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Идёт набор NCT05317494

A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Greece

— Наблюдательное 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
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
Греция
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 Prospective Non-Interventional Study to Describe the Effectiveness and Safety of Venetoclax as a First-Line Treatment in Acute Myeloid Leukemia (AML) Patients Who Are Ineligible to Intensive Chemotherapy in Routine Clinical Practice in Greece

Обзор

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for intensive chemotherapy in Greece. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled. Around 100 participants will be enrolled in the study in approximately 15 sites in Greece. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 30 months.

Первичные конечные точки

  • Percentage of Participants Achieving Overall Survival (OS) [Срок оценки: Up to 30 Months]
Вторичные конечные точки (12)
  • Percentage of Participants Achieving Composite Complete Remission [Срок оценки: Up to 30 Months]
  • Total Time of Treatment with Venetoclax Combination Therapy [Срок оценки: Up to 30 Months]
  • Time to Transfusion Independence [Срок оценки: Up to 30 Months]
  • Post Baseline RBC and Platelet Transfusion Independence Rate [Срок оценки: Up to 30 Months]
  • Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important [Срок оценки: Up to 30 Months]
  • Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) [Срок оценки: Up to 30 Months]
  • Healthcare Resource Utilization as the Number of Transfusions (Red Blood Cell [RBC] or Platelets) Received during First-line Treatment in an Outpatient Setting [Срок оценки: Up to 30 Months]
  • Healthcare Resource Utilization as the Number of Hospitalizations during First-line Treatment [Срок оценки: Up to 30 Months]
  • Healthcare Resource Utilization as the Number of Intensive Care Unit (ICU) Admissions during First-line Treatment [Срок оценки: Up to 30 Months]
  • Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner [Срок оценки: Up to 30 Months]
  • Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other) [Срок оценки: Up to 30 Months]
  • Healthcare Resource Utilization as the Dosing Scheme of Relevant Medication due to Infections (Antibiotics or Other) [Срок оценки: Up to 30 Months]

Критерии участия

Критерии включения

  • Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) label.
  • Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.

Критерии исключения

\- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Греция · 13 центров
  • Olympion General Clinic /ID# 268392 — Pátrai
  • General Hospital of Athens Gennimatas /ID# 245968 — Athens
  • General Hospital of Athens Laiko /ID# 244338 — Athens
  • University General Hospital Attikon /ID# 248265 — Athens
  • University General Hospital of Heraklion PA.G.N.I /ID# 244337 — Heraklion
  • General University Hospital of Alexandroupolis /ID# 244235 — Alexandroupoli
  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 24433 — Athens
  • General Anti-cancer Hospital Agios Savvas /ID# 244408 — Athens
  • … и ещё 5 центров

Идентификаторы

NCT: NCT05317494 · P22-535

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