- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02008006
BENdamustine at Elevated Dose for Relapsed Follicular Lymphoma in Intensification Therapy and Transplantation (BENEFIT) (BENEFIT)
A Multicenter Phase II Study Evaluating BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Prior to Autologous Stem Cell Transplant for First and Second Chemosensitive Relapses in Patients With Follicular Lymphoma
Обзор исследования
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Côte d'Or
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Dijon, Côte d'Or, Франция, 21000
- CHU de Dijon - Hopital le Bocage
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Haute Normandie
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Rouen, Haute Normandie, Франция, 76038
- Centre Henri Becquerel
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Hérault
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Montpellier, Hérault, Франция, 34295
- CHRU de Montpellier, Hôpital Saint-Eloi
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Ile De France
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Paris, Ile De France, Франция, 75743
- APHP Hopital Necker
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Ile-de-France
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Paris, Ile-de-France, Франция, 75475
- AP-HP Hopital Saint-Louis
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Ille Et Vilaine
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Rennes, Ille Et Vilaine, Франция, 35033
- CHU de Rennes - Hôpital Pontchaillou
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Isère
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Grenoble, Isère, Франция, 38043
- CHU Grenoble - Hôpital MICHALLON
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Loire Atlantique
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Nantes, Loire Atlantique, Франция, 44093
- CHU de Nantes hotel Dieu
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Meurthe Et Moselle
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Vandoeuvre Lès Nancy, Meurthe Et Moselle, Франция, 54511
- Chu de Nancy
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Nord Pas De Calais
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Lille, Nord Pas De Calais, Франция, 59037
- Chru de Lille Hopital Claude Huriez
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Rhône
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Lyon, Rhône, Франция, 69473
- Centre LEON BERARD
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Pierre Bénite, Rhône, Франция, 69495
- CHU Lyon Sud
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Val De Marne
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Créteil, Val De Marne, Франция, 94010
- CHU Henri Mondor
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
INCLUSION CRITERIA:
- Histologically confirmed follicular lymphoma relapsed (WHO grade 1, 2, 3a)
- Patients aged from 18 to 65 years
- First or second chemosensitive relapses after salvage therapy (rituximab-chemotherapy) based on 2007 Cheson et al. international response criteria (CR and PR) before the decision of BeEAM (HDT) and ASCT (autologous stem cell transplantation) treatment
- Eligible for ASCT
- Autologous graft with a minimum of a number of cluster of differentiation 34 (CD34+) cells 3.0x106/kg.
- Autologous transplantation will be performed in hematopoietic stem cell transplantation authorized centers.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 to 2
- Minimum life expectancy of 3 months
- Cardiovascular baseline corrected QT interval F ( QTcF) ≤ 450 msec (male) or 470 msec (female)
- Medications that may cause corrected QT interval (QTc) interval prolongation should be avoided by patients entering on trial
Normal organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1.5 G/l
- Platelet count ≥ 100 G/l or > 75 G/l if the bone marrow is involved
- Creatine clearance ≥ 50 ml/min
- Serum Glutamate Oxaloacetate Transaminase (SGOT) and Serum Glutamate Pyruvate Transaminase (SGPT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5 x ULN if liver metastasis
- Total bilirubin ≤ 1.5 x ULN
- Cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan (MUGA scan)
- Negative serum pregnancy test for women of childbearing potential*
- Pregnancy tests will include a negative serum pregnancy test (with a sensitivity of at least 25 mill-International Unit (mIU)/ml)
Women of childbearing potential* and men must agree to use adequate contraception prior to study entry, for the duration of study participation and until 6 months after the end of treatment
- Female patients who meet at least one of the following criteria are defined as women of non-childbearing potential:
- ≥ 50 years old and naturally amenorrheic for ≥ 1 year
- Permanent premature ovarian failure confirmed by a specialist gynecologist
- Previous bilateral oophorectomy
- XY genotype, Turner's syndrome or uterine agenesis
- Female patients who do not meet at least of the above criteria are defined as women of childbearing potential
- Ability to understand and willingness to sign a written informed consent document
- Covered by a medical insurance
- Signed informed consent
EXCLUSION CRITERIA:
- Transformed follicular lymphoma
- Prior autologous or allogeneic transplantation
- Presence of a none chemosensitive disease before HDT according to 2007 Cheson et al. international response criteria (stable or progressive disease)
- Contraindication to any drug contained in the chemotherapy regimens
- Bone marrow infiltration > 25% before HDT+ASCT
- Positive HIV, Hepatitis C Virus (HCV) and Hepatitis B (HBs)Ag serologies
- Current bacterial, viral or fungal infection
- Treatment with any investigational drug within 30 days before enrolment
- Major surgery within 30 days before enrolment
- Participation in another clinical trial within 30 days prior to enrolment in the study and during study
- Any serious active disease or co-morbid medical conditions that would interfere with therapy
- Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 5 years
- Known or suspected hypersensitivity to any of the agents or excipients of the regime under evaluation
- Concomitant treatment with chemotherapy or immunotherapy or radiotherapy
- Yellow fever vaccination (attenuated virus vaccine )
- Pregnant or lactating female
- Abnormalities in cardiac function or clinically significant heart disease such as acute myocardial infarction or unstable angina within 6 months prior to the start of study treatment, heart failure New York Heart Association (NYHA) class III or IV, uncontrolled hypertension or a history of antihypertensive treatment poor compliance, uncontrolled arrhythmias with treatment, except extrasystoles or minor conduction disorders
- Known involvement of the central nervous system by lymphoma
- History of chronic liver disease
- History of hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
- Excessive alcohol use
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 |
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Экспериментальный: BeEAM
High Dose Chemotherapy (HDT) containing :
HDT will be followed by an Autologous Stem Cell Transplantation |
High Dose Chemotherapy (HDT) containing :
HDT will be followed by an Autologous Stem Cell Transplantation on D0
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Event Free Survival rate (EFS)
Временное ограничение: Evaluated by the time from inclusion to the time of event appearance with a time of observation of 2 years after inclusion
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EFS will be measured from the date of inclusion to the date of event defined as : death due to any cause, relapse/progression, or changes in therapies.
