Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia

Официальное название

A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia

Обзор

This research focuses on a prospective, randomized, controlled trial of "Interferon-alpha as maintenance therapy for favorable-risk acute myeloid leukemia." By fully utilizing prospective, randomized, controlled clinical trial and studying the negative conversion of MRD and the survival of favorable-risk AML patients, it aims to explore the efficacy and safety of Interferon-alpha in the maintenance treatment of favorable-risk AML and identify effective measures to prevent relapse, thereby improving the survival of favorable-risk AML patients. The primary endpoint is the negative conversion of MRD at 6 months. The secondary endpoints include the 2-year cumulative incidence of relapse, 2-year event-free survival (EFS), 2-year overall survival (OS), and safety.

Вмешательства

• Препарат Interferon
  Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.

Первичные конечные точки

• 6-month negative conversion of MRD [Срок оценки: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]

Вторичные конечные точки (4)

• CIR [Срок оценки: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]
• EFS [Срок оценки: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]
• OS [Срок оценки: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]
• Treatment-related Safety Indicators [Срок оценки: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]

Критерии участия

Критерии включения

• Aged 18-70 years old (including 18 and 70 years old) with newly diagnosed favorable-risk AML (2022 ELN risk group classification).
• Achieved CR1 after 1-2 cycles of standard chemotherapy.
• Completed 4-6 cycles of consolidation chemotherapy (including at least 2 cycles of high-dose Cytarabine HDAC regimem).
• At the end of consolidation treatment, bone marrow examination confirmed in CR1, flow cytometry MRD negative, but molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by > 3 log, but still detectable.
• Performance status score of 0-2 (ECOG).
• Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal.
• Kidney function: Creatinine ≤ 1.5 times the upper limit of normal.

Критерии исключения

• Acute promyelocytic leukemia (APL).
• AML with normal karyotype and bZIP intramolecular mutations in CEBPA.
• ≥ CR2 status.
• Patients strongly demanding transplantation, and with indications for transplantation but not eligible for transplantation.
• Uncontrolled active infection.
• Severe organ dysfunction.
• Pregnancy.
• Unwillingness to undergo interferon treatment.
• Previous hyperthyroidism or hypothyroidism.
• Participation in other clinical trials within one month.

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 · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT06802718 · 2023PHD001-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