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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00333840
First received: June 2, 2006
Last updated: December 6, 2012
Last verified: December 2012
History of Changes

June 2, 2006
December 6, 2012
June 2000
March 2012   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: end of trial - Jan 2012 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00333840 on ClinicalTrials.gov Archive Site
  • Event free survival [ Time Frame: at end of trial ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: at end of study ] [ Designated as safety issue: No ]
  • Survival without progression to AP/BC [ Time Frame: at end of trial ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
A Phase III Study of STI571 Versus Interferon-α (IFN-α) Combined With Cytarabine (Ara-C) in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myelogenous Leukemia
  • Drug: imatinib mesilate
  • Drug: interferon-alpha/cytosine arabinoside
  • Experimental: STI571
    Intervention: Drug: imatinib mesilate
  • Active Comparator: IFN-a+Ara-C
    interferon-alpha combined with cytarabine
    Intervention: Drug: interferon-alpha/cytosine arabinoside
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. Epub 2008 Feb 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1099
March 2012
March 2012   (final data collection date for primary outcome measure)

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 that have not consented to amendment 5
  • Patients not completing amendment 5 protocol

Additional protocol-defined inclusion/exclusion criteria may apply
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   New Zealand,   Norway,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00333840
CSTI571A 0106
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP