- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 4. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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New South Wales
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Kogarah, New South Wales, Ausztrália, 2217
- St George Hospital
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South Australia
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Adelaide, South Australia, Ausztrália, 5000
- Royal Adelaide Hospital
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Tasmania
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Hobart, Tasmania, Ausztrália, 7000
- Royal Hobart Hospital
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Victoria
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Box Hill, Victoria, Ausztrália, 3128
- Box Hill Hospital
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Melbourne, Victoria, Ausztrália, 3004
- The Alfred Hospital
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Praha 10, Csehország, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Praha 2, Csehország, 128 08
- Vseobecna fakultni nemocnice v Praze
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Czech Republic
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Praha 10, Czech Republic, Csehország, 10034
- Fakultni nemocnice Kralovske Vinohrady
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Florida
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Miami, Florida, Egyesült Államok, 33133
- Mercy Research Institute
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New Jersey
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East Orange, New Jersey, Egyesült Államok, 07018
- Veterans Affairs New Jersey Healthcare System-Hematology/Oncology Section (111)
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Oklahoma
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Oklahoma City, Oklahoma, Egyesült Államok, 73120
- Mercy Clinic Oklahoma Communities dba Mercy Clinic Oncology/Hematology-McAuley
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Oklahoma City, Oklahoma, Egyesült Államok, 73120
- Mercy Hospital Oklahoma City-Oncology Infusion
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Washington
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Seattle, Washington, Egyesült Államok, 98108
- VA Puget Sound Health Care System
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Seattle, Washington, Egyesült Államok, 98108
- Amy Shen, RPh
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Vandoeuvre les Nancy, Franciaország, 54500
- Chu de Nancy
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Seoul, Koreai Köztársaság, 135-710
- Samsung Medical Center
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Seoul, Koreai Köztársaság, 120-752
- Severance Hospital, Yonsei University
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Krakow, Lengyelország, 30-510
- Malopolskie Centrum Medyczne s.c.
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Aachen, Németország, 52074
- Klinik fuer Onkologie und Haematologie, Medizinische Klinik IV
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Mainz, Németország, 55131
- Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik
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Catania, Olaszország, 95124
- Presidio Ferrarotto - A.O.U. - PoliclinicoVittorio Emanuele
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Modena, Olaszország, 41124
- Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica
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Torino, Olaszország, 10126
- Struttura Complessa di Ematologia, Dipartimento di Oncologia ed Ematologia-
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Kazan, Orosz Föderáció, 420029
- Republican Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republic
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Saint-Petersburg, Orosz Föderáció, 197022
- GBOU VPO "First Saint-Petersburg State Medical University n.a. I.P.Pavlov"
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Saint-Petersburg, Orosz Föderáció, 197022
- Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
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Bucuresti, Románia, 030171
- Spitalul Clinic Coltea, Clinica de Hematologie
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Bucuresti, Románia, 022328
- Institutul Clinic Fundeni Bucuresti, Sectia II Hematologie
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Bucuresti, Románia, 050098
- Spitalul Universitar de Urgenta Bucuresti, Clinica de Hematologie
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Belgrade, Szerbia, 11000
- Clinical Centre of Serbia,Clinic for Hematology
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Sremska Kamenica, Szerbia, 21204
- Oncology Institute of Vojvodina
