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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00333840




Registration number
NCT00333840
Ethics application status
Date submitted
2/06/2006
Date registered
6/06/2006
Date last updated
14/10/2013

Titles & IDs
Public title
Safety and Efficacy of Imatinib Versus Interferon-a Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Scientific title
A Phase III Study of STI571 Versus Interferon-a (IFN-a) Combined With Cytarabine (Ara-C) in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Secondary ID [1] 0 0
CSTI571A 0106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myelogenous Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - imatinib mesilate
Treatment: Drugs - interferon-alpha (INF-a)
Treatment: Drugs - cytarabine (ARA-C)

Experimental: 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.

Active comparator: 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.


Treatment: Drugs: imatinib mesilate
imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.

Treatment: Drugs: 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.

Treatment: Drugs: cytarabine (ARA-C)
cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier Estimates of Overall Survival (All Randomized Participants)
Timepoint [1] 0 0
12,24,36,48,60,72,84,96,108,120,132 and 144 months
Secondary outcome [1] 0 0
Kaplan Meier Estimates of Event Free Survival (All Randomized Participants)
Timepoint [1] 0 0
12,24,36,48,60,72,84,96,108,120,132 and 144 months
Secondary outcome [2] 0 0
Percentage of Participants With Event Free Survival Events (All Randomized Participants)
Timepoint [2] 0 0
144 months
Secondary outcome [3] 0 0
Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants)
Timepoint [3] 0 0
12,24,36,48,60,72,84,96,108,120,132 and 144 months
Secondary outcome [4] 0 0
Percentage of Participants With Best Cytogenetic Response (First-line Treatment)
Timepoint [4] 0 0
144 months
Secondary outcome [5] 0 0
Percentage of Participants With Best Cytogenetic Response (Second-line Treatment)
Timepoint [5] 0 0
144 months
Secondary outcome [6] 0 0
Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment)
Timepoint [6] 0 0
144 months
Secondary outcome [7] 0 0
Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment)
Timepoint [7] 0 0
144 months
Secondary outcome [8] 0 0
Percentage of Participants With Major Molecular Response (First-line Treatment)
Timepoint [8] 0 0
12,24,36,48,60,72,84,96,108,120,132 and 144 months
Secondary outcome [9] 0 0
Percentage of Participants With Major Molecular Response (Second-line Treatment)
Timepoint [9] 0 0
12,24,36,48,60,72,84,96,108,120,132 and 144 months

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
1106
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - Brisbane
Recruitment hospital [3] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [4] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [5] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [6] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [7] 0 0
Novartis Investigative Site - Prahan
Recruitment hospital [8] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [9] 0 0
Novartis Investigative Site - St. Leonards
Recruitment hospital [10] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [11] 0 0
Novartis Investigative Site - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Brisbane
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- Darlinghurst
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- East Melbourne
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- Nedlands
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- Parkville
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- Prahan
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- South Brisbane
Recruitment postcode(s) [9] 0 0
- St. Leonards
Recruitment postcode(s) [10] 0 0
2050 - Sydney
Recruitment postcode(s) [11] 0 0
- Westmead
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00333840