A Long-term Extension Study of PCI-32765 (Ibrutinib) (CAN3001)
Last Updated   April 25, 2024 - 21:06
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
sites -
Status
Enrolling by invitation
SUMMARY
This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.
CONDITIONS
- Chronic Graft versus Host Disease
- Chronic Lymphocytic Leukemia
- Diffuse Large B-cell Lymphoma
- Follicular Lymphoma
- Mantle Cell Lymphoma
- Small Lymphocytic Lymphoma
- Waldenstrom Macroglobulinemia
ELIGIBILITY
Inclusion Criteria:
* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
* Agrees to protocol-defined use of effective contraception
* Negative blood or urine pregnancy test at screening
Exclusion Criteria:
* Requires anticoagulation with warfarin or equivalent vitamin K antagonists
* Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study
DETAILS
This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.
LOCATIONS
Country (30) | City or Province (174) | Status |
United States | Ann Arbor, MI University of Michigan Comprehensive Cancer Center |
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United States | Battle Creek, MI Battle Creek Health Systm |
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United States | Boston, MA Dana Farber Cancer Center |
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United States | Charlottesville, VA University of Virginia |
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United States | Chicago, IL Northwestern University Hospital |
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United States | Columbus, OH The Ohio State University- James Cancer Hospital |
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United States | Detroit, MI Karmanos Cancer Institute - Wayne State University |
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United States | Duarte, CA City of Hope Cancer Center |
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United States | Eugene, OR Willamette Valley Cancer Center |
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United States | Goldsboro, NC Southeastern Medical Oncology Center |
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United States | Goshen, IN Indiana University |
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United States | Hackensack, NJ Hackensack University Medical Center |
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United States | Houston, TX MD Anderson Cancer Center - University of Texas |
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United States | La Jolla, CA University of California San Diego Medical Center |
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United States | Lebanon, NH Dartmouth-Hitchcock Medical Center |
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United States | Los Angeles, CA University of California Los Angeles |
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United States | Louisville, KY Louisville Oncology Suburban - Norton Cancer Institute |
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United States | Madison, WI University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research |
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United States | Marietta, GA Northwest Georgia Oncology Centers PC |
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United States | Morgantown, WV West Virginia University |
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United States | New York, NY Memorial Sloan-Kettering Cancer Center |
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United States | New York, NY Weill Medical College of Cornell University |
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United States | Norwalk, CT Norwalk Medical Group |
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United States | Orange, CA St. Joseph Hospital Center for Cancer Prevention and Treatment |
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United States | Philadelphia, PA University of Pennsylvania Medical Center |
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United States | Portland, OR Kaiser Permanente |
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United States | Saint Louis, MO Washington University |
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United States | Seattle, WA University of Washington |
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United States | Sioux Falls, SD Avera Medical Group |
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United States | Stanford, CA Stanford University |
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United States | Stanford, CA Stanford University Medical Center |
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United States | Westwood, KS Kansas University Medical Center |
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United Kingdom | Birmingham, WMD University Hospitals Birmingham NHS Trust, |
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United Kingdom | Bournemouth, DOR Royal Bournemouth Hospital |
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United Kingdom | Colchester, ESS Colchester Hospital University NHS |
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United Kingdom | Glasgow Beatson West Of Scotland Cancer Centre |
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United Kingdom | Leeds, WYK St James's Institute of Oncology |
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United Kingdom | Leicester Leicester Royal Infirmary - Haematology |
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United Kingdom | London King s College Hospital |
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United Kingdom | London St Bartholomew's Hospital - Dept of Haematology |
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United Kingdom | London University College London Hospitals NHSFT |
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United Kingdom | Manchester Christie Hospital |
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United Kingdom | Nottingham Nottingham University Hospitals NHS Trust |
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United Kingdom | Plymouth Derriford Hospital |
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United Kingdom | Sheffield, SYK Royal Hallamshire Hospital |
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United Kingdom | Southampton Southampton General Hospital |
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United Kingdom | Sutton Royal Marsden Hospital (Sutton) |
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Ukraine | Cherkasy Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' |
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Ukraine | Dnepropetrovsk Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center |
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Ukraine | Kharkiv SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine |
