NCT05018520 The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
| NCT ID | NCT05018520 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ruijin Hospital |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 640 participants |
| Start Date | 2021-09-17 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 640 participants in total. It began in 2021-09-17 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Have received systemic or local treatment including chemotherapy in the past * Have received autologous stem cell transplantation in the past * 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 * Primary skin, primary central nervous system lymphoma * Left ventricular ejection fraction ≦50% * Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers decision * 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 * Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol * Pregnant or lactating women * 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 * Patients with TP53 mutations or those who have not undergone DLBCL hot spot gene screening
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05018520 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 75 Years, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05018520 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 640 participants.
Is NCT05018520 currently recruiting?
Yes, NCT05018520 is actively recruiting participants. Contact the research team at zwl_trial@163.com for enrollment information.
Where is the NCT05018520 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05018520 clinical trial?
NCT05018520 is sponsored by Ruijin Hospital. The trial plans to enroll 640 participants.