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History of Changes for Study: NCT00471497
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Latest version (submitted October 23, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 9, 2007 None (earliest Version on record)
2 September 18, 2007 Recruitment Status, Contacts/Locations and Study Status
3 September 27, 2007 Study Status and Study Identification
4 October 26, 2007 Study Status and Study Description
5 March 3, 2008 Study Status and Contacts/Locations
6 July 17, 2008 Contacts/Locations, Study Status and Sponsor/Collaborators
7 July 24, 2008 Contacts/Locations and Study Status
8 August 19, 2008 Study Status and Contacts/Locations
9 September 4, 2008 Study Status
10 October 3, 2008 Study Status
11 March 27, 2009 Recruitment Status, Contacts/Locations, Study Status and Sponsor/Collaborators
12 September 18, 2009 Study Status, References and Study Identification
13 September 27, 2009 Study Status
14 November 18, 2009 References and Study Status
15 January 27, 2010 Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Study Design, Study Identification, Eligibility and Oversight
16 January 28, 2010 Outcome Measures and Study Status
17 May 27, 2010 Study Status and Contacts/Locations
18 March 7, 2012 Contacts/Locations, Study Design, Sponsor/Collaborators, Study Status, Conditions and Study Identification
19 April 12, 2012 Outcome Measures and Study Status
20 May 30, 2012 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures and Conditions
21 July 18, 2012 Contacts/Locations and Study Status
22 June 13, 2013 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures, Arms and Interventions, Study Design, Results, Eligibility and Conditions
23 October 14, 2013 Study Status
24 November 19, 2014 Contacts/Locations, Study Status, Arms and Interventions, Eligibility and Conditions
25 April 18, 2016 Contacts/Locations, Study Status and Study Design
26 November 27, 2016 Contacts/Locations, Study Status, Outcome Measures and Baseline Characteristics
27 May 25, 2017 Contacts/Locations, Study Status, Oversight, Baseline Characteristics, IPDSharing and Study Design
28 June 27, 2017 Study Status and Study Design
29 October 30, 2017 Contacts/Locations, Study Status and Study Design
30 July 29, 2018 Contacts/Locations, Study Status and References
31 October 26, 2018 Contacts/Locations, Study Status, Study Design and Study Description
32 December 6, 2018 Study Status
33 March 14, 2019 Contacts/Locations, Study Status and Study Design
34 April 3, 2019 Contacts/Locations, Study Status and Eligibility
35 April 25, 2019 IPDSharing, Study Status and Study Design
36 May 9, 2019 Study Status and Contacts/Locations
37 July 25, 2019 Study Status
38 September 9, 2019 Recruitment Status and Study Status
39 January 9, 2020 Contacts/Locations and Study Status
40 April 1, 2020 Contacts/Locations and Study Status
41 April 22, 2020 Contacts/Locations and Study Status
42 June 28, 2020 Contacts/Locations, Study Description, Study Status, IPDSharing, References and Eligibility
43 July 17, 2020 Study Status and Study Design
44 October 23, 2020 Adverse Events, Outcome Measures, Participant Flow, Baseline Characteristics, Contacts/Locations, More Information, Study Description, Study Status, Eligibility and Study Design
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Study NCT00471497
Submitted Date:  May 9, 2007 (v1)
Open or close this module Study Identification
Unique Protocol ID: CAMN107A2303
Brief Title: A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Official Title: A Phase III Multi-Center, Open-Label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2007
Overall Status: Not yet recruiting
Study Start: May 2007
Primary Completion:
Study Completion:
First Submitted: May 7, 2007
First Submitted that
Met QC Criteria:		 May 9, 2007
First Posted: May 10, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:		 May 9, 2007
Last Update Posted: May 10, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: In this study, the efficacy and safety of two nilotinib doses, 600mg once daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Detailed Description:
Open or close this module Conditions
Conditions: Myelogenous Leukemia, Chronic
Keywords: leukemia
bone marrow
leukemia symptoms
lukemia
cml
complete blood count
lymphocyte
blood cancer
leukocytes
chronic leukemia
bone marrow biopsy
leukemia research
leukemia cells
bone marrow disease
chronic myeloid leukemia
blood cancer symptoms
white blood cell diseases
chronic myelogenous leukemia
leukemia treatment
leukemia facts
leucemia
facts about leukemia
myelogenous leukemia
newly diagnosed CML
newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Crossover Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 771 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Drug: nilotinib
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of major molecular response after 12 months of treatment assessed by the degree of elimination of the cells that carry the Bcr-Abl protein in the bone marrow.
Secondary Outcome Measures:
1. To compare the rate reduction in BCR-ABL transcript levels in nilotinib treatment arms with imatinib at 12 months.
2. To compare the rate of complete cytogenetic response (CCyR) in nilotinib treatment arms with imatinib at 12 months.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion criteria

  • Chronic myelogenous leukemia in chronic phase patients within the first 6 months of diagnosis.
  • Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome

Exclusion criteria

  • Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except for no more than 2 weeks in duration of imatinib
  • Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
  • Uncontrolled or significant cardiovascular disease.
  • Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
  • Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
  • Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply
Open or close this module Contacts/Locations
Central Contact Person: Novartis U.S.
Telephone: 862 778 8300
Central Contact Backup: Novartis Basel
Telephone: 41 61 324 1111
Study Officials: Novartis
Study Chair
Novartis
Locations: United States, Ohio
Cleveland, Ohio, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services