Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
NCT ID: NCT00824265
Last Updated: 2020-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
365 participants
INTERVENTIONAL
2009-03-12
2017-10-25
Brief Summary
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Detailed Description
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The objective of this study was to determine the effect of ofatumumab added to fludarabine and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded previously to therapy but later develop progressive disease and require additional therapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ofatumumab, Fludarabine, Cyclophosphamide
Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles
OFC Infusion
Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles
Fludarabine, Cyclophosphamide
Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles
FC infusion
Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles
Interventions
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OFC Infusion
Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles
FC infusion
Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles
Eligibility Criteria
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Inclusion Criteria
* at least one previous treatment for CLL and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
* 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, serious significant diseases, AIHA, other current cancers or within the last 5 years
* active or chronic infections
* use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
* 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
Rome, Lazio, Italy
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Rome, Lazio, Italy
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Genoa, Liguria, Italy
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Pavia, Lombardy, Italy
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Alessandria, Piedmont, Italy
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Novara, Piedmont, Italy
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Catania, Sicily, Italy
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Palermo, Sicily, Italy
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New Delhi, , India
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Boca Raton, Florida, United States
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Chicago, Illinois, United States
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Clinton, Maryland, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Memphis, Tennessee, United States
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Brasilia, Goiás, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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New Westminster, British Columbia, Canada
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Pune, , India
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Kitchener, Ontario, Canada
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Vadodara, , India
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Potenza, Basilicate, Italy
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Karlsruhe, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Villingen-Schwenningen, Baden-Wurttemberg, Germany
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Munich, 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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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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Dresden, Saxony, Germany
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Hamburg, , Germany
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Lübeck, , Germany
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Athens, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Bangalore, , India
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Mumbai, , India
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Mumbai, , India
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Ascoli Piceno, The Marches, Italy
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Guadalajara, Jalisco, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Mexico City, , Mexico
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Amersfoort, , 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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Krakow, , Poland
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Lodz, , Poland
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Opole, , Poland
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Szczecin, , Poland
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Słupsk, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
Iași, , Romania
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Iași, , Romania
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Kazan', , Russia
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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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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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Seville, , Spain
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Cherkasy, , Ukraine
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Dnipropetrovsk, , Ukraine
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Kharkiv, , Ukraine
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Khmelnytskyi, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Makiivka, , Ukraine
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Simferopil, , Ukraine
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Vinnitsa, , Ukraine
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Zhytomyr, , Ukraine
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Birmingham, , United Kingdom
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Bradford, , United Kingdom
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Burton-on-Trent, , United Kingdom
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Cottingham, , United Kingdom
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Dudley, , United Kingdom
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Glasgow, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Sutton, , United Kingdom
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Swindon, , United Kingdom
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Truro, , United Kingdom
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Uxbridge, , United Kingdom
Countries
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References
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Robak T, Warzocha K, Govind Babu K, Kulyaba Y, Kuliczkowski K, Abdulkadyrov K, Loscertales J, Kryachok I, Kloczko J, Rekhtman G, Homenda W, Blonski JZ, McKeown A, Chang CN, Bal V, Lisby S, Gupta IV, Grosicki S. Health-related quality of life and patient-reported outcomes of ofatumumab plus fludarabine and cyclophosphamide versus fludarabine and cyclophosphamide in the COMPLEMENT 2 trial of patients with relapsed CLL. Leuk Lymphoma. 2017 Jul;58(7):1598-1606. doi: 10.1080/10428194.2016.1253837. Epub 2016 Nov 10.
Robak T, Warzocha K, Govind Babu K, Kulyaba Y, Kuliczkowski K, Abdulkadyrov K, Loscertales J, Kryachok I, Kloczko J, Rekhtman G, Homenda W, Blonski JZ, McKeown A, Gorczyca MM, Carey JL, Chang CN, Lisby S, Gupta IV, Grosicki S. Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial. Leuk Lymphoma. 2017 May;58(5):1084-1093. doi: 10.1080/10428194.2016.1233536. Epub 2016 Oct 12.
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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110913
Identifier Type: -
Identifier Source: org_study_id
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