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

NCT ID: NCT06921044

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-16
• Study Completion Date: 2027-03-01

Brief 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

Conditions

Diffuse Large B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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）

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Xiaohui He

OTHER

Sponsor Role: lead

Responsible Party

Xiaohui He

Chief physician，Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Sheng Yang

Role: CONTACT

medart@126.com

13683260156

Other Identifiers

CSPC-DED-DLBCL-K15

Identifier Type: -

Identifier Source: org_study_id