Chronic Lymphocytic Leukemia Clinical Trial
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)
Summary
This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated leukemia-cll/" >chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.
Full Description
Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points.
BO21004 (Stage 1a) [NCT01010061] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to chlorambucil (Clb) reported here.
BO21004 (Stage 1b) [NCT01998880] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (RClb) compared to chlorambucil (Clb) reported separately.
BO21004 (Stage 2) [NCT02053610] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported separately.
Eligibility Criteria
Inclusion Criteria:
Adults >/=18 years
Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance < 70 ml/min
Exclusion Criteria:
Prior CLL therapy
Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
History of other malignancy unless the malignancy has been in remission without treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy alone
Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus (HTLV) testing
Patients with active infection requiring systemic treatment
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There are 259 Locations for this study
San Diego California, 92123, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21215, United States
Green Bay Wisconsin, 54311, United States
Waukesha Wisconsin, 53188, United States
Buenos Aires , 1406, Argentina
Buenos Aires , 1425, Argentina
Buenos Aires , C1114, Argentina
Buenos Aires , C1180, Argentina
Buenos Aires , C1221, Argentina
Buenos Aires , C1431, Argentina
Rosario , 2000, Argentina
Adelaide New South Wales, 5011, Australia
Gosford New South Wales, 2250, Australia
Kogarah New South Wales, 2217, Australia
Liverpool New South Wales, 2170, Australia
St. Leonards New South Wales, 2065, Australia
Sydney New South Wales, 2139, Australia
Greenslopes Queensland, 4120, Australia
Southport Queensland, 4215, Australia
Woolloongabba Queensland, 4102, Australia
Kurralta Park South Australia, 5037, Australia
Frankston Victoria, 3199, Australia
Melbourne Victoria, 3168, Australia
Graz , 8036, Austria
Innsbruck , 6020, Austria
Wien , 1090, Austria
Wien , 1160, Austria
Goiania GO, 74140, Brazil
Belo Horizonte MG, 31270, Brazil
Porto Alegre RS, 90880, Brazil
Santo Andre SP, 09060, Brazil
Sao Paulo SP, 05403, Brazil
Pleven , 5800, Bulgaria
Plovdiv , 4002, Bulgaria
Sofia , 1756, Bulgaria
Varna , 9010, Bulgaria
Vratsa , 3000, Bulgaria
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Winnipeg Manitoba, R0C 2, Canada
Halifax Nova Scotia, B3H 2, Canada
Barrie Ontario, L4M 6, Canada
Ottawa Ontario, K1H 8, Canada
Montreal Quebec, H2L 4, Canada
Rimouski Quebec, G5L 5, Canada
Zagreb , 10000, Croatia
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Praha 2 , 128 0, Czechia
Aalborg , 9000, Denmark
København , 2100, Denmark
Odense , 5000, Denmark
Vejle , 7100, Denmark
Ã…rhus , 8000, Denmark
Cairo , 11796, Egypt
Tallinn , 13419, Estonia
Tartu , 51014, Estonia
Angers , 49933, France
Bobigny , 93009, France
Caen , 14076, France
Clermont Ferrand , 63003, France
Creteil , 94010, France
Le Mans , 72015, France
Lille , 59037, France
Lyon , 69373, France
Marseille , 13273, France
Montpellier , 34295, France
Nantes , 44093, France
Paris , 75475, France
Paris , 75651, France
Pessac , 33604, France
Pierre Benite , 69495, France
Poitiers , 86021, France
Reims , 51092, France
Rennes , 35033, France
Rouen , 76038, France
Toulouse , 31059, France
Tours , 37044, France
Vandoeuvre Les Nancy , 54511, France
Ahaus , 48683, Germany
Amberg , 92224, Germany
Ansbach , 91522, Germany
Bamberg , 96049, Germany
Berlin , 12200, Germany
Bonn , 53113, Germany
Bremen , 28177, Germany
Bremen , 28209, Germany
Bremen , 28239, Germany
Delitzsch , 04509, Germany
Detmold , 32756, Germany
Dresden , 01127, Germany
Dresden , 01307, Germany
Duisburg , 47051, Germany
Erlangen , 91052, Germany
Erlangen , 91054, Germany
Eschweiler , 52249, Germany
Essen , 45122, Germany
Essen , 45239, Germany
Esslingen , 73730, Germany
Frankfurt am Main , 60389, Germany
Frankfurt an der Oder , 15236, Germany
Frankfurt , 60596, Germany
Frechen , 50226, Germany
Freiburg , 79106, Germany
