Clinical trial · Interventional
A Study of R-mini-MCOP in the Treatment of Elderly, Previously Untreated DLBCL
A Multicenter, Prospective Phase Ⅱ Clinical Study of R-mini-MCOP(Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone) in the Treatment of Elderly, Previously Untreated Diffuse Large B-cell Lymphoma
NCT06921044CI-TRIAL-00088387not yet recruitingPhase 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)
Research purpose: To evaluate the efficacy and safety of R-mini-MCOP in first-line treatment of primary treatment of diffuse large B-cell lymphoma (DLBCL) in elderly patients Experimental design: Single-arm, multicenter, prospective study
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-mini-MCOP
- description
- Rituximab :375 mg/m2,ivgtt,d0; Mitoxantrone Liposome : The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2,ivgtt,d1; Vincristine :1mg,ivgtt,d1; Prednisone:40 mg/m2,po.,d1-5; Q3W(Every 3 Weeks)
- interventionNames
- Drug: R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone
Primary outcomes (1)
- measure
- Complete response rate (CRR)
- timeFrame
- At the end of Cycle 2 (each cycle is 21 days)
- description
- Complete response rate at the end of induction
Secondary outcomes (5)
- measure
- Overall Response (CR+PR) Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 80 years 2. The histopathological diagnosis was diffuse large B-cell lymphoma, and immunohistochemistry was positive for CD20 3. Previously untreated disease 4. Ann Arbor stage I-IV disease 5. According to Lugano2014 criteria, there must be at least one matching evaluable or measurable lesion: lymph node lesion, the length of the measurable lymph node must be greater than 1.5cm; For non-lymph node lesions, the measured extra-nodal lesions should be \> 1.0cm in length; 6. ECOG score 0-4(ECOG score 0-2 after pre-treatment and before R-mini-MCOP regimen) 7. Bone marrow function: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80g/L (neutrophil count ≥1.0×109/L, platelet count ≥50×109/L, hemoglobin ≥75 g/L in patients with bone marrow involvement); 8. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion; 9. Have the swallowing power 10. Life expectancy \> 3 months 11. Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF) - Exclusion Criteria: 1. Previous systemic antitumor therapy (except pre-therapy used before the first cycle of R-CMOP); 2. Metastatic diffuse large B-cell lymphoma; 3. Known central nervous system lymphoma 4. Hypersensitivity to any investigational drug or its ingredients; 5. Uncontrollable systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.); 6. Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x103 copies /mL; More than 1x103 copies /mL of HCV RNA); 7. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 8. Other serious comorbidities, intolerance to this protocol or inappropriate participation in this study (judged by the investigator) 9. Previous or current co-occurrence of other malignancies (other than non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years); 10. Inability to swallow the drug or any significant removal of the small intestine that may prevent full absorption of the drug; 11. Situations in which other investigators have determined that participation in this study is not appropriate.
References
Publications (0)
Data not yet available
No reference posted for this study.