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

17. května 2019 aktualizováno: 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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

101

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly
Lék: 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
Ostatní jména:
  • Torisel
Lék: temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Ostatní jména:
  • Torisel
Aktivní komparátor: temsirolimus (Torisel) 75mg weekly
Lék: 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
Ostatní jména:
  • Torisel
Lék: temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Ostatní jména:
  • Torisel

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Independently Assessed Progression-free Survival (PFS)
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival (OS)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. března 2011

Primární dokončení (Aktuální)

1. listopadu 2015

Dokončení studie (Aktuální)

1. června 2018

Termíny zápisu do studia

První předloženo

9. srpna 2010

První předloženo, které splnilo kritéria kontroly kvality

10. srpna 2010

První zveřejněno (Odhad)

11. srpna 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. května 2019

Naposledy ověřeno

1. května 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 3066K1-4438
  • B1771007 (Jiný identifikátor: Alias Study Number)
  • 2009-015498-11 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ano

Popis plánu 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.

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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