Chronic Lymphocytic Leukemia Clinical Trial

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

Summary

This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with leukemia-cll/" >chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
CLL requiring treatment according to IWCLL criteria
Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6
Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
Adequate liver function
Life expectancy > 6 months
Agreement to use highly effective contraceptive methods per protocol

Exclusion Criteria:

Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
Known central nervous system involvement
Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
Inadequate renal function
History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy
Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients
Pregnant women and nursing mothers
Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
Requires the use of warfarin, marcumar, or phenprocoumon
Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

445

Study ID:

NCT02242942

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 132 Locations for this study

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City of Hope
Duarte California, 91010, United States
San Diego Pacific Hematology Assocates
Encinitas California, 92024, United States
UC San Diego Health System
La Jolla California, 92093, United States
Banner MD Anderson Cancer Center
Greeley Colorado, 85234, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Winship Cancer Institute
Atlanta Georgia, 30322, United States
Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Joe Arrington Cancer Center
Lubbock Texas, 79410, United States
Hospital Italiano
Buenos Aires , C1181, Argentina
Liverpool Hospital
Liverpool New South Wales, 2170, Australia
Tweed Hospital
Tweed Heads New South Wales, 2485, Australia
The Townsville Hospital
Douglas Queensland, 4814, Australia
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba Queensland, 4102, Australia
Royal Adelaide Hospital; Haematology Clinical Trials
Adelaide South Australia, 5000, Australia
Ashford Cancer Centre Research; Internal Medicine/Medical Oncology
Ashford South Australia, 5035, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
The Northern Hospital
Epping Victoria, VIC 3, Australia
Monash Medical Centre; Haematology
Melbourne Victoria, 3168, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck , 6020, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
Wien , 1090, Austria
Hanusch-Krankenhaus; Iii. Medizinische Abt.
Wien , 1140, Austria
Wilhelminenspital; I. Medizinische Abt.
Wien , 1160, Austria
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP
Sao Paulo SP, 01236, Brazil
Hospital Sírio-Libanês
Sao Paulo SP, 01308, Brazil
Hospital das Clinicas - FMUSP
Sao Paulo SP, 05403, Brazil
Hospital Santa Marcelina
Sao Paulo SP, 08270, Brazil
UMHAT Dr Georgi Stranski; Hematology
Pleven , 5800, Bulgaria
UMHAT " Sveti Georgi" Plovdiv - Clinic of Oncology and Hematology
Plovdiv , 4002, Bulgaria
University Hospital Sv.Georgi Clnic of Hematology; Hematology
Plovdiv , 4002, Bulgaria
University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology
Sofia , 1431, Bulgaria
MHAT Hristo Botev; First Internal Department
Vratsa , 3000, Bulgaria
Tom Baker Cancer Centre; Dept of Medicine
Calgary Alberta, T2N 4, Canada
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax Nova Scotia, B3H 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
University Hospital Center Zagreb; Haematology Department
Zagreb , 10000, Croatia
University Hospital Merkur Clinic for Internal Medicine/ Hematology
Zagreb , 10000, Croatia
Herlev Hospital
Herlev , 2730, Denmark
Rigshospitalet
København Ø , 2100, Denmark
Sjællands Universitetshospital, Roskilde
Roskilde , 4000, Denmark
Sygehus Lillebælt, Vejle
Vejle , 7100, Denmark
North Estonia medical Centre; Hematology
Tallinn , 13419, Estonia
Tartu Uni Hospital; Hematology - Oncology Clinic
Tartu , 51014, Estonia
CHU Besançon - Hôpital Jean Minjoz
Besançon Cedex , 25030, France
Institut d'Hématologie de Basse Normandie
Caen , 14000, France
Chu Estaing; Hematologie Clinique Adultes
Clermont Ferrand , 63003, France
Hopital Henri Mondor
Creteil , 94000, France
CHU de Dijon - Hopital le Bocage
Dijon , 21000, France
CHU de Grenoble
Grenoble , 38043, France
Centre Jean Bernard
Le Mans , 72015, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon , 69373, France
Hôpital Saint Eloi; Service d'Hématologie et Oncologie Clinique - Recherche Clinique
Montpellier , 34295, 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 Pontchaillou; Hematologie Clinique
Rennes , 35033, France
Centre Henri Becquerel; Hematologie
Rouen , 76038, France
CH de Toulon Hôpital Sainte Musse
Toulon , 83056, France
Institut Gustave Roussy - Hematologie
Villejuif , 94805, France
Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.
Aachen , 52074, Germany
Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
Amberg , 92224, Germany
Charite - Universitätsmedizin Berlin
Berlin , 12203, Germany
Charite - Campus Virchow-Klinikum
Berlin , 13353, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden , 01307, Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
Dresden , 01307, Germany
