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Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of DLBCL

RecruitingPhase 1, Phase 2Ages 18 Years - 80 YearsAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. Aged โ‰ฅ18,โ‰ค80 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 โ‰ฅ3 months. 7. International Prognostic Index (IPI) โ‰ค 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.
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What it tests

  • R-CMOP Regimen
  • R-CHOP Regimen
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Where

10 sites
Fujian Provincial Cancer Hospital
Fuzhou, China
Gansu Provincial Cancer Hospital
Lanzhou, China
The Fifth Affiliated Hospital of Guangzhou Medical University.
Guangzhou, China
The Affiliated Hospital of Guangdong Medical University
Guangzhou, China
Shenzhen People's Hospital
Shenzhen, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, China
Guangxi Zhuang Autonomous Region Cancer Hospital
Guilin, China
Ganzhou Cancer Hospital
Ganzhou, China

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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