- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02709083
Dasatinib or Nilotinib Followed by Imatinib in Patients With Newly Diagnosed, Chronic Phase Chronic Myeloid Leukemia
First-Line Dasatinib or Nilotinib Followed by Response Guided Switch to Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
PRIMARY OBJECTIVE:
I. To assess incidence of major molecular response (MMR) at 12 months.
SECONDARY OBJECTIVES:
I. To assess progression free survival (PFS) at 12 and 24 months.
II. To assess accelerated phase (AP) or blast phase (BP) transformation-free survival at 12 and 24 months.
III. To assess incidence of deep MRs (≥ MR⁴) at 12 months and 24 months.
IV. To assess safety.
V. To assess patient reported outcomes (PRO).
TERTIARY OBJECTIVES:
I. To assess prognostic significance of detecting aberrant myeloid or lymphoid markers on diagnostic bone marrow.
II. To assess ability to enroll subjects who maintain deep molecular remissions in tyrosine kinase inhibitors (TKIs) discontinuation trials.
OUTLINE:
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist. Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.
After completion of study treatment, patients are followed up at 2 weeks and then up to 60 months.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30322
- Emory University/Winship Cancer Institute
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML) (by World Health Organization [WHO] definition) (hydroxyurea permitted up to 7 days prior to enrollment)
- Clinically significant gastrointestinal disease, digestive dysfunction, or surgery that would compromise absorption of oral administration of medications
- Able to give written informed consent and comply with all study visits and procedures
Exclusion Criteria:
- Chronic myeloid leukemia (CML) in AP or BP
- Unable to receive TKI for insurance reasons (uninsurable)
- Refuse or unable to perform telephone or video conferences with research coordinator
- Subjects who are pregnant, breast feeding or sexually active and unwilling to use effective birth control while on treatment with TKI
- Any medical or psychological condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial, poses any additional risk for the subject, or confounds the assessment of the subject
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Treatment-dasatinib, nilotinib, imatinib
Patients receive dasatinib orally (PO) once a day (QD) or nilotinib PO twice a day (BID) at the discretion of the treating hematologist.
Patients achieving either a 1 log reduction at 3 months or a 2 log reduction at 6 months in their breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) transcript levels may switch to imatinib mesylate PO QD.
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Дается устно
Другие имена:
Дается устно
Другие имена:
Given orally
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
The Proportion of Subjects Who Achieve Major Molecular Response (MMR)
Временное ограничение: At 12 months
|
Response will be measured by a decrease in fusion transcript or protein resulting from the 9;22 chromosomal translocation responsible for formation of the Philadelphia Chromosome (BCR-ABL1) levels on a logarithmic scale.
A 1 log reduction is a drop to below 10%, while a major molecular response (MMR) is defined as a 3 log reduction (0.1%).
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At 12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Accelerated Phase (AP) or Blast Phase (BP) Free Survival
Временное ограничение: The time of CML diagnosis to the time of transformation to AP or BP, assessed up to 24 months
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Survival will be defined as the time from CML diagnosis to the time of transformation to accelerated phase (AP) or blast phase (BP).
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The time of CML diagnosis to the time of transformation to AP or BP, assessed up to 24 months
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Change in Patient Reported Outcomes (PRO) Score Extracted From the MD Anderson Symptom Inventory-Chronic Myelogenous Leukemia (CML)
Временное ограничение: Baseline to up to 12 months
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The patient reported outcomes (PRO) score extracted from the MD Anderson Symptom Inventory (MDASI)-Chronic Myelogenous Leukemia (CML) will be determined and intra and inter subject changes will be compared.
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Baseline to up to 12 months
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Duration of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria
Временное ограничение: Up to 30 days after the end-of-treatment
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Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented.
Exposure to drug over time will also be summarized.
The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications.
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Up to 30 days after the end-of-treatment
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Frequency of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) Criteria
Временное ограничение: Up to 30 days after the end-of-treatment
|
Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented.
Exposure to drug over time will also be summarized.
The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications.
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Up to 30 days after the end-of-treatment
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Progression Free Survival (PFS)
Временное ограничение: The time of CML diagnosis to the time of loss of MMR or loss of hematologic response, assessed up to 24 months
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Progression free survival (PFS) will be defined as the time from CML diagnosis to the time of loss of major molecular response (MMR) or loss of hematologic response.
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The time of CML diagnosis to the time of loss of MMR or loss of hematologic response, assessed up to 24 months
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Severity of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria
Временное ограничение: Up to 30 days after the end-of-treatment
|
Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented.
Exposure to drug over time will also be summarized.
The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications.
|
Up to 30 days after the end-of-treatment
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The Number of Subjects With Breakpoint Cluster Region-abelson Murine Leukemia Viral Oncogene Homolog 1 (BCR-ABL1) Transcript Levels ≤ Deep Molecular Responses (MR⁴)
Временное ограничение: Up to 24 months
|
Descriptive statistics will summarize the changes in breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) testing over time will be presented.
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Up to 24 months
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Новообразования по гистологическому типу
- Новообразования
- Заболевания костного мозга
- Гематологические заболевания
- Миелопролиферативные заболевания
- Лейкемия
- Лейкоз, миелоидный
- Лейкоз, миелогенный, хронический, BCR-ABL положительный
- Лейкемия, миелоидная, хроническая фаза
- Молекулярные механизмы фармакологического действия
- Ингибиторы ферментов
- Противоопухолевые агенты
- Ингибиторы протеинкиназы
- Иматиниб мезилат
- Дазатиниб
Другие идентификационные номера исследования
- IRB00087045
- NCI-2016-00162 (Идентификатор реестра: CTRP (Clinical Trial Reporting Program))
- Winship3143-16 (Другой идентификатор: Emory University/Winship Cancer Institute)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .