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Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

17 maja 2019 zaktualizowane przez: Pfizer

A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA

This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

101

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Czechy
      • Praha 10, Czechy, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha 2, Czechy, 128 08
        • Vseobecna fakultni nemocnice v Praze
    • Czech Republic
      • Praha 10, Czech Republic, Czechy, 10034
        • Fakultni nemocnice Kralovske Vinohrady
  • Federacja Rosyjska
      • Kazan, Federacja Rosyjska, 420029
        • Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic
      • Saint-Petersburg, Federacja Rosyjska, 197022
        • GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
      • Saint-Petersburg, Federacja Rosyjska, 197022
        • Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
  • Francja
      • Vandoeuvre les Nancy, Francja, 54500
        • CHU de Nancy
  • Niemcy
      • Aachen, Niemcy, 52074
        • Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV
      • Mainz, Niemcy, 55131
        • Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik
  • Polska
      • Krakow, Polska, 30-510
        • Malopolskie Centrum Medyczne s.c.
  • Republika Korei
      • Seoul, Republika Korei, 135-710
        • Samsung Medical Center
      • Seoul, Republika Korei, 120-752
        • Severance Hospital, Yonsei University
  • Rumunia
      • Bucuresti, Rumunia, 030171
        • Spitalul Clinic Coltea, Clinica de Hematologie
      • Bucuresti, Rumunia, 022328
        • Institutul Clinic Fundeni Bucuresti, Sectia II Hematologie
      • Bucuresti, Rumunia, 050098
        • Spitalul Universitar de Urgenta Bucuresti, Clinica de Hematologie
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Centre of Serbia,Clinic for Hematology
      • Sremska Kamenica, Serbia, 21204
        • Oncology Institute of Vojvodina
  • Stany Zjednoczone
    • Florida
      • Miami, Florida, Stany Zjednoczone, 33133
        • Mercy Research Institute
    • New Jersey
      • East Orange, New Jersey, Stany Zjednoczone, 07018
        • Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73120
        • Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73120
        • Mercy Hospital Oklahoma City-Oncology Infusion
    • Washington
      • Seattle, Washington, Stany Zjednoczone, 98108
        • VA Puget Sound Health Care System
      • Seattle, Washington, Stany Zjednoczone, 98108
        • Amy Shen, RPh
  • Włochy
      • Catania, Włochy, 95124
        • Presidio Ferrarotto - A.O.U. - PoliclinicoVittorio Emanuele
      • Modena, Włochy, 41124
        • Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica
      • Torino, Włochy, 10126
        • Struttura Complessa di Ematologia, Dipartimento di Oncologia ed Ematologia-

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly
Lek: temsirolimus
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
Inne nazwy:
  • Torisel
Lek: temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Inne nazwy:
  • Torisel
Aktywny komparator: temsirolimus (Torisel) 75mg weekly
Lek: temsirolimus
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
Inne nazwy:
  • Torisel
Lek: temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Inne nazwy:
  • Torisel

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Independently Assessed Progression-free Survival (PFS)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival (OS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 marca 2011

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2015

Ukończenie studiów (Rzeczywisty)

1 czerwca 2018

Daty rejestracji na studia

Pierwszy przesłany

9 sierpnia 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 sierpnia 2010

Pierwszy wysłany (Oszacować)

11 sierpnia 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 maja 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 maja 2019

Ostatnia weryfikacja

1 maja 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 3066K1-4438
  • B1771007 (Inny identyfikator: Alias Study Number)
  • 2009-015498-11 (Numer EudraCT)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu IPD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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