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Ukraine | Khmelnitskiy Khmelnitskiy Regional Hospital, Hematology Department |
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Ukraine | Kiev State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine |
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Ukraine | Lviv Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine |
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Ukraine | Vinnitsa Vinnytsya Regional Clinical Hospital named after M.I.Pirogov |
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Turkey | Ankara Ankara University |
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Turkey | Istanbul American Hospital |
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Turkey | Istanbul Istanbul University |
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Turkey | Izmir Dokuz Eylul Universitesi Tip Fakultesi |
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Turkey | Kayseri Erciyes University |
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Taiwan | Changhua County Changhua Cristian Hospital |
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Sweden | Göteborg Sahlgrenska University hospital, Hematology Dept |
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Sweden | Lund Skanes universitetssjukhus |
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Sweden | Stockholm Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm |
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Spain | Barcelona N/a, BA Hospital Vall d'Hebron |
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Spain | L'hospitalet De Llobregat, BA Inst. Cat. Doncologia-H Duran I Reynals |
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Spain | Madrid, MD Fundacion Jimenez Diaz |
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Spain | Madrid, MD Hosp. Gral. Univ. Gregorio Maranon |
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Spain | Madrid, MD Hosp. Univ. Infanta Leonor |
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Spain | Madrid, MD Hosp. Univ. de La Princesa |
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Spain | Pamplona N/a Clinica Universitaria de Navarra |
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Spain | Salamanca, SL Hospital Clinico Universitario Salamanca |
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South Korea | Goyang-Si, 41 National Cancer Center |
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South Korea | Seoul The Catholic University of Korea Seoul St. Mary's Hospital |
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Russia | Arkhangelsk Arkhangelsk Regional Clinical Hospital |
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Russia | Chelyabinsk Chelyabinsk Regiona Onc. Center |
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Russia | Dzerzhinsk Emergency Hospital of Dzerzhinsk |
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Russia | Moscow S.P. Botkin Moscow City Clinical Hospital |
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Russia | Moscow N/a Cancer Research Center |
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Russia | Nizhni Novgorod Regional Clinical Hospital n.a.Semashko |
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Russia | Obninsk Medical Scientific Radiology - Center |
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Russia | Perm Perm Medical Sanitary Unit#1 |
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Russia | Petrozavodsk Republican Hospital named by V.A.Baranova |
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Russia | Rostov-Na-Donu Rostov Research Institute of Oncology |
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Russia | Ryazan Ryazan Regional Clinical Hospital |
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Russia | Saint Leningrad region clinical hospital |
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Russia | Samara Samara Region Clinical Hospital |
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Russia | Sankt-Peterburg Federal Center of Heart, Blood and Endocrinology |
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Russia | Sochi Oncological dispensary #2 |
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Russia | St. Petersburg City Clinical Oncology Dispensary |
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Russia | St.-Petersburg Clinical Research Institute of Hematology and Transfusiology |
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Russia | Syktyvkar Oncology Dispensary of Komi Republic |
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Puerto Rico | San Juan Auxilio Mutuo Cancer Center |
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Portugal | Lisboa Instituto Portugues de Oncologia |
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Portugal | Lisbon Hospital De Santa Maria |
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Portugal | Porto Instituto Portugues de Oncologia |
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Poland | Brzozow Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza |
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Poland | Chorzów Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich |
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Poland | Gdansk Uniwersyteckie Centrum Kliniczne |
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Poland | Krakow Pratia MCM Krakow |
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Poland | Opole Oddzial Hematologii |
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Poland | Slupsk Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka |
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Poland | Wroclaw Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku |
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Netherlands | Amsterdam VU medisch centrum - Afd.Interne - INT |
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Mexico | Oaxaca, OAX Oaxaca Site Management Organization S.C. |
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Japan | Bunkyo-ku, 13 Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital |
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Japan | Hiroshima shi Hiroshima University Hospital |
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Japan | Sapporo-shi, 01 Hokkaido University Hospital |
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Italy | Milano ASST Grande Ospedale Metropolitano Niguarda |
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Italy | Roma DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA'' |
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Italy | Torino A.O.Citta della Salute e della Scienza di Torino |
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Israel | Afula Haemek Medical Center |
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Israel | Hadera Hillel Yaffe Medical Center - Oncology |
