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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
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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)
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Secondary ID [1]
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0
CSTI571A 0106
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Myelogenous Leukemia
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0
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Condition category
Condition code
Cancer
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Human Genetics and Inherited Disorders
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0
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Kaplan-Meier Estimates of Overall Survival (All Randomized Participants)
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Assessment method [1]
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Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
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Timepoint [1]
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12,24,36,48,60,72,84,96,108,120,132 and 144 months
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Secondary outcome [1]
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Kaplan Meier Estimates of Event Free Survival (All Randomized Participants)
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Assessment method [1]
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Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:
* progression to Accelerated Phase (AP) or Blast Crisis (BC)
* loss of Complete Hematological Response (CHR)
* loss of Major Cytogenetic Response (MCyR) confirmed
* loss of Major Cytogenetic Response (MCyR) unconfirmed
* increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)
* death (due to any cause when reported as primary reason for discontinuation of treatment).
Kaplan Meier estimates of the percentage of participants with Event Free Survival at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
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Timepoint [1]
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12,24,36,48,60,72,84,96,108,120,132 and 144 months
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Secondary outcome [2]
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Percentage of Participants With Event Free Survival Events (All Randomized Participants)
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Assessment method [2]
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Event-free survival is defined as the time between randomization and the earliest of any of the following events on treatment:
* progression to Accelerated Phase (AP) or Blast Crisis (BC)
* loss of Complete Hematological Response (CHR)
* loss of Major Cytogenic Response (MCyR) confirmed
* loss of Major Cytogenic Response (MCyR) unconfirmed
* increase in white blood cell count (WBC) if approved by the Study Management Committee (SMC)
* death (due to any cause when reported as primary reason for discontinuation of treatment).
The percentage of participants with Event Free Survival events in each category was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
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Timepoint [2]
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144 months
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Secondary outcome [3]
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Kaplan Meier Estimates of Time to Progression to Accelerated Phase (AP) or Blast Crisis (BC) (All Randomized Participants)
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Assessment method [3]
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Time to progression to AP/BC is defined as the time between randomization and either of the following events on treatment: death (due to CML when reported as primary reason for discontinuation of treatment) or progression to Accelerated Phase or Blast Crisis and is censored at last examination date for patients without event. No data after discontinuation of study treatment was included. The Kaplan Meier estimates of the percentage of participants with survival without progression to AP/BC at the given time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed over, were attributed following crossover to the original randomized treatment.
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Timepoint [3]
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12,24,36,48,60,72,84,96,108,120,132 and 144 months
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Secondary outcome [4]
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Percentage of Participants With Best Cytogenetic Response (First-line Treatment)
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Assessment method [4]
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Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Philadelphia chromosome positive (Ph+) metaphases) and amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.
Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= \> 0 and = 35 % of Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated.
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Timepoint [4]
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144 months
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Secondary outcome [5]
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Percentage of Participants With Best Cytogenetic Response (Second-line Treatment)
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Assessment method [5]
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Bone marrow aspirate was performed to evaluate cytogenetic results (percentage of Ph chromosome (Ph+) containing metaphases) and the amount of blasts and promyelocytes in bone marrow to establish cytogenetic response.
Major Cytogenetic Response= Complete Response or Partial Response. Complete Cytogenetic Response= 0 % of Ph+ metaphases (out of 20 metaphases). Partial Cytogenetic Response= \> 0 and = 35 % Ph+ metaphases (out of 20 metaphases). The percentage of participants with cytogenetic response in each category was calculated.
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Timepoint [5]
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144 months
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Secondary outcome [6]
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Number of Participants With Serious Adverse Events as a Measure of Safety (First-line Treatment)
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Assessment method [6]
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A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant
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Timepoint [6]
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0
144 months
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Secondary outcome [7]
0
0
Number of Participants With Serious Adverse Events as a Measure of Safety (Second-line Treatment)
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Assessment method [7]
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0
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant
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Timepoint [7]
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144 months
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Secondary outcome [8]
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Percentage of Participants With Major Molecular Response (First-line Treatment)
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Assessment method [8]
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Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of = 0.1% according to the international scale.
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Timepoint [8]
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12,24,36,48,60,72,84,96,108,120,132 and 144 months
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Secondary outcome [9]
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Percentage of Participants With Major Molecular Response (Second-line Treatment)
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Assessment method [9]
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Major Molecular Response was determined using a quantitative polymerase chain reaction (PCR) laboratory test and was defined as BCR-ABL protein transcripts of = 0.1% according to the international scale.
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Timepoint [9]
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12,24,36,48,60,72,84,96,108,120,132 and 144 months
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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
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Minimum age
18
Years
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2012
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Sample size
Target
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Accrual to date
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Final
1106
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - Adelaide
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Novartis Investigative Site - Brisbane
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Novartis Investigative Site - Darlinghurst
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Novartis Investigative Site - East Melbourne
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Novartis Investigative Site - Nedlands
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Recruitment hospital [6]
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Novartis Investigative Site - Parkville
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Recruitment hospital [7]
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Novartis Investigative Site - Prahan
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Novartis Investigative Site - South Brisbane
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Novartis Investigative Site - St. Leonards
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Recruitment hospital [10]
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Novartis Investigative Site - Sydney
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Recruitment hospital [11]
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Novartis Investigative Site - Westmead
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Recruitment postcode(s) [1]
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- 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
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- St. Leonards
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Recruitment postcode(s) [10]
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2050 - Sydney
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Recruitment postcode(s) [11]
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- Westmead
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Recruitment outside Australia
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Pisa
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Plymouth
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Funding & Sponsors
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Name
Novartis Pharmaceuticals
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00333840
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Trial related presentations / publications
Hochhaus A, Larson RA, Guilhot F, Radich JP, Branford S, Hughes TP, Baccarani M, Deininger MW, Cervantes F, Fujihara S, Ortmann CE, Menssen HD, Kantarjian H, O'Brien SG, Druker BJ; IRIS Investigators. Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid Leukemia. N Engl J Med. 2017 Mar 9;376(10):917-927. doi: 10.1056/NEJMoa1609324. Jain P, Kantarjian H, Nazha A, O'Brien S, Jabbour E, Romo CG, Pierce S, Cardenas-Turanzas M, Verstovsek S, Borthakur G, Ravandi F, Quintas-Cardama A, Cortes J. Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities. Blood. 2013 Jun 13;121(24):4867-74. doi: 10.1182/blood-2013-03-490128. Epub 2013 Apr 25. 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. doi: 10.1182/blood-2007-10-116475. Epub 2008 Feb 6.
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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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
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Results are available at
https://clinicaltrials.gov/study/NCT00333840
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