Universitätsklinikum Essen; Klinik für Hämatologie
Essen , 45122, Germany
Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie
Esslingen , 73730, Germany
Klinikum Frankfurt/Oder
Frankfurt/Oder , 15236, Germany
Uniklinikum Freiburg
Freiburg , 79106, Germany
Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie
Göttingen , 37075, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte
Herne , 44625, Germany
Praxisklinik für Hämatologie und Onkologie Koblenz
Koblenz , 56068, Germany
Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie
Köln , 50931, Germany
Tagesklinik Landshut; Hämatologie/Onkologie
Landshut , 84028, Germany
Klinikum rechts der Isar der Technischen Universität München
Munchen , 81675, Germany
Klinikum Schwäbisch Gmünd
Mutlangen , 73557, Germany
Kliniken Maria Hilf GmbH; Innere Medizin I; Hämatologie und internistische Onkologie
Mönchengladbach , 41063, Germany
München Klinik Schwabing; Klinik für Hämatologie, Onkologie, Immunologie
München , 80804, Germany
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
München , 81377, Germany
Gemeinschaftspraxis Dr. med. Holger Klaproth
Neunkirchen/Saar , 66538, Germany
Brüderkrankenhaus St. Josef Paderborn
Paderborn , 33098, Germany
Krankenhaus Barmherzige Bruder Regensburg
Regensburg , 93049, Germany
Marienhospital
Stuttgart , 70199, Germany
Robert-Bosch-Krankenhaus
Stuttgart , 70376, Germany
Universitätsklinikum Tübingen
Tübingen , 72076, Germany
Universtitätsklinikum Ulm; Klinik für Innere Medizin III
Ulm , 89081, Germany
Medizinisches Versorgungszentrum Nuklearmedizin-Strahlentherapie-Onkologie
Weiden , 92367, Germany
Arcispedale S. Anna; Sezione Di Ematologia
Ferrara Emilia-Romagna, 44100, Italy
Ospedali Riuniti Papardo-Piemonte; Struttura Complessa Di Ematologia
Messina Lazio, 98158, Italy
Uni Cattolica; Divisione Di Ematologia
Roma Lazio, 00168, Italy
AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette
Torino Lazio, 10126, Italy
Ospedale San Raffaele
Milano Lombardia, 20132, Italy
Az. Osp. S. Maria; Dept. Di Oncologia Medica
Terni Umbria, 05100, Italy
Ospedale dell' Angelo; U.O. Ematologia
Venezia Mestre Veneto, 30174, Italy
Hospital General de Culiacan
Culiacan , 80230, Mexico
Canterbury Health Laboratories; Haematology
Christchurch , 8011, New Zealand
Dunedin Hospital
Dunedin , , New Zealand
Midcentral District Health Board
Palmerston North , 4442, New Zealand
Wellington Hospital
Wellington , 6012, New Zealand
Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Hematologii z Pododdziałem Chorob Naczyn
Bialystok , 15-2, Poland
Samodzielny Public Zaklad
Chorzów , 41-50, Poland
Wojewódzki Szpital Specjalistyczny im.MikołajaKopernika;KlinikaHematologiiUniwersytetuMedycznego
Lodz , 9351, Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny
Slupsk , 76-20, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu; Klinika Hematologii
Wroclaw , 5036, Poland
Fundeni Clinical Inst. ; Hematology Dept
Bucharest , 02232, Romania
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
Iasi , 70048, Romania
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
Targu-mures , 54013, Romania
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
Kazan , 42002, Russian Federation
Moscow State Budgetary Healthcare Institution
Moscow , 12318, Russian Federation
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod , 60312, Russian Federation
Penza Regional Oncology Dispensary
Penza , 44007, Russian Federation
Clinical MSCh No1
Perm , 61407, Russian Federation
Rostov State Medical Uni ; Hematology
Rostov-na-donu , 34402, Russian Federation
SBEI of HPE "Bashkir State Medical University" of MoH RF
Ufa , 45000, Russian Federation
Complejo Hospitalario de Navarra
Pamplona Navarra, 31008, Spain
Hospital Universitario de Canarias;servicio de Hematologia
La Laguna Tenerife, 38320, Spain
Hospital del Mar; Servicio de Hematologia
Barcelona , 08003, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona , 08035, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona , 08036, Spain
Hospital Universitario de la Princesa; Servicio de Hematologia
Madrid , 28006, Spain
Hospital Universitario La Paz
Madrid , 28034, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Univ. 12 de Octubre; Servicio de Hematologia
Madrid , 28041, Spain
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
Salamanca , 37007, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología
Toledo , 45004, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia , 46010, Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia
Valencia , 46015, Spain
Inselspital Bern; Hämatologie und Hämatologisches Zentrallabor
Bern , 3010, Switzerland
Luzerner Kantonsspital, Hämatologie
Luzern , 6000, Switzerland
Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie
Zürich , 8091, Switzerland
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Boston Pilgrim Hospital
Boston,Lincolnshire , PE21 , United Kingdom
Western General Hospital; Department of Haematology
Edinburgh , EH4 2, United Kingdom
Lincoln County Hospital
Lincoln , LN2 5, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southhampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

445

Study ID:

NCT02242942

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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