Patients with no event at the time of analysis will be censored at the date of the last contact
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Evaluated by the time from inclusion to the time of event appearance with a time of observation of 2 years after inclusion
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Safety profile of BeEAM
Временное ограничение: Evaluated all along the 4 years study follow up for each patient
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The safety analyzable population include all patients who received at least one dose of BeEAM regimen
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Evaluated all along the 4 years study follow up for each patient
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Overall Response Rate (ORR) according to Cheson at al. 2007
Временное ограничение: Evaluated at day 100 after graft
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ORR is defined by the rate of patients in Complete Response (CR) and in Partial Response (PR) at time of evaluation. ORR is assessed according to Cheson et al. 2007 criteria |
Evaluated at day 100 after graft
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Overall Response Rate (ORR) according to Cheson et al. 1999
Временное ограничение: Evaluated at day 100 after graft
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ORR is defined by the rate of patients in Complete Response (CR) and in Partial Response (PR) at time of evaluation. ORR assessed according to Cheson et al. 1999 criteria |
Evaluated at day 100 after graft
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Progression Free Survival (PFS)
Временное ограничение: Evaluated by the time from inclusion to the time of progression with a study duration of 5 years maximum
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PFS will be measured from the date of inclusion to the date of event defined as : progression/relapse or death due to any cause. Patients with no event at the time of analysis will be censored at the date of the last contact. PFS will be assessed among all included patients and in the subgroup of complete responders at the beginning of HDT. |
Evaluated by the time from inclusion to the time of progression with a study duration of 5 years maximum
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Overall Survival (OS)
Временное ограничение: Evaluated by the time from inclusion to the time of death with a study duration of 5 years maximum
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OS will be measured from the date of inclusion to the date of death due to any cause and will be censored at the date of last contact for the patients alive at last contact
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Evaluated by the time from inclusion to the time of death with a study duration of 5 years maximum
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Hervé Ghesquières, Dr, Centre Léon Bérard, Lyon
Публикации и полезные ссылки
Общие публикации
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Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
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
Ключевые слова
- Безопасность
- Фолликулярная лимфома
- Выживаемость без прогрессирования
- Общая скорость отклика
- Фаза II
- Бендамустин
- Общая выживаемость
- Трансплантация аутологичных стволовых клеток
- Chemosensitive relapse
- Высокодозная химиотерапия
- BeEAM
- Свободное выживание в событии
- World Health Organization (WHO) 1 grade
- WHO 2 grade
- WHO 3a grade
Дополнительные соответствующие термины MeSH
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Новообразования
- Лимфопролиферативные заболевания
- Лимфатические заболевания
- Иммунопролиферативные заболевания
- Лимфома, неходжкинская
- Лимфома
- Лимфома, фолликулярная
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Противоинфекционные агенты
- Противовирусные агенты
- Ингибиторы ферментов
- Антиметаболиты, Противоопухолевые
- Антиметаболиты
- Противоопухолевые агенты
- Иммунодепрессанты
- Иммунологические факторы
- Противоопухолевые агенты, алкилирующие
- Алкилирующие агенты
- Миелоаблативные агонисты
- Противоопухолевые агенты растительного происхождения
- Ингибиторы топоизомеразы II
- Ингибиторы топоизомеразы
- Этопозид
- Бендамустин гидрохлорид
- Мелфалан
- Цитарабин
Другие идентификационные номера исследования
- BENEFIT
- 2013-000076-16 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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. .
Клинические исследования BeEAM
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University Hospital Inselspital, BerneHanusk Krankenhaus WienЗавершенныйЛимфома, фолликулярная | Лимфома, крупная В-клеточная, диффузная | Лимфома, мантийно-клеточнаяШвейцария, Австрия
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Northside Hospital, Inc.Teva Pharmaceuticals USAЗавершенныйМножественная миеломаСоединенные Штаты
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University Hospital Inselspital, BerneMundipharma Medical CompanyРекрутинг