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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Weili Zhao
• Email: zwl_trial@163.com
• Phone: +862164370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL

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• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

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• Combining pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin for elderly diffuse large B‑cell lymphoma

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• Pola‑R‑GemOx chemotherapy for relapsed/refractory DLBCL in patients who cannot have an autologous transplant

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• Combining Loncastuximab and Roflumilast with R-CHOP for High-Risk Diffuse Large B-cell Lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.