A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
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
2 other identifiers
interventional
979
28 countries
166
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2013
Longer than P75 for phase_3
166 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2013
CompletedFirst Posted
Study publicly available on registry
July 23, 2013
CompletedStudy Start
First participant enrolled
November 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2018
CompletedResults Posted
Study results publicly available
October 29, 2018
CompletedOctober 28, 2019
October 1, 2019
3.2 years
July 19, 2013
December 21, 2017
October 24, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Baseline up to time of primary completion (3 years)
Number of Participants With Adverse Events of Special Interest (AESIs)
The following AEs were defined as AESIs: AEs with the preferred term Tumour Lysis Syndrome (TLS), Infusion-Related Reactions (IRRs) defined as AEs that occurred during or within 24 hours of the completion of obinutuzumab infusion and were assessed as related to obinutuzumab by the Investigator, Infections defined as AEs from System Organ Class (SOC) "Infections and infestations" and AEs with the preferred term Neutropenia. Reported are number of participants with total AESIs, IRRs, Infections, Neutropenia and TLS.
Baseline up to time of primary completion (3 years)
Number of Participants With Adverse Events of Particular Interest (AEPIs)
The following AEs were defined as AEPIs: AEs with the preferred term Progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation defined as AEs with preferred term containing "Hepatitis B" or "hepatitis acute", thrombocytopenia defined via Roche MedDRA basket subgroup "haematopoietic thrombocytopenia", second malignancies defined as AEs from the SOC "Neoplasms benign, malignant and unspecified" starting 6 months after the first study drug intake, second malignancies based on standardised MedDRA queries (SMQ) starting 6 months after the first study drug intake based on the MedDRA SMQ "Malignant or unspecified tumours", in which benign neoplasms are not included, Cardiac events including AEs from the SOC "Cardiac disorders", and hemorrhagic events defined via Roche MedDRA basket subgroup "Haemorrhagic events". Reported are number of participants with total AEPIs and each of the AEPI categories.
Baseline up to time of primary completion (3 years)
Secondary Outcomes (9)
Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA)
3 months after the last dose of study treatment (up to approximately 5 years)
Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry
3 months after the last dose of study treatment (up to approximately 5 years)
Percentage of Participants With Best Overall Response (BOR)
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)
Median Time to Progression-Free Survival (PFS)
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)
Median Time to Response (TTR)
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)
- +4 more secondary outcomes
Study Arms (1)
Obinutuzumab
EXPERIMENTALParticipants will receive obinutuzumab either alone as single agent or in combination with chemotherapy (Fludarabine/Cyclophosphamide \[FC\], Bendamustine or Chlorambucil) at the investigator's discretion. Each cycle is of 28-days duration.
Interventions
Bendamustine: 90 milligram per millilitre square (mg/m\^2) IV over 60 minutes once daily (QD) Day 1-2 in participants previously untreated or 70 mg/m\^2 I.V. over 60 minutes QD Day 1-2 in participants with relapsed/refractory disease. In non-fit participants only, investigators may opt at their own discretion to use lower initial doses of bendamustine, i.e., bendamustine 70 mg/m\^2 in previously untreated participants, and bendamustine 50 mg/m\^2 in relapsed/refractory subjects (over 60 minutes qd Day 1-2 for each administration).
Chlorambucil 0.5 mg/kg p.o. qd on Day 1 and Day 15 in non-fit participants only.
Cyclophosphamide 250 mg/m\^2 I.V. over 15-30 minutes qd Day 1-3 or Cyclophosphamide 250 mg/m\^2 p.o. QD Day 1-3 in fit participants only.
Fludarabine 25 mg/m\^2 I.V. over 30 minutes QD Day 1-3 or Fludarabine 40 mg/m\^2 per os (p.o.) QD Day 1-3 in fit participants only.
