Comparing R-CMOP and R-CHOP for treating diffuse large B-cell lymphoma
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
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 |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 10 sites (Fuzhou, Fujian and 9 other locations) |
| Trial ID | NCT06760039 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promising results with similar treatment regimens, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Fuzhou, Fujian and 9 other locations
- Fujian Provincial Cancer Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
- Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
- The Fifth Affiliated Hospital of Guangzhou Medical University. — Guangzhou, Guangdong, China (Recruiting)
- The Affiliated Hospital of Guangdong Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Shenzhen People's Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.