- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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New South Wales
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Kogarah, New South Wales, Australien, 2217
- St George Hospital
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital
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Tasmania
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Hobart, Tasmania, Australien, 7000
- Royal Hobart Hospital
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Victoria
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Box Hill, Victoria, Australien, 3128
- Box Hill Hospital
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Melbourne, Victoria, Australien, 3004
- The Alfred Hospital
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Aachen, Deutschland, 52074
- Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV
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Mainz, Deutschland, 55131
- Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik
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Vandoeuvre les Nancy, Frankreich, 54500
- CHU de Nancy
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Catania, Italien, 95124
- Presidio Ferrarotto - A.O.U. - PoliclinicoVittorio Emanuele
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Modena, Italien, 41124
- Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica
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Torino, Italien, 10126
- Struttura Complessa di Ematologia, Dipartimento di Oncologia ed Ematologia-
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Seoul, Korea, Republik von, 135-710
- Samsung Medical Center
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Seoul, Korea, Republik von, 120-752
- Severance Hospital, Yonsei University
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Krakow, Polen, 30-510
- Malopolskie Centrum Medyczne s.c.
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Bucuresti, Rumänien, 030171
- Spitalul Clinic Coltea, Clinica de Hematologie
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Bucuresti, Rumänien, 022328
- Institutul Clinic Fundeni Bucuresti, Sectia II Hematologie
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Bucuresti, Rumänien, 050098
- Spitalul Universitar de Urgenta Bucuresti, Clinica de Hematologie
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Kazan, Russische Föderation, 420029
- Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic
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Saint-Petersburg, Russische Föderation, 197022
- GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
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Saint-Petersburg, Russische Föderation, 197022
- Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
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Belgrade, Serbien, 11000
- Clinical Centre of Serbia,Clinic for Hematology
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Sremska Kamenica, Serbien, 21204
- Oncology Institute of Vojvodina
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Praha 10, Tschechien, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Praha 2, Tschechien, 128 08
- Vseobecna fakultni nemocnice v Praze
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Czech Republic
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Praha 10, Czech Republic, Tschechien, 10034
- Fakultni nemocnice Kralovske Vinohrady
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Florida
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Miami, Florida, Vereinigte Staaten, 33133
- Mercy Research Institute
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New Jersey
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East Orange, New Jersey, Vereinigte Staaten, 07018
- Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73120
- Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73120
- Mercy Hospital Oklahoma City-Oncology Infusion
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Washington
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Seattle, Washington, Vereinigte Staaten, 98108
- VA Puget Sound Health Care System
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Seattle, Washington, Vereinigte Staaten, 98108
- Amy Shen, RPh
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver 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
Andere Namen:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Andere Namen:
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Aktiver 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
Andere Namen:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Independently Assessed Progression-free Survival (PFS)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Overall Survival (OS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Lymphoproliferative Erkrankungen
- Lymphatische Erkrankungen
- Immunproliferative Erkrankungen
- Lymphom
- Lymphom, Non-Hodgkin
- Lymphom, Mantelzelle
- Physiologische Wirkungen von Arzneimitteln
- Antiinfektiva