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Aktív összehasonlító: 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
Más nevek:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Más nevek:
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Aktív összehasonlító: 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
Más nevek:
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Independently Assessed Progression-free Survival (PFS)
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Overall Survival (OS)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Publikációk és hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Immunrendszeri betegségek
- Neoplazmák szövettani típus szerint
- Neoplazmák
- Limfoproliferatív rendellenességek
- Nyirokrendszeri betegségek
- Immunproliferatív rendellenességek
- Limfóma
- Limfóma, non-Hodgkin
- Limfóma, köpenysejt
- A gyógyszerek élettani hatásai
- Fertőzésgátló szerek
- Antineoplasztikus szerek
- Immunszuppresszív szerek
- Immunológiai tényezők
- Antibakteriális szerek
- Antibiotikumok, daganatellenes szerek
- Gombaellenes szerek
- Sirolimus
Egyéb vizsgálati azonosító számok
- 3066K1-4438
- B1771007 (Egyéb azonosító: Alias Study Number)
- 2009-015498-11 (EudraCT szám)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Non-Hodgkin limfóma
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Marker Therapeutics, Inc.ToborzásNon Hodgkin limfóma | Non-Hodgkin limfóma, felnőtt | Non-Hodgkin limfóma, tűzálló | Non-Hodgkin limfóma, kiújultEgyesült Államok
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Chongqing Precision Biotech Co., LtdToborzásNon Hodgkin limfóma | Tűzálló non-Hodgkin limfóma | Kiújult non-Hodgkin limfómaKína
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Caribou Biosciences, Inc.ToborzásLimfóma | Limfóma, non-Hodgkin | B-sejtes limfóma | Non Hodgkin limfóma | Tűzálló B-sejtes non-Hodgkin limfóma | Kiújult non-Hodgkin limfóma | B-sejtes non-Hodgkin limfómaEgyesült Államok, Ausztrália, Izrael
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Estrella Biopharma, Inc.Eureka Therapeutics Inc.Még nincs toborzásLimfóma | Limfóma, non-Hodgkin | Non-Hodgkin limfóma | Non-Hodgkin limfóma | Tűzálló B-sejtes non-Hodgkin limfóma | Tűzálló non-Hodgkin limfóma | Kiváló minőségű B-sejtes limfóma | Központi idegrendszeri limfóma | Limfómák Non-Hodgkin B-sejt | Kiújult non-Hodgkin limfóma | Limfóma, non-Hodgkins | Nagy B-sejtes... és egyéb feltételek
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City of Hope Medical CenterNational Cancer Institute (NCI)ToborzásTűzálló B-sejtes non-Hodgkin limfóma | Ismétlődő B-sejtes non-Hodgkin limfóma | Magas fokú B-sejtes non-Hodgkin limfóma | Közepes fokozatú B-sejtes non-Hodgkin limfómaEgyesült Államok
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National Cancer Institute (NCI)ToborzásTűzálló B-sejtes non-Hodgkin limfóma | Tűzálló T-sejtes non-Hodgkin limfóma | Ismétlődő B-sejtes non-Hodgkin limfóma | Ismétlődő átalakult non-Hodgkin limfóma | Ismétlődő non-Hodgkin limfóma | Tűzálló non-Hodgkin limfóma | Ismétlődő T-sejtes non-Hodgkin limfóma | Ismétlődő elsődleges bőr T-sejtes... és egyéb feltételekEgyesült Államok
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Mayo ClinicMég nincs toborzásIndolens B-sejtes non-Hodgkin limfóma | Ismétlődő indolens non-Hodgkin limfóma | Refrakter indolens non-Hodgkin limfóma | Ismétlődő indolens B-sejtes non-Hodgkin limfóma | Refrakter indolens B-sejtes non-Hodgkin limfómaEgyesült Államok
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The First Affiliated Hospital of Soochow UniversityShanghai Unicar-Therapy Bio-medicine Technology Co.,LtdToborzásTűzálló non-Hodgkin limfóma | Kiújult non-Hodgkin limfómaKína
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Joseph TuscanoSpectrum Pharmaceuticals, IncAktív, nem toborzóKiújult non-Hodgkin limfóma | Refrakter Non Hodgkin limfómaEgyesült Államok
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GC Cell CorporationIsmeretlenTűzálló non-Hodgkin limfóma | Kiújult non-Hodgkin limfómaKoreai Köztársaság
Klinikai vizsgálatok a temsirolimus
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Memorial Sloan Kettering Cancer CenterPfizer; National Comprehensive Cancer NetworkBefejezvePajzsmirigy rákEgyesült Államok
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Wyeth is now a wholly owned subsidiary of PfizerPfizerBefejezveMellrák neoplazmák
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New Mexico Cancer Care AllianceWyeth is now a wholly owned subsidiary of PfizerMegszűntSzarkómaEgyesült Államok
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Mathias Witzens-HarigCharite University, Berlin, Germany; Ludwig-Maximilians - University of Munich; Johann... és más munkatársakIsmeretlenDiffúz nagy B-sejtes limfómaNémetország