Status:
NOT_YET_RECRUITING
A Study of R-mini-MCOP in the Treatment of Elderly, Previously Untreated DLBCL
Lead Sponsor:
Xiaohui He
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
80+ years
Phase:
PHASE2
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： Sing...
Eligibility Criteria
Inclusion
- Age ≥ 80 years
- The histopathological diagnosis was diffuse large B-cell lymphoma, and immunohistochemistry was positive for CD20
- Previously untreated disease
- Ann Arbor stage I-IV disease
- 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;
- ECOG score 0-4(ECOG score 0-2 after pre-treatment and before R-mini-MCOP regimen)
- 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);
- 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;
- Have the swallowing power
- Life expectancy \> 3 months
- Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF) -
Exclusion
- Previous systemic antitumor therapy (except pre-therapy used before the first cycle of R-CMOP);
- Metastatic diffuse large B-cell lymphoma；
- Known central nervous system lymphoma
- Hypersensitivity to any investigational drug or its ingredients;
- Uncontrollable systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
- 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);
- Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- Other serious comorbidities, intolerance to this protocol or inappropriate participation in this study (judged by the investigator)
- 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);
- Inability to swallow the drug or any significant removal of the small intestine that may prevent full absorption of the drug;
- Situations in which other investigators have determined that participation in this study is not appropriate.
Key Trial Info
Start Date :
April 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06921044
Start Date
April 16 2025
End Date
March 1 2027
Last Update
April 10 2025
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