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Antibakterielle Mittel
- Antibiotika, antineoplastische
- Antimykotika
- Sirolimus
Andere Studien-ID-Nummern
- 3066K1-4438
- B1771007 (Andere Kennung: Alias Study Number)
- 2009-015498-11 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Non-Hodgkin-Lymphom
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Stanford UniversityNational Institutes of Health (NIH); AmgenAbgeschlossenLymphom, Non-Hodgkin | Lymphome: Non-Hodgkin | Lymphome: Periphere Non-Hodgkin-T-Zelle | Lymphome: Kutanes Non-Hodgkin-Lymphom | Lymphome: Non-Hodgkin Diffuse Large B-Zell | Lymphome: Non-Hodgkin Follikel / indolente B-Zelle | Lymphome: Non-Hodgkin-Mantelzelle | Lymphome: Non-Hodgkin-Randzone | Lymphome...Vereinigte Staaten
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SWOG Cancer Research NetworkNational Cancer Institute (NCI); Genentech, Inc.RekrutierungDiffuses großzelliges B-Zell-Lymphom | Wiederkehrendes diffuses großzelliges B-Zell-Lymphom | Refraktäres diffuses großzelliges B-Zell-Lymphom | Primäres mediastinales (thymisches) großes B-Zell-Lymphom | Follikuläres Lymphom Grad 3b | Transformierte follikuläre Lymphe zu Diff Large B-Zell-Lymphom und andere BedingungenVereinigte Staaten
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Estrella Biopharma, Inc.Eureka Therapeutics Inc.Noch keine RekrutierungLymphom | Lymphom, Non-Hodgkin | Non-Hodgkin-Lymphom | Non-Hodgkin-Lymphom | Refraktäres B-Zell-Non-Hodgkin-Lymphom | Refraktäres Non-Hodgkin-Lymphom | Hochgradiges B-Zell-Lymphom | ZNS-Lymphom | Lymphome Non-Hodgkin-B-Zelle | Rezidiviertes Non-Hodgkin-Lymphom | Lymphom, Non-Hodgkins | Großes B-Zell-Lymphom | Lymphom, Non-Hodgkin, Erwachsener und andere Bedingungen
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Marker Therapeutics, Inc.RekrutierungNon-Hodgkin-Lymphom | Non-Hodgkin-Lymphom, Erwachsener | Non-Hodgkin-Lymphom, refraktär | Non-Hodgkin-Lymphom, rezidiviertVereinigte Staaten
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City of Hope Medical CenterNational Cancer Institute (NCI)RekrutierungRefraktäres B-Zell-Non-Hodgkin-Lymphom | Rezidivierendes B-Zell-Non-Hodgkin-Lymphom | Hochgradiges B-Zell-Non-Hodgkin-Lymphom | B-Zell-Non-Hodgkin-Lymphom mittleren GradesVereinigte Staaten
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University Hospital TuebingenAbgeschlossen
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Mayo ClinicNoch keine RekrutierungIndolentes B-Zell-Non-Hodgkin-Lymphom | Rezidivierendes indolentes Non-Hodgkin-Lymphom | Refraktäres indolentes Non-Hodgkin-Lymphom | Rezidivierendes indolentes B-Zell-Non-Hodgkin-Lymphom | Refraktäres indolentes B-Zell-Non-Hodgkin-LymphomVereinigte Staaten
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National Cancer Institute (NCI)RekrutierungRefraktäres B-Zell-Non-Hodgkin-Lymphom | Refraktäres T-Zell-Non-Hodgkin-Lymphom | Rezidivierendes B-Zell-Non-Hodgkin-Lymphom | Wiederkehrendes transformiertes Non-Hodgkin-Lymphom | Rezidivierendes Non-Hodgkin-Lymphom | Refraktäres Non-Hodgkin-Lymphom | Wiederkehrendes T-Zell-Non-Hodgkin-Lymphom und andere BedingungenVereinigte Staaten
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Lazaros LekakisGenentech, Inc.RekrutierungRefraktäres Non-Hodgkin-Lymphom | Rezidiviertes Non-Hodgkin-Lymphom | Aggressives Non-Hodgkin-LymphomVereinigte Staaten
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Chongqing Precision Biotech Co., LtdRekrutierungNon-Hodgkin-Lymphom | Refraktäres Non-Hodgkin-Lymphom | Rezidiviertes Non-Hodgkin-LymphomChina
Klinische Studien zur temsirolimus
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Sheba Medical CenterStanley Medical Research InstituteUnbekanntSchizophrenie | Schizoaffektiven StörungIsrael
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St. Joseph's Healthcare HamiltonPfizer; McMaster UniversityAbgeschlossenNierenzellkarzinomKanada
-
AVEO Pharmaceuticals, Inc.Abgeschlossen
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Dana-Farber Cancer InstituteWyeth is now a wholly owned subsidiary of Pfizer; Millennium Pharmaceuticals...AbgeschlossenMultiples MyelomVereinigte Staaten
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Children's Hospital Medical Center, CincinnatiZurückgezogenLymphom, B-Zell | Leukämie, B-ZelleVereinigte Staaten
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Mathias Witzens-HarigCharite University, Berlin, Germany; Ludwig-Maximilians - University of Munich; Johann Wolfgang Goethe University Hospital und andere MitarbeiterUnbekanntDiffuses großzelliges B-Zell-LymphomDeutschland
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New Mexico Cancer Care AllianceWyeth is now a wholly owned subsidiary of PfizerBeendetSarkomVereinigte Staaten
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Wyeth is now a wholly owned subsidiary of PfizerPfizerAbgeschlossenNeoplasien der Brust
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)Abgeschlossen
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M.D. Anderson Cancer CenterAbgeschlossen