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Идёт набор NCT07044687

Study to Assess Adverse Events and Change in Disease Activity of Oral Venetoclax in Combination With Subcutaneous (SC) or Intravenous (IV) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Standard Induction Therapy in India

Фаза IV С лечением Acute Myeloid Leukemia

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: Venetoclax, Azacitidine, Azacitidine.
Кому может быть актуально
Состояния в реестре: Acute Myeloid Leukemia. 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
Индия
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 4 Study of Venetoclax in Combination With Azacitidine in Indian Subjects With Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

Обзор

Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo standard induction therapy, the current standard of care. This study will assess the change in disease activity and adverse events in adult participants with acute myeloid leukemia (AML) being treated with of the combination of azacitidine and venetoclax, in India. The combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Around 40 adult participants with a diagnosis of AML will be enrolled in the study at approximately 15 sites in India. Participants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous (SC) or intravenous (IV) injection on Days 1-7 of each cycle. The total study duration is approximately 29 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Вмешательства

  • Препарат Venetoclax
    Oral Tablet
  • Препарат Azacitidine
    Subcutaneous (SC) Injection
  • Препарат Azacitidine
    Intravenous (IV) Injection

Первичные конечные точки

  • Percentage of Participants with Treatment Emergent Adverse Events (TEAE)s [Срок оценки: Up to Approximately 29 Months]
  • Percentage of Participants with Post-Baseline Laboratory Abnormalities [Срок оценки: Up to Approximately 29 Months]
Вторичные конечные точки (4)
  • Composite Complete Remission (CRc) [Срок оценки: Up to Approximately 29 Months]
  • Composite Complete Remission (CRc) by initiation of Cycle 2 [Срок оценки: Up to Approximately 1 Month]
  • Complete Remission [Срок оценки: Up to Approximately 29 Months]
  • Overall Survival (OS) [Срок оценки: Up to Approximately 29 Months]

Критерии участия

Критерии включения

  • Confirmation of acute myeloid leukemia (AML) diagnosis by 2016 World Health Organization (WHO) criteria, previously untreated, and ineligible for treatment with intensive chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of:
  • 0 to 2 for subject ≥ 75 years of age.
  • 0 to 3 for subject ≥ 18 to 74 years of age.

Критерии исключения

  • History of any malignancy within 2 years prior to study entry with exception to those noted in the protocol.
  • Have received any investigational drug 30 days prior to the first dose of study drug and have received strong CYP3A inducers within 7 days prior to the initiation of study treatment.

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

Индия · 11 центров
  • Fortis Memorial Research Institute /ID# 268697 — Gurgaon
  • Mazumdar Shaw Medical Center /ID# 270677 — Bengaluru
  • Regional Cancer Centre /ID# 268785 — Thiruvananthapuram
  • LMMF's Deenanath Mangeshkar Hospital & Research Center /ID# 268781 — Pune
  • Sahyadri Super Speciality Hospital /ID# 272074 — Pune
  • All India Institute Of Medical Sciences - New Delhi /ID# 268357 — New Delhi
  • Rajiv Gandhi Cancer Institute And Research Centre /ID# 268293 — New Delhi
  • All India Institute Of Medical Sciences - Bhubaneswar /ID# 274879 — Bhubaneswar
  • … и ещё 3 центра

Идентификаторы

NCT: NCT07044687 · M23-826

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