CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)
NCT ID: NCT01010061
Last Updated: 2018-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
787 participants
INTERVENTIONAL
2009-12-21
2017-08-23
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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obinutuzumab + chlorambucil (GClb)
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
obinutuzumab
1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).
chlorambucil
Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.
rituximab + chlorambucil (RClb)
Participants received 375 mg/m\^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
rituximab
375 mg/m\^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6.
chlorambucil
Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.
Chlorambucil (Clb)
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
chlorambucil
Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.
Interventions
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obinutuzumab
1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).
rituximab
375 mg/m\^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6.
chlorambucil
Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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German CLL Study Group
OTHER
Genentech, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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San Diego, California, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Green Bay, Wisconsin, United States
Waukesha, Wisconsin, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Rosario, , Argentina
Adelaide, New South Wales, Australia
Gosford, New South Wales, Australia
Kogarah, New South Wales, Australia
Liverpool, New South Wales, Australia
St Leonards, New South Wales, Australia
Sydney, New South Wales, Australia
Greenslopes, Queensland, Australia
Southport, Queensland, Australia
Woolloongabba, Queensland, Australia
Kurralta Park, South Australia, Australia
Frankston, Victoria, Australia
Melbourne, Victoria, Australia
Graz, , Austria
Innsbruck, , Austria
Vienna, , Austria
Vienna, , Austria
Goiânia, Goiás, Brazil
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Santo André, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Vratsa, , Bulgaria
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
Barrie, Ontario, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Rimouski, Quebec, Canada
Zagreb, , Croatia
Brno, , Czechia
Hradec Králové, , Czechia
Prague, , Czechia
Aalborg, , Denmark
Aarhus, , Denmark
Copenhagen, , Denmark
Odense, , Denmark
Vejle, , Denmark
Cairo, , Egypt
Tallinn, , Estonia
Tartu, , Estonia
Angers, , France
Bobigny, , France
Caen, , France
Clermont-Ferrand, , France
Créteil, , France
Le Mans, , France
Lille, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Nantes, , France
Paris, , France
Paris, , France
Pessac, , France
Pierre-Bénite, , France
Poitiers, , France
Reims, , France
Rennes, , France
Rouen, , France
Toulouse, , France
Tours, , France
Vandœuvre-lès-Nancy, , France
Ahaus, , Germany
Amberg, , Germany
Ansbach, , Germany
Bamberg, , Germany
Berlin, , Germany
Bonn, , Germany
Bremen, , Germany
Bremen, , Germany
Bremen, , Germany
Cologne, , Germany
Cologne, , Germany
Delitzsch, , Germany
Detmold, , Germany
Dresden, , Germany
Dresden, , Germany
Duisburg, , Germany
Erlangen, , Germany
Erlangen, , Germany
Eschweiler, , Germany
Essen, , Germany
Essen, , Germany
Esslingen am Neckar, , Germany
Frankfurt, , Germany
Frankfurt (Oder), , Germany
Frankfurt am Main, , Germany
Frechen, , Germany
Freiburg im Breisgau, , Germany
Giessen, , Germany
Göttingen, , Germany
Greifswald, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamm, , Germany
Hanover, , Germany
Heidelberg, , Germany
Homburg/Saar, , Germany
Kaiserslautern, , Germany
Karlsruhe, , Germany
Kempten, , Germany
Kiel, , Germany
Koblenz, , Germany
Kronach, , Germany
Landshut, , Germany
Lebach, , Germany
Leer, , Germany
Lemgo, , Germany
Loerrach, , Germany
Lüdenscheid, , Germany
Magedburg, , Germany
Mainz, , Germany
Mannheim, , Germany
Mutlangen, , Germany
München, , Germany
München, , Germany
München, , Germany
München, , Germany
München, , Germany
Neunkirchen/Saar, , Germany
Nuremberg, , Germany
Oldenburg, , Germany
Porta Westfalica, , Germany
Ravensburg, , Germany
Recklinghausen, , Germany
Regensburg, , Germany
Regensburg, , Germany
Rostock, , Germany
Rüsselsheim am Main, , Germany
Saarbrücken, , Germany
Sindelfingen, , Germany
Stuttgart, , Germany
Trier, , Germany
Tübingen, , Germany
Ulm, , Germany
Villingen-Schwenningen, , Germany
Weilheim, , Germany
Wendlingen, , Germany
Witten, , Germany
Worms, , Germany
Würzburg, , Germany
Hong Kong, , Hong Kong
Cagliari, , Italy
Cosenza, , Italy
Ferrara, , Italy
Genova, , Italy
Messina, , Italy
Milan, , Italy
Milan, , Italy
Modena, , Italy
Orbassano, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Terni, , Italy
Torino, , Italy
Aguascalientes, , Mexico
Culiacán, , Mexico
Hermosillo, , Mexico
Monterrey, , Mexico
San Luis Potosí City, , Mexico
Delftzijl, , Netherlands
Enschede, , Netherlands
Leeuwarden, , Netherlands
Nieuwegein, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Bucharest, , Romania
Bucharest, , Romania
Târgu Mureş, , Romania
Kazan', , Russia
Nizhny Novgorod, , Russia
Penza, , Russia
Perm, , Russia
Rostov-on-Don, , Russia
Ufa, , Russia
Bratislava, , Slovakia
Manresa, Barcelona, Spain
Sabadell, Barcelona, Spain
Jerez de la Frontera, Cadiz, Spain
Santander, Cantabria, Spain
Donostia / San Sebastian, Guipuzcoa, Spain
A Coruña, LA Coruña, Spain
Santiago de Compostela, LA Coruña, Spain
Pamplona, Navarre, Spain
Oviedo, Principality of Asturias, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Gandia, Valencia, Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Jaén, , Spain
Las Palmas, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Málaga, , Spain
Murcia, , Spain
Murcia, , Spain
Salamanca, , Spain
Seville, , Spain
Toledo, , Spain
Toledo, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Valencia, , Spain
Zaragoza, , Spain
Aarau, , Switzerland
Basel, , Switzerland
Bern, , Switzerland
Chur, , Switzerland
Lucerne, , Switzerland
Sankt Gallen, , Switzerland
Zurich, , Switzerland
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Khon Kaen, , Thailand
Bournemouth, , United Kingdom
Cambridge, , United Kingdom
Canterbury, , United Kingdom
Cardiff, , United Kingdom
Cottingham, , United Kingdom
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
Leicester, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Sutton, , United Kingdom
Countries
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References
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Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.
Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.
Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.
Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, Chagorova T, de la Serna J, Dilhuydy MS, Illmer T, Opat S, Owen CJ, Samoylova O, Kreuzer KA, Stilgenbauer S, Dohner H, Langerak AW, Ritgen M, Kneba M, Asikanius E, Humphrey K, Wenger M, Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8.
Other Identifiers
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2009-012476-28; CLL11
Identifier Type: -
Identifier Source: secondary_id
BO21004 (Stage 1a)
Identifier Type: -
Identifier Source: org_study_id
NCT02035462
Identifier Type: -
Identifier Source: nct_alias
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