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Israel | Haifa, H Rambam Health Care Campus |
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Israel | Petah Tikva Rabin Medical Center Beilinson Campus |
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Israel | Ramat-Gan Sheba Medical Center |
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Israel | Tel Aviv Tel Aviv Sourasky Medical Center |
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Ireland | Dublin St James's Hospital |
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Hungary | Budapest N/a Semmelweis Egyetem, I. Belgyogyaszati Klinika |
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Hungary | Szeged Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika |
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Greece | Athens Laiko General Hospital - 1st department of Internal Medicine |
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Greece | Thessalonikis G Papanikolaou Hospital of Thessaloniki |
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Germany | Berlin, BE Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany |
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Germany | Dresden, SN Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus |
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Germany | Essen Universitätsklinikum Essen; Klinik f. Hämatologie- Germany |
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Germany | Gießen, HE Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie |
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Germany | Heidelberg, BW Universitätsklinikum Heidelberg Med. Klinik IV |
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Germany | Homburg/Saar, SL Universitätsklinikum des Saarlandes |
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Germany | Magdeburg Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany |
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Germany | Marburg, HE OnkoNet Marburg GmbH |
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Germany | Ulm, BW Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany |
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France | Creteil Hopital Henri Mondor |
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France | Mulhouse Hôpital E. Muller |
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France | Paris HOPITAL SAINT LOUIS - Hematology / Oncology |
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France | Paris cedex 15 Hôpital Necker Enfants Malades |
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France | Pessac Hopital Haut Leveque Service Maladie Du Sang |
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France | Pierre Benite CH LYON SUD - Hematology |
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France | Tours CHU de Tours |
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Czechia | Brno Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika |
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Czechia | Praha 10 Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika |
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Czechia | Praha 2 Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie |
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Colombia | Bogota Fundacion Santa Fe |
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Colombia | Floridablanca, SAN Fundacion Oftalmologica de Santander - FOSCAL |
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China | Beijing, 11 Peking University First Hospital |
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China | Beijing, 11 Peking University People s Hospital |
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China | Beijing, 11 Peking University Third Hospital |
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China | Chengdu West China Hospital Sichuan University |
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China | Fuzhou Fujian Medical University |
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China | Guangzhou Sun Yat-sen University Cancer Hospital |
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China | Hangzhou Zhejiang University First Hospital |
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China | Shanghai, 31 Ruijin Hospital |
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China | Shanxi, 14 Tangdu hospital the Fourth Military Medical |
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China | Suzhou, Jaiangsu, 32 The First Affliated Hospital of Soochow University |
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China | Tianjin, 12 The Institute of Hematological disease |
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China | Wuhan Wuhan Union Hospital |
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Canada | Montreal, QC Jewish General Hospital |
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Brazil | Rio De Janeiro, RJ Ministerio da Saude - Instituto Nacional do Cancer |
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Brazil | Salvador, BA Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel |
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Brazil | Sao Paulo, SP Instituto de Ensino e Pesquisa São Lucas |
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Belgium | Antwerp UZA |
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Belgium | Brugge A.Z. Sint Jan |
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Belgium | Brussels, BRU UCL - Saint Luc |
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Belgium | Gent UZ Gent - departement oncologie |
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Belgium | Leuven UZ Leuven Gasthuisberg |
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Belgium | Yvoir, WNA UCL Mont-Godinne |
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Australia | Adelaide, SA Royal Adelaide Hospital |
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Australia | Coburg, VIC John Fawkner Cancer Trial Centre |
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Australia | Concord, NSW Concord Hospital |
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Australia | Heidelberg, VIC Austin Health |
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Australia | Melbourne, VIC Peter MacCallum Cancer Institute |
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Australia | Perth, WA Royal Perth Hospital |
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Australia | Prahran, VIC Alfred Hospital |
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Australia | Wahroonga, NSW Adventist Health Care Limited trading as San Clinical Trials Unit |
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Argentina | Ciudad Autonoma Buenos Aires, B CEMIC Saavedra |
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Argentina | Ciudad de Buenos Aires, B Fundaleu |
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