A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905943
• Other study ID #: MO28543
• Secondary ID: 2013-000087-29
• Status: Completed
• Phase: Phase 3
• Start date: November 4, 2013
• Est. completion date: October 8, 2018

Study information

• Verified date: October 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 979
• Est. completion date: October 8, 2018
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Bendamustine
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
Chlorambucil 0.5 mg/kg p.o. qd on Day 1 and Day 15 in non-fit participants only.
• Cyclophosphamide
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
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.
• Obinutuzumab
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.

Locations

Country	Name	City	State
Argentina	Hospital Iturraspe	Santa Fé
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	Hospital Erasme; Neurologie	Bruxelles
Belgium	Jessa Zkh (Campus Virga Jesse)	Hasselt
Belgium	CHU Sart-Tilman	Liège
Belgium	Sint Augustinus Wilrijk	Wilrijk
Bosnia and Herzegovina	University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept	Banja Luka
Bosnia and Herzegovina	University Clinical Center Sarajevo, Clinic for Hematology	Sarajevo
Brazil	Hospital de Cancer de Barretos	Barretos	SP
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Hospital das Clinicas - FMUSP; Hematologia	Sao Paulo	SP
Brazil	Hospital Estadual do Servidor Publico; Hematologia	Sao Paulo	SP
Brazil	Hospital Santa Marcelina;Oncologia	Sao Paulo	SP
Brazil	Hospital Sirio Libanes; Centro de Oncologia	Sao Paulo	SP
Brazil	Instituto de Ensino e Pesquisa Sao Lucas - IEP	Sao Paulo	SP
Canada	Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials	Barrie	Ontario
Canada	Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie	Greenfield Park	Quebec
Canada	Queen Elizabeth II Health Sciences Centre; Oncology	Halifax	Nova Scotia
Canada	Regional health authority A vitalite health network	Moncton	New Brunswick
Canada	Hopital Maisonneuve- Rosemont; Oncology	Montreal	Quebec
Canada	CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie	Quebec
Canada	Centre de sante et de services sociaux Rimouski Neigette	Rimouski	Quebec
Canada	Saskatoon Cancer Centre; Uni of Saskatoon Campus	Saskatoon	Saskatchewan
Canada	Cancer Care Manitoba	Winnipeg	Manitoba
Egypt	Cairo University Hospital Al Kasr El Ainy	Cairo
Egypt	National Cancer Institute	Cairo
Estonia	North Estonia Regional Hospital; Hematology	Tallinn
Estonia	Tartu Uni Hospital; Hematology - Oncology Clinic	Tartu
Finland	Kuopio University Hospital	Kuopio
Finland	Tampere University Hospital; Hematology	Tampere
Finland	Turku Uni Central Hospital; Dept of Internal Medicine	Turku
France	Hotel Dieu; Medecine D	Angers
France	Ch Victor Dupouy; Hematologie	Argenteuil
France	Hopital Augustin Morvan; Hematologie	Brest
France	Hopital Cote De Nacre; Hematologie Biologique	Caen
France	Chu Estaing; Hematologie Clinique Adultes	Clermont Ferrand
France	Hopital Henri Mondor; Hematologie Clinique	Creteil
France	Chu Site Du Bocage;Hematologie Clinique	Dijon
France	Centre Hospitalier Departemental Les Oudairies	La Roche Sur Yon
France	Ch Du Mans; Medecine Hematologie Oncologie	Le Mans
France	Hopital Claude Huriez; Hematologie	Lille
France	Hopital Uni Ire Dupuytren; Hematologie	Limoges
France	Hopital Saint Eloi; Hematologie Oncologie Medicale	Montpellier
France	Hopital Emile Muller; Hematologie	Mulhouse
France	Hopital Hotel Dieu Et Hme;Hopital De Jour	Nantes
France	Hopital Pitie Salpetriere; Hematologie Clinique	Paris
France	Hopital Saint Antoine; Hematologie Clinique	Paris
France	Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)	Paris
France	Hopital Saint Jean; Hematologie	Perpignan
France	Hopital De Haut Leveque; Hematologie Clinique	Pessac
France	Ch Lyon Sud; Hemato Secteur Jules Courmont	Pierre Benite
France	Centre Hospitalier René Dubos; Hematologie	Pontoise
France	Hopital Robert Debre; Hematologie Clinique	Reims
France	Centre Henri Becquerel; Hematologie	Rouen
France	Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll	St Brieuc
France	Hopital Bretonneau; Hematologie Therapie Cellulaire	Tours
