Diffuse Large B Cell LymphomaPhase 3NCT05018520
The Safety and Effectiveness of 4R-CHOP+4R vs 6R-CHOP+2R in Newly Diagnosed Patients With DLBCL in Low Risk
A Phase 3 study testing Six Courses of R-CHOP Plus Two Courses of Rituximab and Four Courses of R-CHOP Plus Four Courses of Rituximab in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Six Courses of R-CHOP Plus Two Courses of Rituximab and Four Courses of R-CHOP Plus Four Courses of Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2021to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200020
Weili Zhao, +862164370045 ext. 610707, zwl_trial@163.com
About this study
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
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
Read the 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.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Six Courses of R-CHOP Plus Two Courses of Rituximab, Four Courses of R-CHOP Plus Four Courses of Rituximab
- Keywords
- Diffuse large B cell lymphoma, Side effects, Rituximab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six Courses of R-CHOP Plus Two Courses of RituximabDrug
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)
Four Courses of R-CHOP Plus Four Courses of RituximabDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 4RCHOP+4R | Experimental | Four Courses of R-CHOP Plus Four Courses of Rituximab Receives: Drug: Four Courses of R-CHOP Plus Four Courses of Rituximab |
| 6RCHOP+2R | Experimental | Six Courses of R-CHOP Plus Two Courses of Rituximab Receives: Drug: Six Courses of R-CHOP Plus Two Courses of Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to data cut-off (up to approximately 24 months)
Secondary outcomes (4)
Overall response rate
Percentage of participants with overall response examined by PET-CT was determined on the basis of investigator assessments according to 2014 Lugano criteria
Measured: t the end of Cycle 8 (each cycle is 21 days)
Overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Measured: 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
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events
Measured: Up to 30 days after completion of study treatment
Quality of life of patients
Quality of life of patients estimated by European organization for Research and Treatment of Cancer (EORCT) QLQ一C30 by the researchers
Measured: Up to 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start17 Sep 2021
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018520
- Sponsor's protocol ID
- HLK-C-2015
- Status last verified
- May 2026
- First submitted
- 11 Aug 2021
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05018520
- Acronym / sponsor ID
- HLK-C-2015
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Diffuse large B cell lymphoma, Side effects, Rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4RCHOP+4R | Experimental | Drug: Four Courses of R-CHOP Plus Four Courses of RituximabFour Courses of R-CHOP Plus Four Courses of Rituximab |
| 6RCHOP+2R | Experimental | Drug: Six Courses of R-CHOP Plus Two Courses of RituximabSix Courses of R-CHOP Plus Two Courses of Rituximab |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six Courses of R-CHOP Plus Two Courses of RituximabThe 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 | 6RCHOP+2R |
| Four Courses of R-CHOP Plus Four Courses of RituximabThe 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) | Drug | 4RCHOP+4R |
Primary outcome
Progression of disease within 24 months
Time frame: Baseline up to data cut-off (up to approximately 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Six Courses of R-CHOP Plus Two Courses of Rituximab and Four Courses of R-CHOP Plus Four Courses of Rituximab in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of disease within 24 months (time frame: Baseline up to data cut-off (up to approximately 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.