Participants will receive obinutuzumab 1000 mg IV infusion on Days 1/2 (dose split over 2 consecutive days; 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1, and on Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle is of 28-days duration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (174)
Hospital Iturraspe
Santa Fé, 3000, Argentina
Hospital Erasme; Neurologie
Brussels, 1070, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
Banja Luka, 88000, Bosnia and Herzegovina
University Clinical Center Sarajevo, Clinic for Hematology
Sarajevo, 71000, Bosnia and Herzegovina
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP
São Paulo, São Paulo, 01236-030, Brazil
Hospital Sirio Libanes; Centro de Oncologia
São Paulo, São Paulo, 01308-050, Brazil
Hospital Estadual do Servidor Publico; Hematologia
São Paulo, São Paulo, 04029-000, Brazil
Hospital das Clinicas - FMUSP; Hematologia
São Paulo, São Paulo, 05403-000, Brazil
Hospital Santa Marcelina;Oncologia
São Paulo, São Paulo, 08270-070, Brazil
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Regional health authority A vitalite health network
Moncton, New Brunswick, E1C 8X3, Canada
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, B3H 2Y9, Canada
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
Barrie, Ontario, L4M 6M2, Canada
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
Greenfield Park, Quebec, J4V 2H1, Canada
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, H1T 2M4, Canada
Centre de sante et de services sociaux Rimouski Neigette
Rimouski, Quebec, G5L 5T1, Canada
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, S7N 4H4, Canada
CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie
Québec, G1J 1Z4, Canada
Cairo University Hospital Al Kasr El Ainy
Cairo, 11559, Egypt
National Cancer Institute
Cairo, 11796, Egypt
North Estonia Regional Hospital; Hematology
Tallinn, 13419, Estonia
Tartu Uni Hospital; Hematology - Oncology Clinic
Tartu, 51014, Estonia
Kuopio University Hospital
Kuopio, 70211, Finland
Tampere University Hospital; Hematology
Tampere, 33521, Finland
Turku Uni Central Hospital; Dept of Internal Medicine
Turku, 20520, Finland
Hotel Dieu; Medecine D
Angers, 49933, France
Ch Victor Dupouy; Hematologie
Argenteuil, 95107, France
Hopital Augustin Morvan; Hematologie
Brest, 29609, France
Hopital Cote De Nacre; Hematologie Biologique
Caen, 14033, France
Chu Estaing; Hematologie Clinique Adultes
Clermont-Ferrand, 63003, France
Hopital Henri Mondor; Hematologie Clinique
Créteil, 94010, France
Chu Site Du Bocage;Hematologie Clinique
Dijon, 21079, France
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, 85925, France
Ch Du Mans; Medecine Hematologie Oncologie
Le Mans, 72037, France
Hopital Claude Huriez; Hematologie
Lille, 59037, France
Hopital Uni Ire Dupuytren; Hematologie
Limoges, 87042, France
Hopital Saint Eloi; Hematologie Oncologie Medicale
Montpellier, 34295, France
Hopital Emile Muller; Hematologie
Mulhouse, 68070, France
Hopital Hotel Dieu Et Hme;Hopital De Jour
Nantes, 44093, France
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
Paris, 75475, France
Hopital Saint Antoine; Hematologie Clinique
Paris, 75571, France
Hopital Pitie Salpetriere; Hematologie Clinique
Paris, 75651, France
Hopital Saint Jean; Hematologie
Perpignan, 66046, France
Hopital De Haut Leveque; Hematologie Clinique
Pessac, 33604, France
Ch Lyon Sud; Hemato Secteur Jules Courmont
Pierre-Bénite, 69495, France
Centre Hospitalier René Dubos; Hematologie
Pontoise, 95300, France
Hopital Robert Debre; Hematologie Clinique
Reims, 51092, France
Centre Henri Becquerel; Hematologie
Rouen, 76038, France
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll
Saint-Brieuc, 22027, France
Hopital Bretonneau; Hematologie Therapie Cellulaire
Tours, 37044, France
Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter
Augsburg, 86150, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, 01307, Germany
Onkologisches Zentrum am Bethanien-Kankenhaus
Frankfurt, 60389, Germany
Gemeinschaftspraxis; Prof. Dr. Michael Kiehl und Dr.med. Wolfgang Stein
Frankfurt (Oder), 15236, Germany
Dres.Andreas Ammon und Dirk Meyer
Göttingen, 37073, Germany
OncoResearch Lerchenfeld GmbH
Hamburg, 22081, Germany
Onkologische Schwerpunktpraxis Lübeck
Lübeck, 23562, Germany
Onkologische Gemeinschaftspraxis
Magdeburg, 39104, Germany
Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
Mutlangen, 73557, Germany
Dres. Hans-Dieter Schick Dorothea Schick Burkhard Schmidt u.w.
