Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00760877
Registration number
NCT00760877
Ethics application status
Date submitted
25/09/2008
Date registered
26/09/2008
Date last updated
8/11/2016
Titles & IDs
Public title
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)
Query!
Scientific title
An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.
Query!
Secondary ID [1]
0
0
2009-012616-40
Query!
Secondary ID [2]
0
0
CAMN107A2405
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
CHRONIC MYELOGENOUS LEUKEMIA
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Nilotinib
Treatment: Drugs - Imatinib
Experimental: Nilotinib - Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Active Comparator: Imatinib - Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Treatment: Drugs: Nilotinib
Supplied in 200 mg capsules
Treatment: Drugs: Imatinib
Supplied in 100 mg and 400 mg capsules
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)
Query!
Assessment method [1]
0
0
The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) = 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.
Query!
Timepoint [1]
0
0
12 months
Query!
Secondary outcome [1]
0
0
Rate of Confirmed Best Cumulative CMR
Query!
Assessment method [1]
0
0
The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the 24, 36 and 48 months post treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) = 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.
Query!
Timepoint [1]
0
0
24 months, 36 month, 48 months
Query!
Secondary outcome [2]
0
0
Number of Cross-over Participants With CMR
Query!
Assessment method [2]
0
0
The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) = 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.
Query!
Timepoint [2]
0
0
24 months, 36 months, 48 months
Query!
Secondary outcome [3]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [3]
0
0
PFS was defined as the time from the date of randomization to the date of the earliest documented progression-defining event as follows: transformation to blast crisis or accelerated phase disease, or death from any cause.
Query!
Timepoint [3]
0
0
48 months
Query!
Secondary outcome [4]
0
0
Event-free Survival
Query!
Assessment method [4]
0
0
Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.
Query!
Timepoint [4]
0
0
48 months
Query!
Secondary outcome [5]
0
0
Overall Survival
Query!
Assessment method [5]
0
0
Overall survival was defined as the time from the date of randomization to the date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.
Query!
Timepoint [5]
0
0
48 months
Query!
Eligibility
Key inclusion criteria
Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR
Documented CCyR by bone marrow or BCR-ABL<1% IS in the past 12 months Persistent disease
demonstrated by two PCR positive tests 3 months apart both during the past 6 months.
Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose No
other current or planned anti-leukemia therapies
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months)
Patient has received another investigational agent within last 6 months or tyrosine kinase
inhibitors (TKIs) other than imatinib Prior allogeneic stem cell transplantation
Impaired cardiac function including any one of the following:
Inability to monitor the QT interval on electrocardiogram (ECG) Long QT syndrome or a known
family history of long QT syndrome. Clinically significant resting brachycardia (<50 beats
per minute) QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and
electrolytes are not within normal ranges, electrolytes should be corrected and then the
patient re-screened for QTc Myocardial infarction within 12 months prior to starting study
Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive
heart failure or uncontrolled hypertension) History of or presence of clinically
significant ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g.
G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
207
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - St. Leonards
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Westmead
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Herston
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - South Brisbane
Query!
Recruitment hospital [5]
0
0
Novartis Investigative Site - Woolloongabba
Query!
Recruitment hospital [6]
0
0
Novartis Investigative Site - Adelaide
Query!
Recruitment hospital [7]
0
0
Novartis Investigative Site - Parkville
Query!
Recruitment hospital [8]
0
0
Novartis Investigative Site - Prahran
Query!
Recruitment hospital [9]
0
0
Novartis Investigative Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2065 - St. Leonards
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [6]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [7]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [8]
0
0
3181 - Prahran
Query!
Recruitment postcode(s) [9]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Brazil
Query!
State/province [2]
0
0
MG
Query!
Country [3]
0
0
Brazil
Query!
State/province [3]
0
0
PR
Query!
Country [4]
0
0
Brazil
Query!
State/province [4]
0
0
RJ
Query!
Country [5]
0
0
Brazil
Query!
State/province [5]
0
0
SP
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
British Columbia
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Ontario
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Quebec
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Bordeaux
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Creteil
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Lyon cedex 04
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Paris
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Vandoeuvre les Nancy
Query!
Country [14]
0
0
Spain
Query!
State/province [14]
0
0
Andalucia
Query!
Country [15]
0
0
Spain
Query!
State/province [15]
0
0
Cataluña
Query!
Country [16]
0
0
Spain
Query!
State/province [16]
0
0
Navarra
Query!
Country [17]
0
0
Spain
Query!
State/province [17]
0
0
Madrid
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary goal of this study was to determine the rate of confirmed best cumulative
complete molecular response (CMR) within the first year of study therapy with imatinib or
nilotinib. The study also explored the impact and significance of the achieved CMR on patient
outcomes (progression free survival (PFS), event free survival (EFS) and overall survival
(OS), characterized the kinetics of CMR achieved in both treatment arms and after the
cross-over.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00760877
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00760877
Download to PDF