Идёт набор NCT06372717

A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS

Фаза I С лечением Acute Myeloid Leukemia Refractory Myelodysplastic Syndrome Acute Myeloid Leukemia Myelodysplastic Syndrome With Excess Blasts Acute Myeloid Leukemia, in Relapse

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: APL-4098, Azacitidine and APL-4098, Azacitidine and Venetoclax and APL-4098.
Кому может быть актуально: Состояния в реестре: Acute Myeloid Leukemia Refractory, Myelodysplastic Syndrome Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts, Acute Myeloid Leukemia, in Relapse. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австралия, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome/AML (MDS/AML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)

Обзор

This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB).

Вмешательства

Препарат APL-4098
APL-4098 is administered orally in 28-day cycles
Препарат Azacitidine and APL-4098
Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; APL-4098 is administered orally.
Препарат Azacitidine and Venetoclax and APL-4098
Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; Venetoclax is administered orally; APL-4098 is administered orally.

Первичные конечные точки

Incidence of Treatment Emergent Adverse Events [Safety] [Срок оценки: Through study completion, approximately one year]
Incidence of Dose Limiting Toxicities [Tolerability] [Срок оценки: Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)]
Determine Recommended Phase 2 Dose (RP2D)/Recommended dose range (RDR) levels of APL-4098 alone, in combination with azacitidine, and in combination with azacitidine plus venetoclax. [Срок оценки: Approximately one year]
Assess the Pharmacokinetics of APL-4098 [Срок оценки: On Days 1, 2, 8, and 15 of Cycle 1, and on Day 1 of Cycle 2 (each cycle is 28 days)]
Assess the Pharmacokinetics of APL-4098 [Срок оценки: On Days 1, 2, 8, and 15 of Cycle 1, and on Day 1 of Cycle 2 (each cycle is 28 days)]
Assess the Pharmacokinetics of APL-4098 [Срок оценки: On Days 1, 2, 8, and 15 of Cycle 1, and on Day 1 of Cycle 2 (each cycle is 28 days)]

Вторичные конечные точки (1)

Assess response to disease with APL-4098 alone, in combination with azacitidine, and in combination with azacitidine plus venetoclax. [Срок оценки: Response is assessed at Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 (each cycle is 28 days long), then every three cycles thereafter (assessed for up to 2 years)]

Критерии участия

Критерии включения

18 years or older
Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS)/ AML, or MDS-excess blasts (MDS-EB) with the following characteristics: - R/R AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit.
WBC count ≤ 25,000/microliter
ECOG Performance Status of ≤ 2
Weight ≥ 40kg
Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse
Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study
Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial

Критерии исключения

Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening
Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening
Diagnostic assessments: Left ventricular ejection fraction < 45%, Fridericia's corrected QT interval > 470msec, Aspartate aminotransferase and/or alanine aminotransferase > 3 x upper limit of normal (ULN), total bilirubin > 1.5 x ULN, calculated or measured creatinine clearance < 45 mL/minute (multiply by 0.85 if female)
Infectious disease: HIV positive, active hepatitis B and/or C

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

Здоровые добровольцы: Нет