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Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients (ENESTxtnd)

This study is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01254188
First received: December 2, 2010
Last updated: May 29, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase


Condition Intervention Phase
Chronic Myeloid Leukemia
 Drug: Nilotinib
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase

Resource links provided by NLM:

Drug Information available for: Nilotinib
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Major Molecular Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete Cytogenetic Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 12 months, 24 months ] [ Designated as safety issue: No ]
  • Duration of Major Molecular Response [ Time Frame: 3, 6, 9, 12, 15, 18, 21, 24 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib
Other Name: AMN107

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry

Exclusion Criteria:

  • Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
  • Uncontrolled congestive heart failure or hypertension
  • Myocardial infarction or unstable angina pectoris within past 12 months
  • Known T315I mutations
  • QTcF >450 msec
  • Significant arrhythmias

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254188

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 132 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01254188     History of Changes
Other Study ID Numbers: CAMN107E2401
Study First Received: December 2, 2010
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration
Algeria: Ministry of Health
Argentina: Ministry of Health
Australia: Institutional Review Board
Bahrain: Institutional Review Board
Brazil: Ministry of Health
Canada: Health Canada
Egypt: Ministry of Health and Population
India: Drugs Controller General India
Israel: Ministry of Health
Lebanon: Institutional Review Board
Malaysia: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Morocco: Ministry of Public Health
Philippines: Philippine Food and Drug Administration
Qatar: Institutional Review Board
Russia: Ministry of Health
Saudi Arabia: Saudi Food & Drug Administration
South Africa: Department of Health

Keywords provided by Novartis:
Chronic myeloid leukemia,
CML,
nilotinib,
myelogenous,
Philadelphia chromosome

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
 Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013