Actively Recruiting
The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
Led by Ruijin Hospital · Updated on 2026-05-11
640
Participants Needed
1
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study
CONDITIONS
Official Title
The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification with complete remission after 4 cycles of R-CHOP confirmed by PET-CT (Deauville score 1-2)
- Treatment naive patients
- International Prognostic Index (IPI) score of 0 or 1
- Age 14 to 75 years
- Non-mass lesions with length less than 7.5 cm
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy greater than 6 months
- Provided informed consent
You will not qualify if you...
- Prior systemic or local chemotherapy or treatment
- Previous autologous stem cell transplantation
- History of other malignant tumors except basal cell carcinoma of the skin and cervical cancer in situ
- Uncontrolled cardiovascular, cerebrovascular diseases, coagulopathy, connective tissue diseases, or severe infections
- Primary skin or central nervous system lymphoma
- Left ventricular ejection fraction less than 50%
- Any other uncontrolled medical condition affecting patient status as judged by researchers
- Abnormal laboratory values during screening not caused by lymphoma: neutrophils <1.510^9/L, platelets <8010^9/L, hemoglobin <100 g/L, ALT or AST twice the upper limit of normal, ALP and bilirubin 1.5 times above normal, creatinine 1.5 times above normal
- Psychiatric or other patients unable to follow study protocol
- Pregnant or lactating women
- Positive HBV surface antigen requiring negative HBV-DNA before inclusion; positive HBV core antibody requires HBV-DNA testing and treatment to negative before inclusion
- Patients living with HIV
- Patients with TP53 mutations or without DLBCL hot spot gene screening results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020
Actively Recruiting
Research Team
W
Weili Zhao
CONTACT
P
Pengpeng Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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