- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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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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Kazan, Den russiske føderasjonen, 420029
- Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic
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Saint-Petersburg, Den russiske føderasjonen, 197022
- GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
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Saint-Petersburg, Den russiske føderasjonen, 197022
- Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
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Florida
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Miami, Florida, Forente stater, 33133
- Mercy Research Institute
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New Jersey
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East Orange, New Jersey, Forente stater, 07018
- Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73120
- Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley
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Oklahoma City, Oklahoma, Forente stater, 73120
- Mercy Hospital Oklahoma City-Oncology Infusion
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Washington
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Seattle, Washington, Forente stater, 98108
- VA Puget Sound Health Care System
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Seattle, Washington, Forente stater, 98108
- Amy Shen, RPh
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Vandoeuvre les Nancy, Frankrike, 54500
- Chu de Nancy
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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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Seoul, Korea, Republikken, 135-710
- Samsung Medical Center
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Seoul, Korea, Republikken, 120-752
- Severance Hospital, Yonsei University
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Krakow, Polen, 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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Praha 10, Tsjekkia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Praha 2, Tsjekkia, 128 08
- Vseobecna Fakultni Nemocnice V Praze
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Czech Republic
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Praha 10, Czech Republic, Tsjekkia, 10034
- Fakultni nemocnice Kralovske Vinohrady
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Aachen, Tyskland, 52074
- Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV
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Mainz, Tyskland, 55131
- Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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
Andre navn:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Andre navn:
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Aktiv komparator: 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
Andre navn:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Independently Assessed Progression-free Survival (PFS)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom
- Lymfom, Non-Hodgkin
- Lymfom, mantelcelle
- Fysiologiske effekter av legemidler
- Anti-infeksjonsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Sirolimus
Andre studie-ID-numre
- 3066K1-4438
- B1771007 (Annen identifikator: Alias Study Number)
- 2009-015498-11 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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