Germany	Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter	Augsburg
Germany	BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie	Dresden
Germany	Onkologisches Zentrum am Bethanien-Kankenhaus	Frankfurt
Germany	Gemeinschaftspraxis; Prof. Dr. Michael Kiehl und Dr.med. Wolfgang Stein	Frankfurt an der Oder
Germany	Dres.Andreas Ammon und Dirk Meyer	Göttingen
Germany	OncoResearch Lerchenfeld GmbH	Hamburg
Germany	Onkologische Schwerpunktpraxis Lübeck	Lübeck
Germany	Onkologische Gemeinschaftspraxis	Magdeburg
Germany	Dres. Hans-Dieter Schick Dorothea Schick Burkhard Schmidt u.w.	München
Germany	Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin	Mutlangen
Germany	Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura	Neunkirchen/Saar
Germany	eps - early phase GmbH	Pößneck
Germany	Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie	Recklinghausen
Germany	Schwerpunktpraxis & Tagesklinik f. Hämatologie & Onkologie Regensdorf / Schwandorf / Wörth	Regensburg
Germany	Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.	Ulm
Germany	Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker	Würzburg
Greece	General Hospital of Athens Evangelismos; Hematology	Athens
Greece	Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine	Athens
Greece	Laiko General Hospital; Hematology Clinic	Athens
Greece	University Hospital of Ioannina; Hematology	Ioannina
Greece	Georgios Papanikolaou Hospital; Hematology Department	Thessaloniki
Ireland	Mater Misericordiae Uni Hospital; Oncology	Dublin
Ireland	University Hospital Limerick - Oncology	Limerick
Ireland	Waterford Regional Hospital; Department Of Medical Oncology	Waterford
Israel	Soroka Medical Center; Hematology Deptartment	Beer Sheva
Israel	Bnei-Zion Medical Center; Hematology Dept	Haifa
Israel	Hadassah Ein Karem Hospital; Haematology	Jerusalem
Israel	Kaplan Medical Center	Rehovot
Israel	Ichilov Sourasky Medical Center; Heamatology	Tel Aviv
Italy	Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.	Cagliari	Sardegna
Italy	Az. Osp. Pugliese; Divisione de Ematologia	Catanzaro	Calabria
Italy	Arcispedale S. Anna; Sezione Di Ematologia	Ferrara	Emilia-Romagna
Italy	Azienda ospedaliera oo rr di foggi; Hematology	Foggia	Puglia
Italy	Uni Degli Studi Di Genova; 1A Divisione Di Ematologia	Genova	Liguria
Italy	Ospedale Vito Fazzi; Div. Oncoematologia	Lecce	Puglia
Italy	Azienda USL 6 Livorno - P.O. Livorno; U.O. Ematologia Clinica	Livorno	Toscana
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia	Milano	Lombardia
Italy	Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora	Milano	Lombardia
Italy	A.O. Universitaria Policlinico Di Modena; Ematologia	Modena	Emilia-Romagna
Italy	Ospedale Cardarelli; Divisione Di Ematologia	Napoli	Campania
Italy	Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad	Novara	Piemonte
Italy	AUSL di Piacenza - Ospedale "Guglielmo da Saliceto";U.O. Ematologia	Piacenza	Emilia-Romagna
Italy	Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia	Ravenna	Emilia-Romagna
Italy	Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia	Rimini	Emilia-Romagna
Italy	Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol	Roma	Lazio
Italy	Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I	Torino	Piemonte
Korea, Republic of	Pusan University Hospital	Busan
Korea, Republic of	Samsung Medical Centre; Division of Hematology/Oncology	Seoul
Korea, Republic of	Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology	Seoul
Latvia	RECUH, Oncology Centre of Latvia; Clinic of Chemotherapy and Heamatology	Riga
Lithuania	Hospital of Lithuanian University of Health. Sciences Kaunas Clinics	Kaunas
Lithuania	Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center	Vilnius
Mexico	Hospital General De Culiacan; Servicio De Hematologia	Culiacan
Mexico	Centro Medico Nacional Sxxi - Imss; Haematology	Mexico City
Mexico	Hospital General de México; Haematology	Mexico City
Mexico	Hospital Universitario Dr. Jose E. Gonzalez; Haematology	Monterrey
Mexico	Centro de Estudios Clinicos de Queretaro (CECLIQ)	Queretaro
North Macedonia	University Clinic of Hematology Skopje, Hospital Care Department	Skopje
Poland	Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie	Lublin
Poland	Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie	Olsztyn
Poland	Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej	Opole
Poland	Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddzial Chorób Wewnetrznych/Hematologiczny	Slupsk
Portugal	Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula	Lisboa
Portugal	IPO do Porto; Servico de Onco-Hematologia	Porto
Romania	Policlinica de Diagnostic Rapid	Brasov
Romania	Spitalul Clinic Judetean de Urgenta Brasov; Clinica de Hematologie	Brasov
Romania	Spitalul Clinic Coltea; Clinica de Hematologie	Bucuresti
Romania	Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie	Timisoara
Russian Federation	FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF	Moscow
Russian Federation	Vladimirskiy Regional Scientific Research Inst. ; Hematology	Moscow
Russian Federation	Almazov Federal Heart, Blood and Endocrinilogy Centre; Hematology department	Saint-Petersburg
Russian Federation	Regional Oncology Center	Volgograd
Serbia	Institute of Hematology	Belgrade
Slovakia	Fakultna Nemocnica Roosevelta; Dept. of Haematology	Banska Bystrica
Slovakia	National Oncology Inst. ; Dept. of Haematology	Bratislava
Slovenia	Hospital Celje; Haematology Dept	Celje
Slovenia	Clinical Center Ljubljana; Haematology Dept	Ljubljana
Slovenia	Hospital Maribor; Haematology Dept	Maribor
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia	Badalona	Barcelona
Spain	Hospital San Pedro De Alcantara; Servicio de Hematologia	Caceres
Spain	Hospital Universitario Reina Sofia; Servicio de Hematologia	Cordoba
Spain	Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia	Logroño	LA Rioja
Spain	Hospital Infanta Leonor; Servicio de Hematologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Hematología	Madrid
Spain	Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia	Orense
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Hospital Quiron de Madrid; Servicio de Hematologia	Pozuelo de Alarcon	Madrid
Spain	Hospital Universitario Virgen del Rocio; Servicio de Hematologia	Sevilla
Spain	Hospital Universitario la Fe; Servicio de Hematologia	Valencia
Spain	Hospital De Txagorritxu; Servicio de Hematologia	Vitoria	Alava
Sweden	Universitetssjukhuset i Linköping, Hematologkliniken	Linkoeping
Sweden	Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders	Malmö
Sweden	Uddevalla Sjukhus; Medicinkliniken	Uddevalla
Sweden	Akademiska Sjukhuset	Uppsala
Switzerland	Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin	Aarau
Switzerland	Universitätsspital Basel; Hämatologie	Basel
Switzerland	Istituto Oncologico della Svizzera Italiana (IOSI)	Bellinzona
Switzerland	Kantonsspital Graubünden;Onkologie und Hämatologie	Chur
Switzerland	HUG; Hématologie	Geneve
Switzerland	Luzerner Kantonsspital, Hämatologie	Luzern
Switzerland	OnkoZentrum Zuerich	Zürich
Thailand	King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine	Bangkok
Thailand	Ramathibodi Hospital; Division of Hematology, Department of Medicine	Bangkok
Thailand	Siriraj Hospital; Division of Hematology, Department of Medicine	Bangkok
Thailand	Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine	Chiang Mai
Thailand	Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine	Khon Kaen
Turkey	Cukurova Uni ; Hematology	Adana
Turkey	Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi	Ankara
Turkey	Ankara University; Hematology	Ankara
Turkey	Pamukkale Uni. Med. Fac.	Denizli
Turkey	Gaziantep University Medical School; Hematology	Gaziantep
Turkey	Istanbul Uni Capa Hospital; Hematology	Istanbul
Turkey	Dokuz Eylul Uni ; Hematology	Izmir
Turkey	Erciyes Uni ; Hematology	Kayseri
Turkey	Ondokuzmayis University Medical Faculty Heamatology Department	Samsun
