Actively Recruiting
A Phase II Study of Chidamide with R-mini CHOP Followed by Chidamide Plus CD20 Maintenance in Elderly Patients with Newly Diagnosed MYC/BCL2 Double-Expressor Diffuse Large B-Cell Lymphoma
Led by Ou Bai, MD/PHD · Updated on 2026-03-25
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of chidamide combined with the R-mini CHOP regimen in elderly patients newly diagnosed with MYC/BCL2 double-expressor diffuse large B-cell lymphoma (DLBCL). The study focuses on the 2-year progression-free survival rate and also looks at response rates, duration of response, overall survival, and safety. Researchers will explore how biomarkers and circulating tumor DNA relate to treatment outcomes. Participants will receive chidamide orally at 20 mg twice a week for 14 days in each 21-day cycle alongside the R-mini CHOP chemotherapy regimen given every 3 weeks during the induction phase. Following this, a maintenance phase includes chidamide at the same dosing schedule combined with rituximab administered intravenously once every 12 weeks, continuing in 21-day cycles. The study is designed as a single-arm, open-label phase II trial. During the study, participants will undergo regular clinical evaluations, laboratory tests, and imaging scans such as PET-CT to monitor treatment response and safety over 24 months. Researchers will record objective response rates, complete response rates, and adverse events throughout. The study also involves biomarker and genomic analyses to assess correlations with treatment efficacy. Participants' overall survival and conversion rates from partial or stable disease to better responses will be closely followed.
CONDITIONS
Brief Title
Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older
- No prior treatment for diffuse large B-cell lymphoma (DLBCL)
- Histopathologically confirmed DLBCL, not otherwise specified, CD20-positive
- MYC expression ≥ 40% and BCL2 expression ≥ 50% by immunohistochemistry
- Not diagnosed with double-hit or triple-hit lymphoma
- At least one PET-CT positive lesion according to 2014 Lugano classification
- International Prognostic Index (IPI) score greater than 1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Laboratory values meeting specified hematology and biochemistry criteria unless due to lymphoma
- Life expectancy of at least 6 months
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Central nervous system involvement
- Transformed lymphoma from other lymphoma types or specific DLBCL subtypes such as primary CNS DLBCL
- Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infections
- History of severe allergic reactions to humanized or murine monoclonal antibodies or sensitivity to murine products
- Contraindications to any CHOP regimen component or chidamide
- HIV or hepatitis C virus infection
- Positive hepatitis B surface antigen with detectable HBV DNA
- Inability to comply with study protocol due to psychiatric or other reasons
- Unwillingness or inability to use effective contraception during and after treatment period
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by investigators for participation
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 - Induction: 4 cycles of 21 days each; Maintenance: cycles of 21 days with rituximab every 12 weeks
Participants receive chidamide combined with the R-mini CHOP regimen for induction, followed by chidamide plus CD20 (rituximab) maintenance.
Approximately 4 induction cycles with visits every 3 weeks, followed by maintenance visits every 3 weeks including rituximab infusions every 12 weeks
Duration - Up to 24 months
Participants are monitored for progression-free survival, response, overall survival, and safety for up to 24 months after treatment initiation.
Periodic visits as scheduled for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
Research Team
O
Ou Bai, PHD
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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