Clinical trial NCT01905943: A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
Official title: A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-23
Enrollment: 979
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.


Eligibility criteria: Inclusion Criteria:

* Previously untreated documented CLL according to National Cancer Institute/international workshop on CLL (NCI/iwCLL) criteria OR relapsed and/or refractory documented CLL participants requiring treatment according to NCI/iwCLL criteria; participants with up to 3 relapses are eligible
* Refractory participants if last treatment was with single-agent therapy, single-agent chemotherapy, or single-agent antibody
* Participants with 17p-deletion and/or p53 mutation may be included at the investigator's discretion
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy greater than (\>) 6 months according to the investigator's opinion
* Adequate hematological function

Exclusion Criteria:

* Participants who have received more than 3 previous CLL treatment lines
* Documented transformation of CLL to aggressive lymphoma (Richter's transformation)
* Participants who are refractory to immunochemotherapy
* Participants with abnormal laboratory values
* One or more individual organ/system impairment score of 4 as assessed by the cumulative illness rating scale (CIRS) definition, excluding the eyes, ears, nose, throat and larynx organ systems
* Participants with a history of progressive multifocal leukoencephalopathy (PML)
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Known hypersensitivity to the study drugs
* History of prior malignancy unless the malignancy has been treated with a curative intent and in remission without treatment for greater than or equal to (\>/=) 5 years prior to enrollment and with the exception of curatively-treated basal cell carcinoma, squamous cell carcinoma of the skin, low grade in situ carcinoma of the cervix, or low grade, early stage localized prostate cancer treated surgically with curative intent
* Regular treatment with corticosteroids during the 28 days prior to the start of Cycle 1, Day 1, unless administered for indications other than CLL at a dose equivalent to less than or equal to (\</=) 30 milligrams per day (mg/day) prednisone
* Regular treatment with immunosuppressive medications following previous organ transplantation
* Evidence of significant, uncontrolled concomitant diseases
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of the nail beds) or a major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization within 28 days prior to the start of Cycle 1, Day 1
* Vaccination with live vaccines within 28 days prior to start of Cycle 1, Day 1
* Major surgery (within 28 days prior to the start of Cycle 1, Day 1), other than for diagnosis
* Positive for chronic hepatitis B, hepatitis C, human T-lymphotropic virus 1 (HTLV 1) or human immunodeficiency virus (HIV) infection
* Pregnant or lactating women
* Fertile men or women of childbearing potential
* Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1, Day 1 and during the study

