Actively Recruiting
An Open-label, Single-arm, Single-center, Phase II Clinical Trial of Glofitamab Combination With Chidamide in Patients With Recurrent and Refractory Diffuse Large B-Cell Lymphoma
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-03-13
22
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Glofitamab and chidamide in adults aged 18 and older who have recurrent or refractory diffuse large B-cell lymphoma (DLBCL). This phase II, open-label, single-arm study aims to assess the feasibility, effectiveness, and safety of this combined treatment in patients who have already undergone other therapies. The trial is conducted at a single center and sponsored by Tianjin Medical University Cancer Institute and Hospital. Participants will receive Glofitamab and chidamide as a combination therapy. Glofitamab is administered via injection starting with 2.5 mg on day 8 and 10 mg on day 15 of the first 28-day cycle, followed by 30 mg every three weeks in cycles 2 through 12. Chidamide is taken orally at 30 mg twice weekly for 21 days in each treatment cycle. The study includes screening, treatment, and follow-up phases. During the trial, participants will be monitored through various assessments including evaluations of tumor response, safety, and survival outcomes. The primary outcome is the complete response rate after up to 12 cycles of treatment, with secondary outcomes including overall response rate, duration of response, progression-free survival, and overall survival, assessed over up to two years. Regular hospital visits, laboratory tests, and imaging will be part of the follow-up to track treatment effects and participant health throughout the study period, which ends in December 2028.
CONDITIONS
Brief 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 time of consent
- Willing and able to comply with hospitalization and study procedures
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL), including DLBCL-NOS, HGBCL, PMBCL, and FL transformed DLBCL
- Relapsed or refractory after at least two prior systemic therapies including anthracene and anti-CD20 regimens
- Measurable disease with lymphadenopathy >1.5 cm or extranodal lesion >1.0 cm
- Availability of neoplasm tissue specimen
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Resolution of prior treatment-related adverse events to grade 1 or less (except alopecia and hyporexia)
- Adequate liver, hematological, and renal function
- Negative pregnancy test for women of childbearing potential and agreement to use contraception
- Men agree to remain abstinent or use contraception
You will not qualify if you...
- Inability to comply with hospitalization or study restrictions
- Richter's transformation
- Active or recent major infections within 4 weeks prior to treatment
- Suspected or latent tuberculosis
- Positive chronic hepatitis B surface antigen or active hepatitis C infection
- Known HIV positive status
- Chronic active Epstein-Barr viral infection
- History of haemophagocytic lymphohistiocytosis
- Pregnancy, lactation, or planning pregnancy during and shortly after treatment
- Significant immune-related adverse events from prior therapies
- Refractory to Obinutuzumab monotherapy
- Active autoimmune disease requiring treatment
- Significant uncontrolled diseases affecting study adherence
- Severe allergy to monoclonal antibodies
- History of progressive multifocal leukoencephalopathy
- CNS lymphoma or other CNS diseases
- Other invasive malignancy within 2 years except certain skin cancers
- Serious cardiovascular conditions
- Live attenuated vaccine within 4 weeks prior to treatment
- Recent use of systemic tumor necrosis agents
- Substance abuse within 12 months
- Any condition contraindicating investigational drug use
- Mental or cognitive disorders limiting consent or compliance
- Other investigator-determined discomfort or risk factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28 days each
Participants receive combination therapy of Glofitamab and chidamide. Glofitamab is administered with a step-dose escalation regimen over 12 cycles, each cycle lasting 28 days. Chidamide is taken orally twice a week for 21 days per cycle.
Visits every 3 weeks for up to 12 cycles
Duration - Up to 2 years
Participants are monitored for response duration, progression-free survival, and overall survival up to 2 years after treatment completion.
Periodic visits during follow-up for up to 2 years
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
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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