with specified neutrophil, platelet, and hemoglobin counts
- Adequate renal function with specified creatinine or clearance levels
- Negative pregnancy test within 7 days for women of childbearing potential; agreement to use contraception or abstain from heterosexual intercourse for men and women of childbearing potential
You will not qualify if you...
- Unable to comply with hospitalization and study restrictions
- Richter's transformation
- Active infections including bacterial, viral, fungal, mycobacterial, parasitic, or major infections within 4 weeks prior to treatment
- Suspected or latent tuberculosis disease
- Positive test for chronic hepatitis B infection
- Positive hepatitis C antibody test or active HCV RNA
- Known HIV positive status
- Known or suspected chronic active Epstein-Barr virus infection
- History or suspicion of haemophagocytic lymphohistiocytosis
- Pregnancy, lactation, or planning pregnancy during and shortly after treatment
- Severe immunization related adverse events from prior treatments
- Documented refractory to Obinutuzumab monotherapy
- Active autoimmune disease requiring treatment
- Significant uncontrolled diseases affecting study adherence or results
- History of severe allergic reactions to monoclonal antibodies
- History of progressive multifocal leukoencephalopathy
- Current or past central nervous system lymphoma or disease
- Other invasive malignancies within 2 years, except certain skin cancers
- Serious or unstable heart conditions
- Recent live attenuated vaccine administration or planned live vaccines during study
- Recent use of systemic tumor necrosis agents except allowed corticosteroids
- History of illicit drug or alcohol abuse within 12 months
- Any other condition that contraindicates investigational drug use
- Mental or cognitive disorders limiting consent or study compliance
- Other investigator-assessed conditions causing discomfort or ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
H
Huilai Zhang
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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