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to time of primary completion (3 years)
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to time of primary completion (3 years)
measure: Number of Participants With Adverse Events of Particular Interest (AEPIs)
timeFrame: Baseline up to time of primary completion (3 years)
Secondary outcomes:
measure: Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA)
timeFrame: 3 months after the last dose of study treatment (up to approximately 5 years)
measure: Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry
timeFrame: 3 months after the last dose of study treatment (up to approximately 5 years)
measure: Percentage of Participants With Best Overall Response (BOR)
timeFrame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)
measure: Median Time to Progression-Free Survival (PFS)
timeFrame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)
measure: Median Time to Response (TTR)
timeFrame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)
measure: Median Time to Event-Free Survival (EFS)
timeFrame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)
measure: Median Time to Overall Survival (OS)
timeFrame: Baseline until death (Approximately up to 5 years)
measure: Median Time to New Anti-Leukemia Therapy (TTNT)
timeFrame: Baseline until end of study (up to approximately 5 years)
measure: Median Time to Duration of Response (DoR)
timeFrame: Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)
Other outcomes:
Locations:
city: Santa Fé
country: Argentina
facility: Hospital Iturraspe
city: Bruxelles
country: Belgium
facility: Hospital Erasme; Neurologie
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Center Sarajevo, Clinic for Hematology
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: SP
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes; Centro de Oncologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Estadual do Servidor Publico; Hematologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP; Hematologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Santa Marcelina;Oncologia
state: SP
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Moncton
country: Canada
facility: Regional health authority A vitalite health network
state: New Brunswick
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Oncology
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
state: Ontario
city: Greenfield Park
country: Canada
facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve- Rosemont; Oncology
state: Quebec
city: Rimouski
country: Canada
facility: Centre de sante et de services sociaux Rimouski Neigette
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus
state: Saskatchewan
city: Quebec
country: Canada
facility: CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie
city: Cairo
country: Egypt
facility: Cairo University Hospital Al Kasr El Ainy
city: Cairo
country: Egypt
facility: National Cancer Institute
city: Tallinn
country: Estonia
facility: North Estonia Regional Hospital; Hematology
city: Tartu
country: Estonia
facility: Tartu Uni Hospital; Hematology - Oncology Clinic
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital; Hematology
city: Turku
country: Finland
facility: Turku Uni Central Hospital; Dept of Internal Medicine
city: Angers
country: France
facility: Hotel Dieu; Medecine D
city: Argenteuil
country: France
facility: Ch Victor Dupouy; Hematologie
city: Brest
country: France
facility: Hopital Augustin Morvan; Hematologie
city: Caen
country: France
facility: Hopital Cote De Nacre; Hematologie Biologique
city: Clermont Ferrand
country: France
facility: Chu Estaing; Hematologie Clinique Adultes
city: Creteil
country: France
facility: Hopital Henri Mondor; Hematologie Clinique
city: Dijon
country: France
facility: Chu Site Du Bocage;Hematologie Clinique
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental Les Oudairies
city: Le Mans
country: France
facility: Ch Du Mans; Medecine Hematologie Oncologie
city: Lille
country: France
facility: Hopital Claude Huriez; Hematologie
city: Limoges
country: France
facility: Hopital Uni Ire Dupuytren; Hematologie
city: Montpellier
country: France
facility: Hopital Saint Eloi; Hematologie Oncologie Medicale
city: Mulhouse
country: France
facility: Hopital Emile Muller; Hematologie
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme;Hopital De Jour
city: Paris
country: France
facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
city: Paris
country: France
facility: Hopital Saint Antoine; Hematologie Clinique
city: Paris
country: France
facility: Hopital Pitie Salpetriere; Hematologie Clinique
city: Perpignan
country: France
facility: Hopital Saint Jean; Hematologie
city: Pessac
country: France
facility: Hopital De Haut Leveque; Hematologie Clinique
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Hemato Secteur Jules Courmont
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos; Hematologie
city: Reims
country: France
facility: Hopital Robert Debre; Hematologie Clinique
city: Rouen
country: France
facility: Centre Henri Becquerel; Hematologie
city: St Brieuc
country: France
facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll
city: Tours
country: France
facility: Hopital Bretonneau; Hematologie Therapie Cellulaire
city: Augsburg
country: Germany
facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
city: Frankfurt an der Oder
country: Germany
facility: Gemeinschaftspraxis; Prof. Dr. Michael Kiehl und Dr.med. Wolfgang Stein
city: Frankfurt
country: Germany
facility: Onkologisches Zentrum am Bethanien-Kankenhaus
city: Göttingen
country: Germany
facility: Dres.Andreas Ammon und Dirk Meyer
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH
city: Lübeck
country: Germany
facility: Onkologische Schwerpunktpraxis Lübeck
city: Magdeburg
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Mutlangen
country: Germany
facility: Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
city: München
country: Germany
facility: Dres. Hans-Dieter Schick Dorothea Schick Burkhard Schmidt u.w.
city: Neunkirchen/Saar
country: Germany
facility: Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura
city: Pößneck
country: Germany
facility: eps - early phase GmbH
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
city: Regensburg
country: Germany
facility: Schwerpunktpraxis & Tagesklinik f. Hämatologie & Onkologie Regensdorf / Schwandorf / Wörth
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
city: Würzburg
country: Germany
facility: Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos; Hematology
city: Athens
country: Greece
facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
city: Athens
country: Greece
facility: Laiko General Hospital; Hematology Clinic
city: Ioannina
country: Greece
facility: University Hospital of Ioannina; Hematology
city: Thessaloniki
country: Greece
facility: Georgios Papanikolaou Hospital; Hematology Department
city: Dublin
country: Ireland
facility: Mater Misericordiae Uni Hospital; Oncology
city: Limerick
country: Ireland
facility: University Hospital Limerick - Oncology
city: Waterford
country: Ireland
facility: Waterford Regional Hospital; Department Of Medical Oncology
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; Hematology Deptartment
city: Haifa
country: Israel
facility: Bnei-Zion Medical Center; Hematology Dept
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital; Haematology
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Ichilov Sourasky Medical Center; Heamatology
city: Catanzaro
country: Italy
facility: Az. Osp. Pugliese; Divisione de Ematologia
