NCT05018520RecruitingPhase 3
The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
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
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 640 (estimated)
- First submitted
- 11 Aug 2021
- Start date
- 17 Sept 2021
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Ruijin Hospital
- NCT number
- NCT05018520
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 640
- From 17 Sept 2021 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 14 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.