AZA Combined with R-GemOx for Elderly DLBCL Patients

Официальное название

AZA Combined with R-GemOx for the Initial Treatment of Elderly DLBCL: an Open, Single-arm, Multicenter Clinical Study

Обзор

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of AZA（azacytidine）combined with the R-GemOx (rituximab, gemcitabine and oxaliplatin) regimen as first-line treatment in elderly diffuse large B-cell lymphoma (DLBCL) patients.

Подробное описание

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of AZA in combination with R-GemOx for untreated elderly DLBCL patients.

The induction phase consisted of 8 cycles of AZA in combination with R-GemOx for a total of 8 treatment cycles. The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.

The primary endpoint is the overall response rate (ORR).Secondary efficacy measures included CR and PR,SD, progression-free survival (PFS) and overall survival (OS).

Вмешательства

• Препарат azacytidine
  Azacytidine: 75mg/m2, d1-d5
• Препарат R-GemOx
  Rituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7

Первичные конечные точки

• Objective response rate(ORR) [Срок оценки: Up to 8 cycles (each cycle is 21 days)]

Вторичные конечные точки (5)

• Complete remission(CR) [Срок оценки: Up to 8 cycles (each cycle is 21 days)]
• Partial remission(PR) [Срок оценки: Up to 8 cycles (each cycle is 21 days)]
• Overall Survival (OS) [Срок оценки: From the date of enrollment until the date of death from ant cause, assessed up to 24 months]
• Progression-free survival (PFS) [Срок оценки: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months]
• Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0 [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Критерии включения

• Subjects fully understand and voluntarily participate in this study and sign informed consent.
• Aged ≥60 years, both male and female.
• Pathologically confirmed DLBCL
• There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
• No previous chemotherapy or radiotherapy for DLBCL has been received.
• Expected survival ≥3 months.

Критерии исключения

• DLBCL combined with other types of lymphoma. Transformed DLBCL.
• DLBCL with central nervous system invasion.
• The patients have contraindications to any drug in the combined treatment.
• Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
• 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

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Daping Hospital, Third Military Medical University (Army Medical University) — Чунцин

Идентификаторы

NCT: NCT06778902 · 2024-322 · ZXYZZKY07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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