Turkey	Karadeniz Technical Uni School of Medicine; Hematology	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Belgium,  Bosnia and Herzegovina,  Brazil,  Canada,  Egypt,  Estonia,  Finland,  France,  Germany,  Greece,  Ireland,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  North Macedonia,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA)	OR: percentage of participants with complete response (CR) or CR with incomplete marrow recovery (CRi), or partial response (PR), as determined by the investigator based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. Cri: CR with persistent cytopenia. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin.	3 months after the last dose of study treatment (up to approximately 5 years)
Secondary	Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry	MRD-negativity was defined as the presence of less than 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes in blood and bone marrow as assessed by flow cytometry 3 months after last dose of study treatment (i.e. at final response assessment [FRA] visit).	3 months after the last dose of study treatment (up to approximately 5 years)
Secondary	Percentage of Participants With Best Overall Response (BOR)	BOR was defined as the percentage of participants with the best response obtained throughout the trial with CR, CRi, or PR, as determined by the investigator based on IWCLL tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. Cri: CR with persistent cytopenia. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin.	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)
Secondary	Median Time to Progression-Free Survival (PFS)	Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on IWCLL tumor response criteria or died from any cause, whichever occurred first. PD: at least one of the following: >/= 50% increase in the absolute number of circulating lymphocytes to at least 5,000/mcL, appearance of new palpable lymph nodes, >/= 50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, >/= 50% increase in the enlargement of the liver and/or spleen, transformation to more aggressive histology, progression of any cytopenia, decrease of hemoglobin levels by more than 20 g/L or to less than 100 g/L, decrease of platelet counts by more than 50% or to less than 100,000 /mcL, decrease of neutrophil counts by more than 50% or to less than 1,000/mcL.	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)
Secondary	Median Time to Response (TTR)	Kaplan Meier estimate of median TTR was defined as the time at which half of the participants reached CR or PR based on IWCLL tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin.	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)
Secondary	Median Time to Event-Free Survival (EFS)	Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed as assessed by investigator based on IWCLL tumor response criteria, or have initiated a non-protocol-specified anti-leukemia therapy or died, whichever occurs first. PD: at least 1 of the following: >/= 50% increase in absolute number of circulating lymphocytes to at least 5,000/mcL, appearance of new palpable lymph nodes, >/= 50% increase in longest diameter of any previous site of clinically significant lymphadenopathy, >/= 50% increase in enlargement of liver and/or spleen, transformation to more aggressive histology, progression of any cytopenia, decrease of hemoglobin levels by more than 20 g/L or to less than 100 g/L, decrease of platelet counts by more than 50% or to less than 100,000 /mcL, decrease of neutrophil counts by more than 50% or to less than 1,000/mcL.	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)
Secondary	Median Time to Overall Survival (OS)	Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.	Baseline until death (Approximately up to 5 years)
Secondary	Median Time to New Anti-Leukemia Therapy (TTNT)	Kaplan Meier estimate of median TTNT was defined as the time at which half of the participants have initiated a new anti-leukemic therapy.	Baseline until end of study (up to approximately 5 years)
Secondary	Median Time to Duration of Response (DoR)	Kaplan Meier estimate of median DoR was defined as the time at which half of the responding (PR or CR) participants had progressed (PD) or died from any cause, whichever occurred first. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. PD: as defined in the description for Event-Free Survival outcome measure.	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)