Comparing R-CMOP and R-CHOP for treating diffuse large B-cell lymphoma
Official title: Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of Low-risk and Medium-risk Diffuse Large B-cell Lymphoma (DLBCL): a Randomized, Controlled, Open-label, Multicenter, Phase Ib/II Clinical Study
Run by Sun Yat-sen University · NCT06760039 · Data updated 2026-11-12
This study is testing which treatment, R-CMOP or R-CHOP, works better and is safer for adults with low-risk and medium-risk diffuse large B-cell lymphoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 10 sites (Fuzhou, Fujian and 9 other locations) |
| Status | Recruiting |
| Started | January 10, 2025 |
| Main results expected | August 31, 2028 |
| Study ends | November 30, 2028 |
| Registry record updated | April 3, 2025 |
| Trial ID | NCT06760039 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 80 with newly diagnosed, pathologically confirmed DLBCL and an International Prognostic Index score of 2 or lower.
✕Probably not a fit
Patients with other types of large B-cell lymphomas or those who have previously received treatment for DLBCL will not benefit from this study.
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 efficacy of two treatment regimens, R-CMOP and R-CHOP, for patients with low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL). It is a prospective, randomized, controlled, multicenter trial that aims to determine which regimen provides better outcomes for patients. Participants will be monitored for treatment response and safety over the course of the study. The trial includes patients aged 18 to 80 with pathologically confirmed DLBCL and no prior treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with DLBCL, potentially enhancing their survival rates and quality of life.
How similar studies have gone: Other studies have shown promising results with similar treatment regimens, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Aged ≥18,≤80 years, both male and female. 2. Pathologically confirmed DLBCL 3. No prior treatment for DLBCL. 4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0- 6. Expected survival ≥3 months. 7. International Prognostic Index (IPI) ≤ 2 8. Sufficient bone marrow, liver, and kidney function. Key Exclusion Criteria: 1. Other types of LBCL:Primary Cutaneous Diffuse Large B-cell Lymphoma (Leg Type), Primary Mediastinal (Thymic) Large B-cell Lymphoma, Lymphomatoid Granulomatosis, ALK-positive Diffuse Large B-cell Lymphoma, Plasmablastic Lymphoma, Intravascular Large B-cell Lymphoma, T-cell/Histiocyte-rich Large B-cell Lymphoma, and others. 2. Transformed DLBCL. 3. Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention. 4. The patients had previously received antitumor therapy. 5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome. 6. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception. 7. Mentally ill persons or persons unable to obtain informed consent. 8. The investigators think that the patient is not suitable for the study.
Where it's running
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The Fifth Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangdong, China Recruiting -
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China Recruiting -
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China Not yet recruiting -
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China Not yet recruiting -
The Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, China Not yet recruiting -
Shenzhen People's Hospital
Shenzhen, Guangdong, China Not yet recruiting
Show 4 more locations
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Guangxi Zhuang Autonomous Region Cancer Hospital
Guilin, Guangxi, China Not yet recruiting -
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, China Not yet recruiting -
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, China Not yet recruiting -
Beijing Tongren Hospital
Beijing, China Not yet recruiting
Study contacts
- Study coordinator: Qingqing Cai, MD. PhD.
- Email: caiqq@sysucc.org.cn
- Phone: 0086-20-87342823
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL
This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.
-
Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL
This study tests whether glofitamab with chemotherapy (JS203-GemOx) helps patients with relapsed or refractory DLBCL more than rituximab with chemotherapy.
-
Non-Hodgkin Lymphoma Sample Collection for MRD Testing
This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.
-
External beam radiation followed by bispecific antibody therapy for relapsed or refractory DLBCL
This study tests whether giving targeted radiation first, then bispecific antibodies (epcoritamab or glofitamab), is tolerable for adults with relapsed or refractory diffuse large B-cell lymphoma.
-
Chidamide maintenance for MRD-positive double-expressor DLBCL in first remission
This study tests whether giving chidamide as maintenance therapy can help people with double-expressor DLBCL who have complete remission but still have MRD detected in their blood.
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Cognitive changes in people treated for diffuse large B‑cell lymphoma
This study tests whether adults with newly diagnosed diffuse large B‑cell lymphoma experience cognitive changes during and after standard chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.