Clinical trial · Interventional
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
NCT06760039CI-TRIAL-00088081recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-CHOP Regimen | Drug | R-CHOP Regimen | ALIAS |
| R-CMOP Regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- R-CMOP group
- interventionNames
- Drug: R-CMOP Regimen
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- R-CHOP group
- interventionNames
- Drug: R-CHOP Regimen
Primary outcomes (3)
- measure
- 2-year event-free survival (EFS) rate assessed by the independent review committee
- timeFrame
- Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.