Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
NCT ID: NCT00748189
Last Updated: 2019-06-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
447 participants
INTERVENTIONAL
2008-12-22
2018-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Study Groups
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ofatumumab + chlorambucil
ofatumumab dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles
chlorambucil, tablets
2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
ofatumumab (GSK1841157) infusion
iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;
chlorambucil
chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
chlorambucil, tablets
2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
Interventions
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chlorambucil, tablets
2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
ofatumumab (GSK1841157) infusion
iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* considered inappropriate for fludarabine-based therapy
* not been treated for CLL before
* fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
* age 18yrs or older
* signed written informed consent
Exclusion Criteria
* abnormal/inadequate blood values, liver, and kidney function
* certain heart problems, active or chronic infections, serious significant diseases, active autoimmune hemolytic anemia (AIHA) requiring treatment, other current cancer or within last 5 years
* CLL transformation
* CLL central nervous system involvement
* current participation in other clinical study
* inability to comply with the protocol activities
* lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Sedona, Arizona, United States
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Tucson, Arizona, United States
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Murrieta, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Boca Raton, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Ocoee, Florida, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Lee's Summit, Missouri, United States
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Raleigh, North Carolina, United States
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Abilene, Texas, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Midland, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Webster, Texas, United States
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Seattle, Washington, United States
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Vancouver, Washington, United States
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Yakima, Washington, United States
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Bruges, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Haine-Saint-Paul, , Belgium
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Leuven, , Belgium
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Porto Alegre, Rio de Janeiro, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Créteil, , France
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Pierre-Bénite, , France
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Karlsruhe, Baden-Wurttemberg, Germany
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Mannheim, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Ulm, Baden-Wurttemberg, Germany
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Erlangen, Bavaria, Germany
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Munich, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Kassel, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Lehrte, Lower Saxony, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Moenchengladbach-Rheydt, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Saarbrücken, Saarland, Germany
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Athens, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Ahmedabad, , India
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Bangalore, , India
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Mumbai, , India
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Mumbai, , India
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New Delhi, , India
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Pune, , India
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Cork, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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James Street, , Ireland
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Limerick, , Ireland
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Tullamore, , Ireland
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Waterford, , Ireland
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Bari, Apulia, Italy
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Potenza, Basilicate, Italy
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Napoli, Campania, Italy
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Albano Laziale (Roma), Lazio, Italy
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Genoa, Liguria, Italy
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Brescia, Lombardy, Italy
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Milan, Lombardy, Italy
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Milan, Lombardy, Italy
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Milan, Lombardy, Italy
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Novara, Piedmont, Italy
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Palermo, Sicily, Italy
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Ascoli Piceno, The Marches, Italy
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Venezia - Mestre, Veneto, Italy
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Vicenza, Veneto, Italy
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Udine, , Italy
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Amersfoort, , Netherlands
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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The Hague, , Netherlands
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Bialystok, , Poland
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Chorzów, , Poland
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Lodz, , Poland
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Słupsk, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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St'Petersburg, , Russia
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Barcelona, , Spain
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Barcelona, , Spain
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Hospitalet de Llobregat (Barcelona), , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Salamanca, , Spain
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Valencia, , Spain
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Luleå, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Plymouth, Devon, United Kingdom
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Taunton, Somerset, United Kingdom
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Sunderland, Tyne, United Kingdom
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Bath, , United Kingdom
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Belfast, , United Kingdom
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Birmingham, , United Kingdom
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Bournemouth, , United Kingdom
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Bradford, , United Kingdom
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Cambridge, , United Kingdom
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Canterbury, Kent, , United Kingdom
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Carshalton, , United Kingdom
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Cornwall, , United Kingdom
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Dudley, , United Kingdom
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Exeter, , United Kingdom
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Glasgow, , United Kingdom
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Leeds, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Milton Keynes, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Norwich, , United Kingdom
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Oxford, , United Kingdom
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Peterborough, , United Kingdom
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Rhyl, Denbighshire, , United Kingdom
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Salford, , United Kingdom
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Stoke-on-Trent, , United Kingdom
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Swindon, , United Kingdom
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Uxbridge, , United Kingdom
Countries
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References
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Tausch E, Beck P, Schlenk RF, Jebaraj BJ, Dolnik A, Yosifov DY, Hillmen P, Offner F, Janssens A, Babu GK, Grosicki S, Mayer J, Panagiotidis P, McKeown A, Gupta IV, Skorupa A, Pallaud C, Bullinger L, Mertens D, Dohner H, Stilgenbauer S. Prognostic and predictive role of gene mutations in chronic lymphocytic leukemia: results from the pivotal phase III study COMPLEMENT1. Haematologica. 2020 Oct 1;105(10):2440-2447. doi: 10.3324/haematol.2019.229161.
Hillmen P, Robak T, Janssens A, Babu KG, Kloczko J, Grosicki S, Doubek M, Panagiotidis P, Kimby E, Schuh A, Pettitt AR, Boyd T, Montillo M, Gupta IV, Wright O, Dixon I, Carey JL, Chang CN, Lisby S, McKeown A, Offner F; COMPLEMENT 1 Study Investigators. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet. 2015 May 9;385(9980):1873-83. doi: 10.1016/S0140-6736(15)60027-7. Epub 2015 Apr 14.
Jewell RC, Laubscher K, Lewis E, Fang L, Gafoor Z, Carey J, McKeown A, West S, Wright O, Sedoti D, Dixon I, Hottenstein CS, Chan G. Assessment of the effect of ofatumumab on cardiac repolarization. J Clin Pharmacol. 2015 Jan;55(1):114-21. doi: 10.1002/jcph.376. Epub 2014 Aug 21.
Other Identifiers
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OMB110911
Identifier Type: OTHER
Identifier Source: secondary_id
OMB110911
Identifier Type: -
Identifier Source: org_study_id
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