- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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New South Wales
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Kogarah, New South Wales, Australia, 2217
- St George Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Tasmania
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Hobart, Tasmania, Australia, 7000
- Royal Hobart Hospital
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Victoria
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Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
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Praha 10, Cechia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Praha 2, Cechia, 128 08
- Vseobecna Fakultni Nemocnice V Praze
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Czech Republic
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Praha 10, Czech Republic, Cechia, 10034
- Fakultni nemocnice Kralovske Vinohrady
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Seoul, Corea, Repubblica di, 135-710
- Samsung Medical Center
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Seoul, Corea, Repubblica di, 120-752
- Severance Hospital, Yonsei University
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Kazan, Federazione Russa, 420029
- Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic
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Saint-Petersburg, Federazione Russa, 197022
- GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
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Saint-Petersburg, Federazione Russa, 197022
- Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
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Vandoeuvre les Nancy, Francia, 54500
- CHU de Nancy
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Aachen, Germania, 52074
- Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV
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Mainz, Germania, 55131
- Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik
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Catania, Italia, 95124
- Presidio Ferrarotto - A.O.U. - PoliclinicoVittorio Emanuele
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Modena, Italia, 41124
- Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica
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Torino, Italia, 10126
- Struttura Complessa di Ematologia, Dipartimento di Oncologia ed Ematologia-
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Krakow, Polonia, 30-510
- Malopolskie Centrum Medyczne s.c.
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Bucuresti, Romania, 030171
- Spitalul Clinic Coltea, Clinica de Hematologie
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Bucuresti, Romania, 022328
- Institutul Clinic Fundeni Bucuresti, Sectia II Hematologie
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Bucuresti, Romania, 050098
- Spitalul Universitar de Urgenta Bucuresti, Clinica de Hematologie
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Belgrade, Serbia, 11000
- Clinical Centre of Serbia,Clinic for Hematology
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Sremska Kamenica, Serbia, 21204
- Oncology Institute of Vojvodina
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Florida
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Miami, Florida, Stati Uniti, 33133
- Mercy Research Institute
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New Jersey
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East Orange, New Jersey, Stati Uniti, 07018
- Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73120
- Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley
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Oklahoma City, Oklahoma, Stati Uniti, 73120
- Mercy Hospital Oklahoma City-Oncology Infusion
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Washington
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Seattle, Washington, Stati Uniti, 98108
- VA Puget Sound Health Care System
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Seattle, Washington, Stati Uniti, 98108
- Amy Shen, RPh
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly
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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
Altri nomi:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Altri nomi:
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Comparatore attivo: temsirolimus (Torisel) 75mg weekly
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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
Altri nomi:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Independently Assessed Progression-free Survival (PFS)
Lasso di tempo: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
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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)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Overall Survival (OS)
Lasso di tempo: From randomization date until death due to any cause (average follow up done for 56.1 months)
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OS is defined as the time from the date of randomization to the date of death due to any cause.
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From randomization date until death due to any cause (average follow up done for 56.1 months)
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Independent Assessment - Objective Response Rate (ORR = CR + PR)
Lasso di tempo: From randomization date until end of treatment (average follow up done for 15 months)
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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)
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Investigator's Assessment ORR (ORR = CR + PR)
Lasso di tempo: From randomization date until end of treatment (average follow up done for 15 months)
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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)
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Investigator Assessed PFS
Lasso di tempo: From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)
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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)
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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)
Lasso di tempo: From screening up to a maximum of 57.1 months
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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.
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From screening up to a maximum of 57.1 months
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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)
Lasso di tempo: From screening up to a maximum of 57.1 months
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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.
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From screening up to a maximum of 57.1 months
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Quantify the Potential Effect of TEMSR on AUC and Cmax
Lasso di tempo: From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)
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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)
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma
- Linfoma non Hodgkin
- Linfoma, cellule del mantello
- Effetti fisiologici delle droghe
- Agenti antinfettivi
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti antibatterici
- Antibiotici, Antineoplastici
- Agenti antimicotici
- Sirolimo
Altri numeri di identificazione dello studio
- 3066K1-4438
- B1771007 (Altro identificatore: Alias Study Number)
- 2009-015498-11 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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