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

April 8, 2025 updated by: Xiaohui He

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R-mini-MCOP
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）
Drug: R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate （CRR）
Time Frame: At the end of Cycle 2 (each cycle is 21 days)
Complete response rate at the end of induction
At the end of Cycle 2 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response (CR+PR) Rate （ORR）
Time Frame: At the end of Cycle 2 (each cycle is 21 days)
Overall Response (CR+PR) rate at the end of induction
At the end of Cycle 2 (each cycle is 21 days)
Duration of response (DOR)
Time Frame: From the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression or death from other causes will be censored at their last assessment date (24 months from response date)
From the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression or death from other causes will be censored at their last assessment date (24 months from response date)
Progression-free survival (PFS)
Time Frame: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (12,24 months)
Time between the date of enrolment and the date of disease progression, relapse or death from any cause (12,24 months)
Overall Survival (OS)
Time Frame: Time between the date of enrolment and the date of death from any cause (12,24, 36 and 48 months)
Time between the date of enrolment and the date of death from any cause (12,24, 36 and 48 months)
Event Free Survival (EFS)
Time Frame: From the date of enrolment to the date of disease progression, relapse from CR, initiation of subsequent systemic anti-lymphoma therapy after the least 6 cycles of RI-CHOP (each cycle is 21 days), or death whichever occurs first (24, 36 and 48 months)
From the date of enrolment to the date of disease progression, relapse from CR, initiation of subsequent systemic anti-lymphoma therapy after the least 6 cycles of RI-CHOP (each cycle is 21 days), or death whichever occurs first (24, 36 and 48 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiaohui He

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 16, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DED-DLBCL-K15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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