Giessen , , Germany
Greifswald , 17475, Germany
Göttingen , 37075, Germany
Hamburg , 20095, Germany
Hamburg , 20099, Germany
Hamburg , 20246, Germany
Hamburg , 22081, Germany
Hamburg , 22087, Germany
Hamburg , 22767, Germany
Hamm , 59063, Germany
Hannover , 30449, Germany
Heidelberg , 69120, Germany
Homburg/Saar , 66241, Germany
Kaiserslautern , 67655, Germany
Karlsruhe , 76133, Germany
Kempten , 87439, Germany
Kiel , 24116, Germany
Koblenz , 56068, Germany
Koeln , 50674, Germany
Kronach , 96317, Germany
Köln , 50924, Germany
Landshut , 84028, Germany
Lebach , 66822, Germany
Leer , 26789, Germany
Lemgo , 32657, Germany
Lörrach , 79539, Germany
Lüdenscheid , 58515, Germany
Magedburg , 39104, Germany
Mainz , 55131, Germany
Mannheim , 68161, Germany
Muenchen , 81377, Germany
Mutlangen , 73557, Germany
München , 80335, Germany
München , 81241, Germany
München , 81479, Germany
München , 81675, Germany
Neunkirchen/Saar , 66538, Germany
Nürnberg , 90449, Germany
Oldenburg , 26121, Germany
Porta Westfalica , 32457, Germany
Ravensburg , 88212, Germany
Recklinghausen , 45657, Germany
Regensburg , 93049, Germany
Regensburg , 93053, Germany
Rostock , 18057, Germany
Rüsselsheim , 65428, Germany
Saarbruecken , 66113, Germany
Sindelfingen , 71065, Germany
Stuttgart , 70199, Germany
Trier , 54290, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Villingen-Schwenningen , 78052, Germany
Weilheim , 82362, Germany
Wendlingen , 73240, Germany
Witten , 58452, Germany
Worms , 67547, Germany
Wuerzburg , 97080, Germany
Würzburg , 97080, Germany
Hong Kong , , Hong Kong
Cagliari , 09121, Italy
Cosenza , 87100, Italy
Ferrara , 44100, Italy
Genova , 16132, Italy
Messina , 98165, Italy
Milano , 20132, Italy
Milano , 20162, Italy
Modena , 41100, Italy
Orbassano , 10043, Italy
Roma , 00144, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Terni , 05100, Italy
Torino , 10126, Italy
Aguascalientes , 20127, Mexico
Culiacan , 80230, Mexico
Hermosillo , 83000, Mexico
Monterrey , 64460, Mexico
San Luis Potosi , 78218, Mexico
Delftzijl , 9934 , Netherlands
Enschede , 7511 , Netherlands
Leeuwarden , 8934 , Netherlands
Nieuwegein , 3430 , Netherlands
Auckland , 1009, New Zealand
Christchurch , 8011, New Zealand
Bucharest , 02232, Romania
Bucuresti , 03017, Romania
Targu-mures , 54013, Romania
Kazan , 42002, Russian Federation
Nizhny Novgorod , 60312, Russian Federation
Penza , 44007, Russian Federation
Perm , 61407, Russian Federation
Rostov-na-donu , 34402, Russian Federation
UFA , 45000, Russian Federation
Bratislava , 833 1, Slovakia
Oviedo Asturias, 33006, Spain
Manresa Barcelona, 08240, Spain
Sabadell Barcelona, 08208, Spain
Jerez de La Frontera Cadiz, 11407, Spain
Santander Cantabria, 39008, Spain
San Sebastian Guipuzcoa, 20014, Spain
La Coruna LA Coruña, 15006, Spain
Santiago de Compostela LA Coruña, 15706, Spain
Pamplona Navarra, 31008, Spain
La Laguna Tenerife, 38320, Spain
Gandia Valencia, 46702, Spain
Barcelona , 08003, Spain
Barcelona , 08025, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Jaen , 23007, Spain
Las Palmas , 35020, Spain
Madrid , 28006, Spain
Madrid , 28031, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28222, Spain
Madrid , 28905, Spain
Malaga , 29010, Spain
Malaga , 29600, Spain
Murcia , 30008, Spain
Murcia , 30120, Spain
Salamanca , 37007, Spain
Sevilla , 41014, Spain
Toledo , 45004, Spain
Toledo , 45600, Spain
Valencia , 46009, Spain
Valencia , 46010, Spain
Valencia , 46014, Spain
Valencia , 46015, Spain
Valencia , 46017, Spain
Zaragoza , 50009, Spain
Aarau , 5001, Switzerland
Basel , 4031, Switzerland
Bern , 3010, Switzerland
Chur , 7000, Switzerland
Luzern , 6000, Switzerland
St. Gallen , 9007, Switzerland
Zürich , 8091, Switzerland
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Khon Kaen , 40002, Thailand
Bournemouth , BH7 7, United Kingdom
Cambridge , CB2 0, United Kingdom
Canterbury , CT1 3, United Kingdom
Cardiff , CF14 , United Kingdom
Cottingham , HU16 , United Kingdom
Edinburgh , EH4 2, United Kingdom
Glasgow , G12 0, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC1M , United Kingdom
London , NW3 2, United Kingdom
Nottingham , NG5 1, United Kingdom
Sutton , SM2 5, United Kingdom
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