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:
Novartis Pharmaceuticals
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
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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:
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
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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