Compares two chemotherapy schedules for newly diagnosed low-risk lymphoma
Compares two chemotherapy schedules in people with newly diagnosed diffuse large B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 75 years old?
Source: NCT05018520, who can take part
Where in China
- Ruijin hospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT05018520
- Record updated
- 11 May 2026
- Original description
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 StudyRead full original descriptionShow less
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
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
Inclusion: Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT, Deauville score 1-2); Treatment naïve; IPI=0,1; Age ≥ 14 or ≤75 years; non-mass (The length of the lesion<7.5cm); ECOG=0,1; Life expectancy>6 months; Informed consented.
Exclusion: Have received systemic or local treatment including chemotherapy in the past; Have received autologous stem cell transplantation in the past; Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers decision; Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ; Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases; Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol; Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA is also required；if the result is positive, patients also need to be treated to become negative before entering the group; Patients living with HIV; Left ventricular ejection fraction ≦50%; Laboratory test value during screening: (unless it is caused by lymphoma) Neutrophils <1.5*109/L Platelet<80*109/L Hemoglobin <100g/L ALT or AST is 2 times higher than the upper limit of normal, AKP and bilirubin are 1.5 times higher than the upper limit of normal E. Creatinine level is higher than 1.5 times the upper limit of normal; Primary skin, primary central nervous system lymphoma; Pregnant or lactating women; Patients with TP53 mutations or those who have not undergone DLBCL hot spot gene screening.