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

Официальное название

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

Обзор

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

Вмешательства

• Препарат 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

Первичные конечные точки

• Complete response rate （CRR） [Срок оценки: At the end of Cycle 2 (each cycle is 21 days)]

Вторичные конечные точки (5)

• Overall Response (CR+PR) Rate （ORR） [Срок оценки: At the end of Cycle 2 (each cycle is 21 days)]
• Duration of response (DOR) [Срок оценки: 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) [Срок оценки: Time between the date of enrolment and the date of disease progression, relapse or death from any cause (12,24 months)]
• Overall Survival (OS) [Срок оценки: Time between the date of enrolment and the date of death from any cause (12,24, 36 and 48 months)]
• Event Free Survival (EFS) [Срок оценки: 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)]

Критерии участия

Критерии включения

• 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) -

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06921044 · CSPC-DED-DLBCL-K15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