Myeloproliferative Neoplasms Clinical Trial

Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Summary

The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Must have signed consent for Amendment 5
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 have discontinued from the study and are in follow-up
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

Additional protocol-defined inclusion/exclusion criteria may apply

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

1106

Study ID:

NCT00333840

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 145 Locations for this study

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Novartis Investigative Site
Birmingham Alabama, 35294, United States
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Montgomery Alabama, 36106, United States
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Tucson Arizona, 85724, United States
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Berkeley California, 94704, United States
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Campbell California, 95008, United States
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Duarte California, 91010, United States
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La Jolla California, 92093, United States
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Denver Colorado, 80218, United States
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Miami Florida, 33176, United States
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Orlando Florida, 32804, United States
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Atlanta Georgia, 30342, United States
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Honolulu Hawaii, 96813, United States
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Chicago Illinois, 60611, United States
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Chicago Illinois, 60612, United States
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Chicago Illinois, 60637, United States
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Decatur Illinois, 62526, United States
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Beech Grove Indiana, 46107, United States
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Witchita Kansas, 67214, United States
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Louisville Kentucky, 40202, United States
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New Orleans Louisiana, 70112, United States
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Baltimore Maryland, 21201, United States
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Boston Massachusetts, 02115, United States
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Worcester Massachusetts, 01665, United States
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Ann Arbor Michigan, 48109, United States
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Detroit Michigan, 48202, United States
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East Lansing Michigan, 48910, United States
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Minneapolis Minnesota, 55455, United States
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St. Louis Missouri, 63110, United States
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Billings Montana, 59101, United States
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Omaha Nebraska, 68198, United States
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Hackensack New Jersey, 07601, United States
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Alburquerque New Mexico, 87109, United States
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Alburquerque New Mexico, 87131, United States
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Farmington New Mexico, 87131, United States
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Buffalo New York, 14263, United States
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New York New York, 10017, United States
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New York New York, 10021, United States
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New York New York, 10029, United States
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Syracuse New York, 13210, United States
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Chapel Hill North Carolina, 27599, United States
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Charlotte North Carolina, 28203, United States
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Durham North Carolina, 27710, United States
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Winston-Salem North Carolina, 27157, United States
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Cleveland Ohio, 44195, United States
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Columbus Ohio, 43210, United States
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Columbus Ohio, 43215, United States
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Dayton Ohio, 45429, United States
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Tulsa Oklahoma, 74136, United States
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Portland Oregon, 97239, United States
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Pittsburg Pennsylvania, 15224, United States
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Pittsburg Pennsylvania, 15232, United States
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Providence Rhode Island, 02903, United States
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Spartanburg South Carolina, 29303, United States
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Memphis Tennessee, 38119, United States
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Nashville Tennessee, 37203, United States
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Nashville Tennessee, 37205, United States
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Dallas Texas, 75235, United States
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Dallas Texas, 75246, United States
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Houston Texas, 77030, United States
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Salt Lake City Utah, 84112, United States
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Seattle Washington, 98109, United States
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Milwaukee Wisconsin, 53215, 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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South Brisbane , , Australia
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St. Leonards , , Australia
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Sydney , 2050, Australia
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Westmead , , Australia
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Wien , 1090, Austria
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Bruxelles , 1000, Belgium
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Bruxelles , 1200, Belgium
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Godinne , , Belgium
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Leuven , 3000, Belgium
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Calgary Alberta, T2N 4, Canada
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Edmonton Alberta, T6G 1, Canada
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Vancouver British Columbia, V5Z 1, Canada
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Winnipeg Manitoba, R3E 0, Canada
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Halifax Nova Scotia, B3H 2, Canada
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Hamilton Ontario, L8N 3, Canada
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London Ontario, N6A 4, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H1T 2, Canada
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Montreal Quebec, H3A 1, Canada
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Arhus , 8000, Denmark
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Copenhagen , , Denmark
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Herlev , 2730, Denmark
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Creteil , 94010, France
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Lille , 59037, France
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Lyon , 69437, France
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Marseille , 13273, France
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Nantes , 44035, France
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Paris , 75475, France
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Pessac , 33604, France
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Poitiers , , France
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Strasbourg , 67098, France
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Vandoeuvre-les-Nancy , 54511, France
Novartis Investigative Site
Berlin , 13353, Germany
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Dresden , 01307, Germany
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Dusseldorf , 40225, Germany
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Frankfurt , 60590, Germany
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Freiburg , 79106, Germany
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Hamburg , 20246, Germany
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Heidelberg , 69115, Germany
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Leipzig , 04103, Germany
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Mainz , 55101, Germany
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Mannheim , 68189, Germany
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Marburg , 35037, Germany
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Muenchen , 80804, Germany
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Munchen , 81675, Germany
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Regensburg , 93042, Germany
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Rostock , 18057, Germany
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Stuttgart , 70376, Germany
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Bari , 70124, Italy
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Bologna , 40138, Italy
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Firenze , 50134, Italy
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Genova , 16132, Italy
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Milano , 20162, Italy
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Napoli , 80131, Italy
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Orbassano , 10043, Italy
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Pavia , 27100, Italy
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Pescara , 65124, Italy
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Pisa , 56126, Italy
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Reggio Calabria , 89123, Italy
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Amsterdam , 1081H, Netherlands
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Rotterdam , , Netherlands
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Auckland , , New Zealand
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Oslo , 27, Norway
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Tromso , 9038, Norway
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Barcelona , 8025, Spain
Novartis Investigative Site
Barcelona , 8036, Spain
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Barcelona , 8907, Spain
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Madrid , 28034, Spain
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Madrid , 28222, Spain
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Madrid , 46010, Spain
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Salamanca , 37007, Spain
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Valencia , 46010, Spain
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Goteborg , 143 4, Sweden
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Linkoping , 581 8, Sweden
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Lund , 221 8, Sweden
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Orebro , 70 18, Sweden
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Stockholm , 141 8, Sweden
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Stockholm , 171 7, Sweden
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Umea , 901 8, Sweden
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Uppsala , 751 8, Sweden
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Basel , 4031, Switzerland
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Bern , 3010, Switzerland
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St. Gallen , 9007, Switzerland
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Birmingham , B9 5S, United Kingdom
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Cambridge , CB2 2, United Kingdom
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Cardiff , CF14 , United Kingdom
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Leeds , LS1 3, United Kingdom
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Liverpool , L7 8X, United Kingdom
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London , EC1A , United Kingdom
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London , SE5 9, United Kingdom
Novartis Investigative Site
Manchester , M13 9, United Kingdom
Novartis Investigative Site
Nottingham , NG5 1, United Kingdom
Novartis Investigative Site
Plymouth , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

1106

Study ID:

NCT00333840

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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