ABC Maintenance Therapy for AML

Официальное название

Efficacy and Safety of Maintenance Treatment With Chidamide, Venetoclax, and Azacitidine for Treatment-Naive Acute Myeloid Leukemia Patients Achieving Complete Remission: A Multicenter Study

Обзор

Study Objectives: To evaluate the Relapse-Free Survival (RFS) and 1-year RFS rate in patients with Acute Myeloid Leukemia (AML) receiving maintenance therapy with Chidamide combined with Venetoclax and Azacitidine. Study Design: Prospective, Multicenter, Interventional Cohort Study. Total Enrollment: 104 subjects. Cohort 1 (MRD-Negative Patients): 61 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles. Cohort 2 (MRD-Persistent Positive Patients): 43 subjects Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.

Вмешательства

• Препарат Cohort 1 (MRD-Negative Patients): 61 subjects
  Chidamide (C): 5 mg, orally, once daily, Days 1-14. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.
• Препарат Cohort 2 (MRD-Persistent Positive Patients): 43 subjects
  Chidamide (C): 5 mg, orally, once daily, Days 1-28. Azacitidine (A): 50 mg/m², subcutaneous injection, Days 1-5. Venetoclax (B): 400 mg, orally, once daily (QD), Days 1-14. Cycle: 28 days per cycle, for a total of 12 cycles.

Первичные конечные точки

• Relapse-Free Survival (RFS) [Срок оценки: 1-year RFS rate]

Вторичные конечные точки (5)

• Overall Survival (OS) [Срок оценки: 2-year]
• Event-Free Survival (EFS) [Срок оценки: 2-year]
• Duration of Remission (CRd) [Срок оценки: 2-year]
• Safety Evaluation [Срок оценки: 2-year]
• Analysis of MRD Dynamics and Prognostic Impact [Срок оценки: 2-year]

Критерии участия

Критерии включения

• Patients aged 18 to 80 years with newly diagnosed Acute Myeloid Leukemia (AML)
• Patients who have achieved their first Complete Remission (CR) or Complete Remission with incomplete hematologic recovery (CRi) at the time of enrollment, following induction therapy with intensive chemotherapy and at least 2 cycles of consolidation therapy. Remission must have been achieved within 4 months (±7 days) prior to enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
• Women of childbearing potential are eligible if they meet the following conditions:

• A negative serum or urine pregnancy test is performed within 10-14 days prior to enrollment, and a second negative pregnancy test is performed within 24 hours prior to the initiation of treatment. Both negative results are required to meet the criteria for treatment initiation.
• They agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug.
• Male patients with female partners of childbearing potential are eligible if they agree to practice abstinence or use two effective methods of contraception during the treatment period and for 28 days after discontinuation of the study drug.
• Women of childbearing potential must comply with scheduled pregnancy tests.
• Ability to understand and sign the Informed Consent Form (ICF).

Критерии исключения

• Diagnosis of Acute Promyelocytic Leukemia (APL) or FAB subtype M3 AML.
• Patients with a history of extramedullary leukemia, unless central nervous system (CNS) involvement is controlled.
• Laboratory values that do not meet the following criteria: Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); Serum Creatinine ≤ 2.5 × ULN; Absolute Neutrophil Count (ANC) > 0.5 × 10⁹/L; Platelet Count ≥ 30 × 10⁹/L.
• Uncontrolled comorbidities, including but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina, arrhythmia, or psychiatric illness/social situations that would compromise compliance with the protocol.
• History of AML that was refractory to or did not achieve remission with prior treatment containing Venetoclax, Chidamide, or Azacitidine.
• History of hypersensitivity to any component of the study protocol.
• Pregnant women.
• Patients with active Central Nervous System (CNS) disease.
• Patients with Relapsed or Refractory (R/R) AML.
• Patients who have undergone Hematopoietic Stem Cell Transplantation (HSCT).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog — Ухань

Идентификаторы

NCT: NCT07521124 · Chi-Ven(Bcl-2)-Aza

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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