state: Calabria
city: Napoli
country: Italy
facility: Ospedale Cardarelli; Divisione Di Ematologia
state: Campania
city: Ferrara
country: Italy
facility: Arcispedale S. Anna; Sezione Di Ematologia
state: Emilia-Romagna
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Ematologia
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: AUSL di Piacenza - Ospedale "Guglielmo da Saliceto";U.O. Ematologia
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
state: Lazio
city: Genova
country: Italy
facility: Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
state: Liguria
city: Milano
country: Italy
facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
state: Lombardia
city: Milano
country: Italy
facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia
state: Lombardia
city: Novara
country: Italy
facility: Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
state: Piemonte
city: Torino
country: Italy
facility: Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I
state: Piemonte
city: Foggia
country: Italy
facility: Azienda ospedaliera oo rr di foggi; Hematology
state: Puglia
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi; Div. Oncoematologia
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
state: Sardegna
city: Livorno
country: Italy
facility: Azienda USL 6 Livorno - P.O. Livorno; U.O. Ematologia Clinica
state: Toscana
city: Busan
country: Korea, Republic of
facility: Pusan University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre; Division of Hematology/Oncology
city: Riga
country: Latvia
facility: RECUH, Oncology Centre of Latvia; Clinic of Chemotherapy and Heamatology
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
city: Culiacan
country: Mexico
facility: Hospital General De Culiacan; Servicio De Hematologia
city: Mexico City
country: Mexico
facility: Hospital General de México; Haematology
city: Mexico City
country: Mexico
facility: Centro Medico Nacional Sxxi - Imss; Haematology
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology
city: Queretaro
country: Mexico
facility: Centro de Estudios Clinicos de Queretaro (CECLIQ)
city: Skopje
country: North Macedonia
facility: University Clinic of Hematology Skopje, Hospital Care Department
city: Lublin
country: Poland
facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
city: Olsztyn
country: Poland
facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
city: Opole
country: Poland
facility: Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Onco-Hematologia
city: Brasov
country: Romania
facility: Policlinica de Diagnostic Rapid
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Brasov; Clinica de Hematologie
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea; Clinica de Hematologie
city: Timisoara
country: Romania
facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
city: Moscow
country: Russian Federation
facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
city: Moscow
country: Russian Federation
facility: Vladimirskiy Regional Scientific Research Inst. ; Hematology
city: Saint-Petersburg
country: Russian Federation
facility: Almazov Federal Heart, Blood and Endocrinilogy Centre; Hematology department
city: Volgograd
country: Russian Federation
facility: Regional Oncology Center
city: Belgrade
country: Serbia
facility: Institute of Hematology
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocnica Roosevelta; Dept. of Haematology
city: Bratislava
country: Slovakia
facility: National Oncology Inst. ; Dept. of Haematology
city: Celje
country: Slovenia
facility: Hospital Celje; Haematology Dept
city: Ljubljana
country: Slovenia
facility: Clinical Center Ljubljana; Haematology Dept
city: Maribor
country: Slovenia
facility: Hospital Maribor; Haematology Dept
city: Vitoria
country: Spain
facility: Hospital De Txagorritxu; Servicio de Hematologia
state: Alava
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
state: Barcelona
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Logroño
country: Spain
facility: Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia
state: LA Rioja
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid; Servicio de Hematologia
state: Madrid
city: Caceres
country: Spain
facility: Hospital San Pedro De Alcantara; Servicio de Hematologia
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Infanta Leonor; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Hematología
city: Orense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Hematologia
city: Linkoeping
country: Sweden
facility: Universitetssjukhuset i Linköping, Hematologkliniken
city: Malmö
country: Sweden
facility: Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders
city: Uddevalla
country: Sweden
facility: Uddevalla Sjukhus; Medicinkliniken
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin
city: Basel
country: Switzerland
facility: Universitätsspital Basel; Hämatologie
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana (IOSI)
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden;Onkologie und Hämatologie
city: Geneve
country: Switzerland
facility: HUG; Hématologie
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital, Hämatologie
city: Zürich
country: Switzerland
facility: OnkoZentrum Zuerich
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Division of Hematology, Department of Medicine
city: Bangkok
country: Thailand
facility: Siriraj Hospital; Division of Hematology, Department of Medicine
city: Chiang Mai
country: Thailand
facility: Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
city: Adana
country: Turkey
facility: Cukurova Uni ; Hematology
city: Ankara
country: Turkey
facility: Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi
city: Ankara
country: Turkey
facility: Ankara University; Hematology
city: Denizli
country: Turkey
facility: Pamukkale Uni. Med. Fac.
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical School; Hematology
city: Istanbul
country: Turkey
facility: Istanbul Uni Capa Hospital; Hematology
city: Izmir
country: Turkey
facility: Dokuz Eylul Uni ; Hematology
city: Kayseri
country: Turkey
facility: Erciyes Uni ; Hematology
city: Samsun
country: Turkey
facility: Ondokuzmayis University Medical Faculty Heamatology Department
city: Trabzon
country: Turkey
facility: Karadeniz Technical Uni School of Medicine; Hematology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Stilgenbauer S, Bosch F, Ilhan O, Kisro J, Mahe B, Mikuskova E, Osmanov D, Reda G, Robinson S, Tausch E, Turgut M, Wojtowicz M, Bottcher S, Perretti T, Trask P, Van Hoef M, Leblond V, Foa R. Safety and efficacy of obinutuzumab alone or with chemotherapy in previously untreated or relapsed/refractory chronic lymphocytic leukaemia patients: Final analysis of the Phase IIIb GREEN study. Br J Haematol. 2021 Apr;193(2):325-338. doi: 10.1111/bjh.17326. Epub 2021 Feb 19.
citation: Bosch F, Cantin G, Cortelezzi A, Knauf W, Tiab M, Turgut M, Zaritskey A, Merot JL, Tausch E, Trunzer K, Robson S, Gresko E, Bottcher S, Foa R, Stilgenbauer S, Leblond V. Obinutuzumab plus fludarabine and cyclophosphamide in previously untreated, fit patients with chronic lymphocytic leukemia: a subgroup analysis of the GREEN study. Leukemia. 2020 Feb;34(2):441-450. doi: 10.1038/s41375-019-0554-1. Epub 2019 Aug 27.
citation: Stilgenbauer S, Leblond V, Foa R, Bottcher S, Ilhan O, Knauf W, Mikuskova E, Renner C, Tausch E, Woszczyk D, Gresko E, Lundberg L, Moore T, Morris T, Robson S, Bosch F. Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study. Leukemia. 2018 Aug;32(8):1778-1786. doi: 10.1038/s41375-018-0146-5. Epub 2018 Apr 27.