Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
NCT ID: NCT00333840
Last Updated: 2013-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1106 participants
INTERVENTIONAL
2000-06-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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imatinib (STI571)
In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injection for 10 days every month. Maximum study duration was 11.5 years.
imatinib mesilate
imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
interferon-alpha (INF-a)
interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day.
cytarabine (ARA-C)
cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.
IFN-a+Ara-C
In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
imatinib mesilate
imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
interferon-alpha (INF-a)
interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day.
cytarabine (ARA-C)
cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.
Interventions
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imatinib mesilate
imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.
interferon-alpha (INF-a)
interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day.
cytarabine (ARA-C)
cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have completed visit 62 of the core IRIS trial or be in follow-up
* Must be on STI571 treatment
* If on IFN treatment, must be willing to cross over to STI571 treatment
Exclusion Criteria
* Patients who are on IFN treatment and do not want to cross over to STI571 treatment
* Patients who have not consented to amendment 5
* Patients who did not complete the amendment 5 protocol
18 Years
70 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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Birmingham, Alabama, United States
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Montgomery, Alabama, United States
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Tucson, Arizona, United States
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Berkeley, California, United States
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Campbell, California, United States
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Duarte, California, United States
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La Jolla, California, United States
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Denver, Colorado, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Decatur, Illinois, United States
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Beech Grove, Indiana, United States
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Witchita, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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East Lansing, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Hackensack, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Farmington, New Mexico, United States
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Buffalo, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Spartanburg, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Salt Lake City, Utah, United States
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Milwaukee, Wisconsin, United States
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Adelaide, , Australia
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Brisbane, , Australia
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Darlinghurst, , Australia
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East Melbourne, , Australia
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Nedlands, , Australia
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Parkville, , Australia
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Prahan, , Australia
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St Leonards, , Australia
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Vienna, , Austria
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Godinne, , Belgium
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Leuven, , Belgium
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Aarhus, , Denmark
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Copenhagen, , Denmark
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Herlev, , Denmark
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Créteil, , France
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Lille, , France
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Vandœuvre-lès-Nancy, , France
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Berlin, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Marburg, , Germany
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München, , Germany
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München, , Germany
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Regensburg, , Germany
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Rostock, , Germany
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Stuttgart, , Germany
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Bari, , Italy
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Bologna, , Italy
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Florence, , Italy
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Genova, , Italy
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Milan, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Pavia, , Italy
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Pescara, , Italy
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Pisa, , Italy
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Reggio Calabria, , Italy
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Amsterdam, , Netherlands
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Rotterdam, , Netherlands
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Auckland, , New Zealand
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Oslo, , Norway
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Tromsø, , Norway
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Salamanca, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Linköping, , Sweden
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Lund, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
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Basel, , Switzerland
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Bern, , Switzerland
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Sankt Gallen, , Switzerland
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Birmingham, , United Kingdom
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Cambridge, , United Kingdom
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Cardiff, , 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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Nottingham, , United Kingdom
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Plymouth, , United Kingdom
Countries
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References
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Hochhaus A, Larson RA, Guilhot F, Radich JP, Branford S, Hughes TP, Baccarani M, Deininger MW, Cervantes F, Fujihara S, Ortmann CE, Menssen HD, Kantarjian H, O'Brien SG, Druker BJ; IRIS Investigators. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. N Engl J Med. 2017 Mar 9;376(10):917-927. doi: 10.1056/NEJMoa1609324.
Jain P, Kantarjian H, Nazha A, O'Brien S, Jabbour E, Romo CG, Pierce S, Cardenas-Turanzas M, Verstovsek S, Borthakur G, Ravandi F, Quintas-Cardama A, Cortes J. Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities. Blood. 2013 Jun 13;121(24):4867-74. doi: 10.1182/blood-2013-03-490128. Epub 2013 Apr 25.
Larson RA, Druker BJ, Guilhot F, O'Brien SG, Riviere GJ, Krahnke T, Gathmann I, Wang Y; IRIS (International Randomized Interferon vs STI571) Study Group. Imatinib pharmacokinetics and its correlation with response and safety in chronic-phase chronic myeloid leukemia: a subanalysis of the IRIS study. Blood. 2008 Apr 15;111(8):4022-8. doi: 10.1182/blood-2007-10-116475. Epub 2008 Feb 6.
Other Identifiers
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CSTI571A 0106
Identifier Type: -
Identifier Source: org_study_id