NCT06760039RecruitingPhase 1/2
Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of DLBCL
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
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 30 Dec 2024
- Start date
- 10 Jan 2025
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06760039
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 112
- From 10 Jan 2025 to the primary completion date, 31 Aug 2028
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patients had previously received antitumor therapy.
Other illness
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
Age
- Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
Other
- 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.
- Transformed DLBCL.
- Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention.
- Mentally ill persons or persons unable to obtain informed consent.
- The investigators think that the patient is not suitable for the study.
Who the study is looking for
- Aged ≥18,≤80 years, both male and female.
- Pathologically confirmed DLBCL
- No prior treatment for DLBCL.
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- Expected survival ≥3 months.
- International Prognostic Index (IPI) ≤ 2
- Sufficient bone marrow, liver, and kidney function.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tongren Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Fujian Provincial Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| Ganzhou Cancer Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Not yet recruiting |
| The Affiliated Hospital of Guangdong Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The Fifth Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangxi Zhuang Autonomous Region Cancer Hospital Coordinator of this site? Confirm its status | Guilin | China | Not yet recruiting |
| Gansu Provincial Cancer Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Not yet recruiting |
| Jiangxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| The Fifth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Zhuhai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.