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

NCT05018520 | Recruiting Phase 3 DMC

• 1 other identifier: HLK-C-2015
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse large B cell lymphoma; Side effects; Rituximab

Outcome Measures

Primary Outcomes (1)

• Progression of disease within 24 months

  Progression of disease within 24 months was defined as the rate of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.

  Baseline up to data cut-off (up to approximately 24 months)

Secondary Outcomes (4)

• Overall response rate

  t the end of Cycle 8 (each cycle is 21 days)

• Overall survival

  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

  Up to 30 days after completion of study treatment

• Quality of life of patients

  Up to 30 days after completion of study treatment

Study Arms (2)

4RCHOP+4R

EXPERIMENTAL

Four Courses of R-CHOP Plus Four Courses of Rituximab

Drug: Four Courses of R-CHOP Plus Four Courses of Rituximab

6RCHOP+2R

EXPERIMENTAL

Six Courses of R-CHOP Plus Two Courses of Rituximab

Drug: Six Courses of R-CHOP Plus Two Courses of Rituximab

Interventions

Four Courses of R-CHOP Plus Four Courses of Rituximab DRUG

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)

4RCHOP+4R

Six Courses of R-CHOP Plus Two Courses of Rituximab DRUG

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)

6RCHOP+2R

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Weili Zhao

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Xu

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director, Hematology Department

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 24, 2021
• Study Start: September 17, 2021
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)