Comparing two treatment regimens for low-risk diffuse large B cell lymphoma

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

This study is testing two different treatment plans for people with low-risk diffuse large B cell lymphoma to see which one works better and causes fewer side effects.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 640 (estimated)
• Ages: 14 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: chemotherapy, Rituximab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05018520 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of two different treatment regimens for newly diagnosed patients with low-risk diffuse large B cell lymphoma (DLBCL). It compares a regimen of four courses of R-CHOP plus four courses of Rituximab against the standard six courses of R-CHOP plus two courses of Rituximab. The goal is to reduce side effects while maintaining treatment efficacy, thereby improving the quality of life for patients. The study is a multi-center, prospective, randomized controlled trial designed to provide robust data on the outcomes of these treatment approaches.

Who should consider this trial

Good fit: Ideal candidates for this study are treatment-naïve patients aged 14 to 75 with pathologically confirmed CD20 positive DLBCL who have a low International Prognostic Index (IPI) score.

Not a fit: Patients with a history of other malignancies, uncontrolled cardiovascular diseases, or those who have previously received chemotherapy or stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a less intensive treatment regimen that minimizes side effects for patients with low-risk DLBCL.

How similar studies have performed: Previous studies have explored dose-reduction strategies in DLBCL treatment, indicating potential for success, but this specific comparison of regimens is novel.

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

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Weili Zhao

Conditions: Diffuse Large B Cell Lymphoma, Diffuse large B cell lymphoma, Side effects, Rituximab