Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- East Melbourne
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Prahan
Recruitment postcode(s) [8] 0 0
- 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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
Rhode Island
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Austria
State/province [35] 0 0
Wien
Country [36] 0 0
Belgium
State/province [36] 0 0
Bruxelles
Country [37] 0 0
Belgium
State/province [37] 0 0
Godinne
Country [38] 0 0
Belgium
State/province [38] 0 0
Leuven
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
British Columbia
Country [41] 0 0
Canada
State/province [41] 0 0
Manitoba
Country [42] 0 0
Canada
State/province [42] 0 0
Nova Scotia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Denmark
State/province [45] 0 0
Arhus
Country [46] 0 0
Denmark
State/province [46] 0 0
Copenhagen
Country [47] 0 0
Denmark
State/province [47] 0 0
Herlev
Country [48] 0 0
France
State/province [48] 0 0
Creteil
Country [49] 0 0
France
State/province [49] 0 0
Lille
Country [50] 0 0
France
State/province [50] 0 0
Lyon
Country [51] 0 0
France
State/province [51] 0 0
Marseille
Country [52] 0 0
France
State/province [52] 0 0
Nantes
Country [53] 0 0
France
State/province [53] 0 0
Paris
Country [54] 0 0
France
State/province [54] 0 0
Pessac
Country [55] 0 0
France
State/province [55] 0 0
Poitiers
Country [56] 0 0
France
State/province [56] 0 0
Strasbourg
Country [57] 0 0
France
State/province [57] 0 0
Vandoeuvre-les-Nancy
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Dresden
Country [60] 0 0
Germany
State/province [60] 0 0
Dusseldorf
Country [61] 0 0
Germany
State/province [61] 0 0
Frankfurt
Country [62] 0 0
Germany
State/province [62] 0 0
Freiburg
Country [63] 0 0
Germany
State/province [63] 0 0
Hamburg
Country [64] 0 0
Germany
State/province [64] 0 0
Heidelberg
Country [65] 0 0
Germany
State/province [65] 0 0
Leipzig
Country [66] 0 0
Germany
State/province [66] 0 0
Mainz
Country [67] 0 0
Germany
State/province [67] 0 0
Mannheim
Country [68] 0 0
Germany
State/province [68] 0 0
Marburg
Country [69] 0 0
Germany
State/province [69] 0 0
Muenchen
Country [70] 0 0
Germany
State/province [70] 0 0
Munchen
Country [71] 0 0
Germany
State/province [71] 0 0
Regensburg
Country [72] 0 0
Germany
State/province [72] 0 0
Rostock
Country [73] 0 0
Germany
State/province [73] 0 0
Stuttgart
Country [74] 0 0
Italy
State/province [74] 0 0
Bari
Country [75] 0 0
Italy
State/province [75] 0 0
Bologna
Country [76] 0 0
Italy
State/province [76] 0 0
Firenze
Country [77] 0 0
Italy
State/province [77] 0 0
Genova
Country [78] 0 0
Italy
State/province [78] 0 0
Milano
Country [79] 0 0
Italy
State/province [79] 0 0
Napoli
Country [80] 0 0
Italy
State/province [80] 0 0
Orbassano
Country [81] 0 0
Italy
State/province [81] 0 0
Pavia
Country [82] 0 0
Italy
State/province [82] 0 0
Pescara
Country [83] 0 0
Italy
State/province [83] 0 0
Pisa
Country [84] 0 0
Italy
State/province [84] 0 0
Reggio Calabria
Country [85] 0 0
Netherlands
State/province [85] 0 0
Amsterdam
Country [86] 0 0
Netherlands
State/province [86] 0 0
Rotterdam
Country [87] 0 0
New Zealand
State/province [87] 0 0
Auckland
Country [88] 0 0
Norway
State/province [88] 0 0
Oslo
Country [89] 0 0
Norway
State/province [89] 0 0
Tromso
Country [90] 0 0
Spain
State/province [90] 0 0
Barcelona
Country [91] 0 0
Spain
State/province [91] 0 0
Madrid
Country [92] 0 0
Spain
State/province [92] 0 0
Salamanca
Country [93] 0 0
Spain
State/province [93] 0 0
Valencia
Country [94] 0 0
Sweden
State/province [94] 0 0
Goteborg
Country [95] 0 0
Sweden
State/province [95] 0 0
Linkoping
Country [96] 0 0
Sweden
State/province [96] 0 0
Lund
Country [97] 0 0
Sweden
State/province [97] 0 0
Orebro
Country [98] 0 0
Sweden
State/province [98] 0 0
Stockholm
Country [99] 0 0
Sweden
State/province [99] 0 0
Umea
Country [100] 0 0
Sweden
State/province [100] 0 0
Uppsala
Country [101] 0 0
Switzerland
State/province [101] 0 0
Basel
Country [102] 0 0
Switzerland
State/province [102] 0 0
Bern
Country [103] 0 0
Switzerland
State/province [103] 0 0
St. Gallen
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Birmingham
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Cambridge
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Cardiff
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Leeds
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Liverpool
Country [109] 0 0
United Kingdom
State/province [109] 0 0
London
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Manchester
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Nottingham
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00333840
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