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A Study of R-mini-MCOP in the Treatment of Elderly, Previously Untreated DLBCL | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

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

NCT06921044•Xiaohui He

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

80 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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;
+1 more criteria

Key Dates

Start Date

April 16, 2025

Primary Completion Date

February 1, 2026

Completion Date

March 1, 2027

Last Updated

April 10, 2025

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone

DRUG

Contacts

Sheng Yang

CONTACT

13683260156 medart@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of R-mini-MCOP in the Treatment of Elderly, Previously Untreated DLBCL

Inclusion Criteria

Exclusion Criteria

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