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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
  Purpose

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.


Condition Intervention Phase
Chronic Myelogenous Leukemia
 Drug: imatinib mesilate
Drug: interferon-alpha/cytosine arabinoside
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: end of trial - Jan 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1099
Study Start Date: June 2000
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STI571 Drug: imatinib mesilate
Active Comparator: IFN-a+Ara-C
interferon-alpha combined with cytarabine
 Drug: interferon-alpha/cytosine arabinoside

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 that have not consented to amendment 5
  • Patients not completing amendment 5 protocol

Additional protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333840

  Show 163 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00333840     History of Changes
Other Study ID Numbers: CSTI571A 0106
Study First Received: June 2, 2006
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
CML
STI571
imatinib
interferon
 interferon alpha
cytosine arabinoside
chronic myeloid leukemia
Philadelphia chromosome positive

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Interferon-alpha
Interferon Alfa-2a
Cytarabine
 Interferons
Imatinib
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 19, 2013