Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of DLBCL

Официальное название

Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of Low-risk and Medium-risk Diffuse Large B-cell Lymphoma (DLBCL): a Randomized, Controlled, Open-label, Multicenter, Phase Ib/II Clinical Study

Обзор

This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL).

Вмешательства

• Препарат R-CMOP Regimen
  Rituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally
• Препарат R-CHOP Regimen
  Rituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally

Первичные конечные точки

• 2-year event-free survival (EFS) rate assessed by the independent review committee [Срок оценки: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment.]
• RP2D(Phase Ib) [Срок оценки: Cycle 1 in R-CMOP group (28 days)]
• DLT(Phase Ib) [Срок оценки: Cycle 1 in R-CMOP group (28 days)]

Вторичные конечные точки (6)

• 2-year event-free survival (EFS) rate assessed by the investigators [Срок оценки: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the investigators' assessment.]
• AE and SAE (Phase Ib) [Срок оценки: Up to 24 weeks]
• 2-year Progression-free survival(PFS) [Срок оценки: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment]
• 2-year Overall survival(OS) [Срок оценки: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment]
• Objective response rate (ORR) [Срок оценки: Up to 24 weeks]
• Complete response rate (CRR) [Срок оценки: Up to 24 weeks]

Критерии участия

Критерии включения

• Aged ≥18,≤80 years, both male and female.
• Pathologically confirmed DLBCL
• No prior treatment for DLBCL.
• There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
• Expected survival ≥3 months.
• International Prognostic Index (IPI) ≤ 2
• Sufficient bone marrow, liver, and kidney function.

Критерии исключения

• Other types of LBCL:Primary Cutaneous Diffuse Large B-cell Lymphoma (Leg Type), Primary Mediastinal (Thymic) Large B-cell Lymphoma, Lymphomatoid Granulomatosis, ALK-positive Diffuse Large B-cell Lymphoma, Plasmablastic Lymphoma, Intravascular Large B-cell Lymphoma, T-cell/Histiocyte-rich Large B-cell Lymphoma, and others.
• Transformed DLBCL.
• Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention.
• The patients had previously received antitumor therapy.
• Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
• Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
• Mentally ill persons or persons unable to obtain informed consent.
• The investigators think that the patient is not suitable for the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 10 центров

• Fujian Provincial Cancer Hospital — Фучжоу
• Gansu Provincial Cancer Hospital — Lanzhou
• The Fifth Affiliated Hospital of Guangzhou Medical University. — Гуанчжоу
• The Affiliated Hospital of Guangdong Medical University — Гуанчжоу
• Shenzhen People's Hospital — Шэньчжэнь
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
• Guangxi Zhuang Autonomous Region Cancer Hospital — Guilin
• Ganzhou Cancer Hospital — Ganzhou
• … и ещё 2 центра

Идентификаторы

NCT: NCT06760039 · B2024-737-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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