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

Xiaohui He

Status and phase: Not yet enrolling; Phase 2

Conditions: Diffuse Large B-Cell Lymphoma

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06921044

CSPC-DED-DLBCL-K15

Details and patient eligibility

About

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

Enrollment: 33 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No 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
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

R-mini-MCOP

Experimental group

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）

Treatment:

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