Recruiting NCT05018520

The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk

Phase III Interventional Diffuse Large B Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Six Courses of R-CHOP Plus Two Courses of Rituximab, Four Courses of R-CHOP Plus Four Courses of Rituximab.
Who it may be relevant to: Registry conditions: Diffuse Large B Cell Lymphoma. Basic parameters: 14 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

Drug Six Courses of R-CHOP Plus Two Courses of Rituximab
The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 21 days for total 2 courses)
Drug Four Courses of R-CHOP Plus Four Courses of Rituximab
The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 4 courses) followed by Rituximab (375mg/m2 d1, every 21 days for total 4 courses)

Primary outcome measures

Progression of disease within 24 months [Time frame: Baseline up to data cut-off (up to approximately 24 months)]

Secondary outcome measures (4)

Overall response rate [Time frame: t the end of Cycle 8 (each cycle is 21 days)]
Overall survival [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [Time frame: Up to 30 days after completion of study treatment]
Quality of life of patients [Time frame: Up to 30 days after completion of study treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 1 center

Ruijin Hospital — Shanghai

Identifiers

NCT: NCT05018520 · HLK-C-2015

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