- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01180049
Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
-
-
New South Wales
-
Kogarah, New South Wales, Австралия, 2217
- St George Hospital
-
-
South Australia
-
Adelaide, South Australia, Австралия, 5000
- Royal Adelaide Hospital
-
-
Tasmania
-
Hobart, Tasmania, Австралия, 7000
- Royal Hobart Hospital
-
-
Victoria
-
Box Hill, Victoria, Австралия, 3128
- Box Hill Hospital
-
Melbourne, Victoria, Австралия, 3004
- The Alfred Hospital
-
-
-
-
-
Aachen, Германия, 52074
- Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV
-
Mainz, Германия, 55131
- Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik
-
-
-
-
-
Catania, Италия, 95124
- Presidio Ferrarotto - A.O.U. - PoliclinicoVittorio Emanuele
-
Modena, Италия, 41124
- Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica
-
Torino, Италия, 10126
- Struttura Complessa di Ematologia, Dipartimento di Oncologia ed Ematologia-
-
-
-
-
-
Seoul, Корея, Республика, 135-710
- Samsung Medical Center
-
Seoul, Корея, Республика, 120-752
- Severance Hospital, Yonsei University
-
-
-
-
-
Krakow, Польша, 30-510
- Malopolskie Centrum Medyczne s.c.
-
-
-
-
-
Kazan, Российская Федерация, 420029
- Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic
-
Saint-Petersburg, Российская Федерация, 197022
- GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
-
Saint-Petersburg, Российская Федерация, 197022
- Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
-
-
-
-
-
Bucuresti, Румыния, 030171
- Spitalul Clinic Coltea, Clinica de Hematologie
-
Bucuresti, Румыния, 022328
- Institutul Clinic Fundeni Bucuresti, Sectia II Hematologie
-
Bucuresti, Румыния, 050098
- Spitalul Universitar de Urgenta Bucuresti, Clinica de Hematologie
-
-
-
-
-
Belgrade, Сербия, 11000
- Clinical Centre of Serbia,Clinic for Hematology
-
Sremska Kamenica, Сербия, 21204
- Oncology Institute of Vojvodina
-
-
-
-
Florida
-
Miami, Florida, Соединенные Штаты, 33133
- Mercy Research Institute
-
-
New Jersey
-
East Orange, New Jersey, Соединенные Штаты, 07018
- Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Соединенные Штаты, 73120
- Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley
-
Oklahoma City, Oklahoma, Соединенные Штаты, 73120
- Mercy Hospital Oklahoma City-Oncology Infusion
-
-
Washington
-
Seattle, Washington, Соединенные Штаты, 98108
- VA Puget Sound Health Care System
-
Seattle, Washington, Соединенные Штаты, 98108
- Amy Shen, RPh
-
-
-
-
-
Vandoeuvre les Nancy, Франция, 54500
- CHU de Nancy
-
-
-
-
-
Praha 10, Чехия, 100 34
- Fakultní Nemocnice Královské Vinohrady
-
Praha 2, Чехия, 128 08
- Vseobecna Fakultni Nemocnice V Praze
-
-
Czech Republic
-
Praha 10, Czech Republic, Чехия, 10034
- Fakultní Nemocnice Královské Vinohrady
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Have confirmed mantle cell lymphoma diagnosis.
- Have measurable disease.
- Have received at least 2 prior treatment, which may include stem cell transplant.
- Have adequate organ and bone marrow function.
- There are other criteria--please discuss with your doctor.
Exclusion Criteria:
- Had any prior treatment with temsirolimus or mTOR inhibitor.
- Had allogeneic stem cell transplant within last 6 months and on immunosuppressive therapy.
- Has active or untreated brain or central nervous system metastases.
- There are other criteria--please discuss with your doctor.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Активный компаратор: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly
|
175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Другие имена:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Другие имена:
|
Активный компаратор: temsirolimus (Torisel) 75mg weekly
|
175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Другие имена:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Independently Assessed Progression-free Survival (PFS)
Временное ограничение: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
|
PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first. PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4. PFS assessment was done using EMA guidelines for sensitivity analysis censoring. Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment. |
From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Overall Survival (OS)
Временное ограничение: From randomization date until death due to any cause (average follow up done for 56.1 months)
|
OS is defined as the time from the date of randomization to the date of death due to any cause.
|
From randomization date until death due to any cause (average follow up done for 56.1 months)
|
Independent Assessment - Objective Response Rate (ORR = CR + PR)
Временное ограничение: From randomization date until end of treatment (average follow up done for 15 months)
|
ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results. Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR. |
From randomization date until end of treatment (average follow up done for 15 months)
|
Investigator's Assessment ORR (ORR = CR + PR)
Временное ограничение: From randomization date until end of treatment (average follow up done for 15 months)
|
ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results. Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR. |
From randomization date until end of treatment (average follow up done for 15 months)
|
Investigator Assessed PFS
Временное ограничение: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
|
PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first. PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4. PFS assessment was done using EMA guidelines for sensitivity analysis censoring. Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment. |
From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
|
Percentage of Participants With Treatment-Emergent Infection- Related Adverse Events (AEs) With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Временное ограничение: From screening up to a maximum of 57.1 months
|
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state.
Treatment-emergent infection-related AEs included events: pneumonia, bronchitis, infection, herpes simplex, oral candidiasis and sepsis.
Grading by NCI CTCAE Version 3.0.: Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening; urgent intervention indicated; Grade 5= death.
|
From screening up to a maximum of 57.1 months
|
Percentage of Participants With Treatment-Emergent Bleeding-Related AEs With Grade 2 or Higher as Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Временное ограничение: From screening up to a maximum of 57.1 months
|
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
Treatment emergent adverse event=as an event that emerged during treatment period that was absent before treatment, or worsened during treatment period relative to pretreatment state.
Treatment-emergent bleeding related AEs included events: epistaxis and ecchymosis.
AE were assessed according to maximum severity grading based on NCI CTCAE Version 4.03.Grade 1=mild; Grade 2=moderate; within normal limits.
Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening or disabling; urgent intervention indicated; Grade 5=death.
|
From screening up to a maximum of 57.1 months
|
Quantify the Potential Effect of TEMSR on AUC and Cmax
Временное ограничение: From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)
|
Potential TEMSR effects were investigated by calculating the ratio of AUCs with and without concomitant TEMSR from the model-estimated effect of TEMSR on apparent clearance (CL/F) values and using individual ratios of observed Cmax values with and without concomitant temsirolimus, for both parent and metabolite. The AUC mean ratio was calculated as 1 / mean shift on apparent clearance from TEMSR, and the 90% CI of the AUC ratios was calculated as 1 / 90% CI of the shift on apparent clearance from TEMSR. AUC: Area under plasma concentration-time curve from time zero to infinity Cmax: Characterization of maximum observed plasma concentration |
From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)
|
Соавторы и исследователи
Спонсор
Публикации и 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
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Новообразования
- Лимфопролиферативные заболевания
- Лимфатические заболевания
- Иммунопролиферативные заболевания
- Лимфома
- Лимфома, неходжкинская
- Лимфома, мантийно-клеточная
- Физиологические эффекты лекарств
- Противоинфекционные агенты
- Противоопухолевые агенты
- Иммунодепрессанты
- Иммунологические факторы
- Антибактериальные агенты
- Антибиотики, Противоопухолевые
- Противогрибковые агенты
- Сиролимус
Другие идентификационные номера исследования
- 3066K1-4438
- B1771007 (Другой идентификатор: Alias Study Number)
- 2009-015498-11 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана 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. .