München, 81241, Germany
Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura
Neunkirchen/Saar, 66538, Germany
eps - early phase GmbH
Pößneck, 07381, Germany
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
Recklinghausen, 45659, Germany
Schwerpunktpraxis & Tagesklinik f. Hämatologie & Onkologie Regensdorf / Schwandorf / Wörth
Regensburg, 93053, Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Ulm, 89081, Germany
Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker
Würzburg, 97080, Germany
General Hospital of Athens Evangelismos; Hematology
Athens, 106 76, Greece
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
Athens, 115 27, Greece
Laiko General Hospital; Hematology Clinic
Athens, 115 27, Greece
University Hospital of Ioannina; Hematology
Ioannina, 455 00, Greece
Georgios Papanikolaou Hospital; Hematology Department
Thessaloniki, 570 10, Greece
Mater Misericordiae Uni Hospital; Oncology
Dublin, 7, Ireland
University Hospital Limerick - Oncology
Limerick, Ireland
Waterford Regional Hospital; Department Of Medical Oncology
Waterford, Ireland
Soroka Medical Center; Hematology Deptartment
Beersheba, 8410101, Israel
Bnei-Zion Medical Center; Hematology Dept
Haifa, 3339419, Israel
Hadassah Ein Karem Hospital; Haematology
Jerusalem, 9112001, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Ichilov Sourasky Medical Center; Heamatology
Tel Aviv, 6423906, Israel
Azienda ospedaliera oo rr di foggi; Hematology
Foggia, Apulia, 71100, Italy
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce, Apulia, 73100, Italy
Az. Osp. Pugliese; Divisione de Ematologia
Catanzaro, Calabria, 88100, Italy
Ospedale Cardarelli; Divisione Di Ematologia
Napoli, Campania, 80131, Italy
Arcispedale S. Anna; Sezione Di Ematologia
Ferrara, Emilia-Romagna, 44100, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia
Modena, Emilia-Romagna, 41100, Italy
AUSL di Piacenza - Ospedale "Guglielmo da Saliceto";U.O. Ematologia
Piacenza, Emilia-Romagna, 29121, Italy
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
Ravenna, Emilia-Romagna, 48100, Italy
Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia
Rimini, Emilia-Romagna, 47900, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
Rome, Lazio, 00161, Italy
Uni Degli Studi Di Genova; 1A Divisione Di Ematologia
Genoa, Liguria, 16132, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milan, Lombardy, 20122, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia
Milan, Lombardy, 20162, Italy
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
Novara, Piedmont, 28100, Italy
Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I
Turin, Piedmont, 10126, Italy
Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
Cagliari, Sardinia, 09121, Italy
Azienda USL 6 Livorno - P.O. Livorno; U.O. Ematologia Clinica
Livorno, Tuscany, 57124, Italy
RECUH, Oncology Centre of Latvia; Clinic of Chemotherapy and Heamatology
Riga, 1079, Latvia
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, 50009, Lithuania
Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center
Vilnius, 08661, Lithuania
Hospital General De Culiacan; Servicio De Hematologia
Culiacán, 80230, Mexico
Hospital General de México; Haematology
Mexico City, 06726, Mexico
Centro Medico Nacional Sxxi - Imss; Haematology
Mexico City, 11270, Mexico
Hospital Universitario Dr. Jose E. Gonzalez; Haematology
Monterrey, 64460, Mexico
Centro de Estudios Clinicos de Queretaro (CECLIQ)
Querétaro, 76000, Mexico
University Clinic of Hematology Skopje, Hospital Care Department
Skopje, 1000, North Macedonia
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
Lublin, 20-081, Poland
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, 10-228, Poland
Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej
Opole, 45-061, Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny
Słupsk, 76-200, Poland
Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula
Lisbon, 1600, Portugal
IPO do Porto; Servico de Onco-Hematologia
Porto, 4200-072, Portugal
Policlinica de Diagnostic Rapid
Brasov, 500152, Romania
Spitalul Clinic Judetean de Urgenta Brasov; Clinica de Hematologie
Brasov, 500326, Romania
Spitalul Clinic Coltea; Clinica de Hematologie
Bucharest, 030171, Romania
Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
Timișoara, 300079, Romania
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
Moscow, 115478, Russia
Vladimirskiy Regional Scientific Research Inst. ; Hematology
Moscow, 129110, Russia
Almazov Federal Heart, Blood and Endocrinilogy Centre; Hematology department
Saint Petersburg, 197341, Russia
Regional Oncology Center
Volgograd, 400138, Russia
Institute of Hematology
Belgrade, 11000, Serbia
Fakultna Nemocnica Roosevelta; Dept. of Haematology
Banská Bystrica, 975 17, Slovakia
National Oncology Inst. ; Dept. of Haematology
Bratislava, 833 10, Slovakia
Hospital Celje; Haematology Dept
Celje, 3000, Slovenia
Clinical Center Ljubljana; Haematology Dept
Ljubljana, 1525, Slovenia
Hospital Maribor; Haematology Dept
Maribor, 2000, Slovenia
Pusan University Hospital
Busan, 602-739, South Korea
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, 03080, South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710, South Korea
Hospital De Txagorritxu; Servicio de Hematologia
Vitoria-Gasteiz, Alava, 01009, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
Badalona, Barcelona, 08915, Spain
Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia
Logroño, La Rioja, 26006, Spain
Hospital Quiron de Madrid; Servicio de Hematologia
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital San Pedro De Alcantara; Servicio de Hematologia
Cáceres, 10003, Spain
Hospital Universitario Reina Sofia; Servicio de Hematologia
Córdoba, 14004, Spain
Hospital Infanta Leonor; Servicio de Hematologia
Madrid, 28031, Spain
Hospital Universitario Clínico San Carlos; Servicio de Hematología
Madrid, 28040, Spain
Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia
Ourense, 32005, Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia
Seville, 41013, Spain
Hospital Universitario la Fe; Servicio de Hematologia
Valencia, 46026, Spain
Universitetssjukhuset i Linköping, Hematologkliniken
Linköping, 581 85, Sweden
Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders
Malmo, 212 24, Sweden
Uddevalla Sjukhus; Medicinkliniken
Uddevalla, 45180, Sweden
Akademiska Sjukhuset
Uppsala, 751 85, Sweden
Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin
Aarau, 5001, Switzerland
Universitätsspital Basel; Hämatologie
Basel, 4031, Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, 6500, Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, 7000, Switzerland
HUG; Hématologie
Geneva, 1211, Switzerland
Luzerner Kantonsspital, Hämatologie
Lucerne, 6000, Switzerland
OnkoZentrum Zuerich
Zurich, 8038, Switzerland
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
Bangkok, 10330, Thailand
Ramathibodi Hospital; Division of Hematology, Department of Medicine
Bangkok, 10400, Thailand
Siriraj Hospital; Division of Hematology, Department of Medicine
Bangkok, 10700, Thailand
Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine
Chiang Mai, 50200, Thailand
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
Khon Kaen, 40002, Thailand
Cukurova Uni ; Hematology
Adana, 01330, Turkey (Türkiye)
Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi
Ankara, 06100, Turkey (Türkiye)
Ankara University; Hematology
Ankara, 06620, Turkey (Türkiye)
Pamukkale Uni. Med. Fac.
Denizli, 20070, Turkey (Türkiye)
Gaziantep University Medical School; Hematology
Gaziantep, 27310, Turkey (Türkiye)
Istanbul Uni Capa Hospital; Hematology
Istanbul, 34390, Turkey (Türkiye)
Dokuz Eylul Uni ; Hematology
Izmir, 35100, Turkey (Türkiye)
Erciyes Uni ; Hematology
Kayseri, 38039, Turkey (Türkiye)
Ondokuzmayis University Medical Faculty Heamatology Department
Samsun, 55139, Turkey (Türkiye)
Karadeniz Technical Uni School of Medicine; Hematology
Trabzon, 61800, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 33605445DERIVEDBosch 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.
PMID: 31455851DERIVEDStilgenbauer 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.
PMID: 29749403DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2013
First Posted
July 23, 2013
Study Start
November 4, 2013
Primary Completion
December 29, 2016
Study Completion
October 8, 2018
Last Updated
October 28, 2019
Results First Posted
October 29, 2018
Record last verified: 2019-10