BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
A Phase I, Open-Label, Dose-Escalation Trial With BI 836826 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma of B Cell Origin
Обзор исследования
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
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Berlin, Германия, 12200
- Charite - Universitatsmedizin Berlin
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Dresden, Германия, 01307
- Universitätsklinikum Carl Gustav Carus Dresden
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Frankfurt am Main, Германия, 60590
- Universitätsklinikum Frankfurt
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Göttingen, Германия, 37075
- Universitätsmedizin Göttingen, Georg-August-Universität
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Hamburg, Германия, 20099
- Asklepios Klinik St. Georg
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Heidelberg, Германия, 69120
- Universitätsklinikum Heidelberg
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Jena, Германия, 07740
- Universitatsklinikum Jena
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Ulm, Германия, 89081
- Universitätsklinikum Ulm
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Seoul, Корея, Республика, 135-710
- Samsung Medical Center
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Seoul, Корея, Республика, 110-744
- Seoul National University Hospital
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Marseille Cedex 09, Франция, 13273
- INS Paoli-Calmettes
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Pierre Bénite, Франция, 69495
- HOP Lyon Sud
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion criteria:
- Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma therapy
- Patients must have either aggressive NHL and received at least one prior anti-CD20 containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at least two prior therapies
- Measurable disease on computed tomography (CT) scan with involvement of one clearly demarcated lesion =2 cm or two or more clearly demarcated lesions of >1.5 cm at longest diameter (this criterion applies only for the expansion cohort)
- Relapse or progression of disease with an indication for therapy as per investigator's judgement
- Life expectancy of =3 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Exclusion criteria:
- Primary central nervous system (CNS) lymphoma or known CNS involvement
- Prior history of malignancy other than a mature B cell neoplasm according to WHO classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the uterine cervix or breast treated with curative therapy) unless the subject has been free of disease and without treatment for at least 5 years
- Last chemotherapy <4 weeks prior to visit 1
- Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1
- Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10 mg/day prednisolone or equivalent
- High-dose therapy with stem cell support <6 months prior to visit 1
- Radio-immunotherapy <3 months prior to visit 1
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Patients with relapsed or refractory NHL
Adult patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin after at least two prior treatments
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Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in First Cycle in Caucasian Patients
Временное ограничение: From the first administration of trial medication to 7 days after the second administration, upto 36 days
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The primary objective of the dose-escalation part of this study was to determine the MTD of BI 836826 in caucasian patients.
The MTD was to be defined on the basis of DLTs observed during the first 2 weeks of the 1st treatment course.
In case of a delay of the second administration, evaluation of DLT was to be prolonged to 7 days after the second administration..
A DLT was defined as any drug-related non-haematological Adverse event (AE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher, except Infusion-related reaction (IRRs) associated with the administration of BI 836826.
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From the first administration of trial medication to 7 days after the second administration, upto 36 days
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Number of Subjects With Dose Limiting Toxicities (DLT) in First Cycle in Caucasian Patients
Временное ограничение: From the first administration of trial medication to 7 days after the second administration, up to 36 days
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Number of subjects with Dose Limiting Toxicities (DLT) in first Cycle during the MTD evaluation period in caucasian patients with relapsed or refractory Non-Hodgkin lymphoma (NHL).
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From the first administration of trial medication to 7 days after the second administration, up to 36 days
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Tumour Size Reduction
Временное ограничение: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Tumour size reduction (lymph nodes, spleen, & liver nodules) defined as best percentage change from baseline in sum of products of diameter (SPD).
Negative value represents decrease in tumour size, & positive value represents an increase in size.
The tumour size of lymph nodes was to be measured as SPD of 2 perpendicular dimensions for up to 6 indicator lesions identified at baseline CT scan.
Spleen & liver were to be described if considered enlarged at baseline by physical examination or CT scan.
If nodules present in spleen &/or liver, was to be measured in 2 perpendicular dimensions.
Median, 25th & 75th percentiles are calculated from unadjusted Kaplan-Meier curve for each treatment cohort.
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Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Best Overall Response Based on All Assessment
Временное ограничение: Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
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Best overall response was best response at any of CT scans and investigator assesment (incase the recent CT scan was not available). Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
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Screening, Week 1, Week 4, Week 7, Week 8, Week 11, Week 14, Week 15, Week 18 and at End of Treatment (EOT)
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Best Overall Response Based on Imaging Data
Временное ограничение: Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Best overall response based on imaging data. Response was assessed as follow according to the Standardized or Revised Response Criteria for Malignant Lymphoma from 1999.:
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Computed tomography (CT) scan performed at screening, at Week 13, and at Week 25.
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Progression Free Survival (PFS)
Временное ограничение: from first treatment until disease progression or death from any cause, up to 12 months.
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PFS was defined as the time from first treatment with BI 836826 until disease progression or death from any cause. For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. |
from first treatment until disease progression or death from any cause, up to 12 months.
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Failure Free Survival (FFS)
Временное ограничение: from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.
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FFS was defined as the time from first treatment with BI 836826 until objective disease progression, death, or start of next Non-Hodgkin lymphoma (NHL) therapy.For disease progression one of the following criteria was required: • Any new lesion >1.5 centimeter (cm) in any axis • Increase of ≥50% from nadir in sum of product of diameter of any previously involved nodes or single nodes or the size of hepatic or splenic nodules. A lymph node with a diameter of the short axis of <1 cm had to increase by ≥50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis • Increase of ≥50% in the longest diameter of any single previously identified node >1 cm in its short axis. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment cohort. |
from first treatment with BI 836826 until objective disease progression, death, or start of next NHL therapy, up to 12 months.
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Полезные ссылки
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1270.2
- 2010-024456-29 (Номер EudraCT)
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