Clinical trial NCT05018520: The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Diffuse large B cell lymphoma
Side effects
Rituximab
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 800
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Diffuse large B cell lymphoma (DLBCL) is the subtype with the highest incidence, accounting for 35.8% of B cell lymphoma. 6 to 8 cycles of R-CHOP regimen is currently the standard first-line regimen for DLBCL, however, the side effects including nausea, vomiting, neutropenia, hair loss, and heart failure can decrease the life quality and are sometimes life threatening. Recently, domestic and foreign scholars have been committed to reduce the dose of chemotherapy and improve the quality of life in low-risk patients. This study uses 4 courses of R-CHOP plus 4 courses of R (4+4 plan) versus 6 courses of R-CHOP plus 2 courses of R (6+2 plan) for the treatment of newly treated, low-risk, non-mass DLBCL patients. The promising result will create a new model for the treatment and improve the life quality of low-risk DLBCL.

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

Primary outcomes:
measure: Progression of disease within 24 months
timeFrame: Baseline up to data cut-off (up to approximately 24 months)
Secondary outcomes:
measure: Overall response rate
timeFrame: t the end of Cycle 8 (each cycle is 21 days)
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Up to 30 days after completion of study treatment
measure: Quality of life of patients
timeFrame: Up to 30 days after completion of study treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References: