Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia

Официальное название

Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia: Multicenter, Phase 2, Clinical Trial

Обзор

Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.

Подробное описание

Subjects will be included voluntarily after informed consent. Diagnosis of AML in accordance with the WHO classification and determination of inegibility to induction therapy or refractory or relapsed disease after initial treatment.

Вмешательства

• Препарат Venetoclax
  Venetoclax, PO (tablet), 200 - 400mg, once-daily, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).
• Препарат Cytarabine Injection
  Cytarabine, Subcutaneous injection, 10 - 100mg per square meter, once-daily, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).
• Препарат Metformin
  Metformin, PO (tablet), 850mg, three times a day, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: 12 months and 24 months]

Вторичные конечные точки (2)

• Composite Complete Response Rate (CCR) [Срок оценки: 12 months and 24 months]
• Negative Measurable Residual Disease (MRD) Rate [Срок оценки: 12 months and 24 months]

Критерии участия

Критерии включения

• Diagnosis of AML in accordance with the World Health Organization criteria.
• Ineligibility for induction chemotherapy due to age (≥ 70 years) or, for patients 18 to 74 years of age, ECOG-PS 2 or 3, creatinine clearance below 60 mL/min/1,73m², left ventricular ejection fraction ≤ 50%.
• Projected life expectancy of at least 12 weeks.
• Not requiring supplemental oxygen or substitutive renal therapy.
• Female participants must be either postmenopausal, surgically sterile or practicing at least one protocol specified method of birth control starting at Study Day 1 through at least 180 days after the last dose of study drug.
• Male participants must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol specified methods of contraception and to refrain from sperm donation from initial study drug administration through at least 180 days after the last dose of study drug.
• Participant must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Критерии исключения

• Diagnosis of acute promyelocytic leukemia (APL).
• Known central nervous system (CNS) involvement with AML.
• Known human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, or other active viral, bacterial or fungal infection requiring treatment.
• History of other malignancies prior to study entry, with the exception of non-melanoma skin cancer.
• Chronic Liver Disease and Cirrhosis with a class B or C Child-Pugh score.

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

Бразилия · 5 центров

• Hospital Ophir Loyola — Belém
• Hospital de Clínicas da UFPR — Curitiba
• Hospital Universitario Polydoro Ernani de Sao Thiago — Florianópolis
• Hospital Amaral Carvalho — Jaú
• Hospital Municipal Sao Jose — Joinville

Идентификаторы

NCT: NCT06537843 · VenCM-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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