Actively Recruiting
Chidamide Plus R-CHOP (CR-CHOP) in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes: A Prospective, Multicenter Phase II Trial
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-03-24
148
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a treatment combining chidamide with R-CHOP chemotherapy in patients newly diagnosed with double-expressor diffuse large B-cell lymphoma (DEL-DLBCL) of the Other molecular subtype. This subtype has been linked to poorer survival outcomes, and previous trials suggested that chidamide plus R-CHOP might improve response rates and event-free survival in DEL patients. This study is a phase II trial aiming to confirm these findings specifically in patients with the Other molecular subtype of DEL-DLBCL. The treatment being studied is a combination of chidamide and R-CHOP, which includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Participants will receive this combined therapy as their initial treatment. The study involves up to six cycles of treatment, each lasting 21 days. This approach is designed to assess the complete response rate and other outcomes over the course of treatment. Participants will be closely monitored throughout the study, which includes evaluations through imaging tests like CT or MRI to measure tumor lesions. Researchers will track progression-free survival over two years as the main outcome. Additional assessments include overall survival and objective response rate up to six treatment cycles. Safety, liver and kidney function, and patient consent will be carefully observed. The total study duration and follow-up extend to at least two years to evaluate long-term treatment effects and patient outcomes.
CONDITIONS
Brief Title
Chidamide Plus R-CHOP in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with diffuse large B-cell lymphoma by pathology according to WHO 2016 criteria
- Molecular subtype classified as "Other" by high-throughput sequencing
- Overexpression of MYC (≥40%) and BCL2 (≥50%) by immunohistochemistry
- Measurable lesions on CT or MRI with at least one lesion ≥1.5 cm in diameter
- ECOG performance status score of 2 or less
- Adequate liver and kidney function as defined by specified laboratory limits
- Willing to participate and provide signed informed consent
You will not qualify if you...
- Currently enrolled in another clinical trial
- Prior lymphoma treatment with other regimens
- Presence of other active malignant tumors
- Deemed ineligible by investigator judgment
- Severe psychiatric or neurological disorders affecting consent or safety
- Unable to comply with follow-up requirements
- Pregnant or breastfeeding women, or those unwilling to use contraception
- Active infection or uncontrolled hepatitis B or hepatitis C virus infection
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 6 cycles (each cycle is 21 days)
Participants receive Chidamide plus R-CHOP drug regimen treatment for diffuse large B-cell lymphoma.
Up to 6 treatment visits (in-person)
Duration - Up to 2 years
Participants are monitored for progression-free survival and overall survival for up to 2 years after treatment.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
W
Wei Xu, Doctor
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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