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CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib (MACS1428)

This study is currently recruiting participants.
Verified February 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01227577
First received: October 21, 2010
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."


Condition Intervention Phase
Chronic Myelogenous Leukemia in Chronic Phase
 Drug: nilotinib
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Resource links provided by NLM:

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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of confirmed Complete Molecular Response (CMR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of CCyR, MMR, CMR and sustained CMR [ Time Frame: 4 years or at the end of the study ] [ Designated as safety issue: Yes ]
  • Time and Duration of CCyR, MMR, CMR and sustained CMR [ Time Frame: 4 years or until the end of the study ] [ Designated as safety issue: Yes ]
  • Rate and Time to progression to AP/BC [ Time Frame: 4 years or until the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: November 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nilotinib Drug: nilotinib
nilotinib 300mg b.i.d. in adult patients with newly diagnosed Ph+ CML-CP.

  Eligibility

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

Inclusion Criteria:

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.

Exclusion Criteria:

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227577

Contacts
Contact: Novartis Pharmaceuticals +1(800)340-6843

  Show 48 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: NCT01227577     History of Changes
Other Study ID Numbers: CAMN107AUS28
Study First Received: October 21, 2010
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
CML
Chronic Myelogenous Leukemia
Leukemia
CML-CP
Nilotinib

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
 Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013