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

This study is currently recruiting participants.
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01227577
First received: October 21, 2010
Last updated: January 31, 2014
Last verified: January 2014

October 21, 2010
January 31, 2014
November 2010
November 2014   (final data collection date for primary outcome measure)
Rate of confirmed Complete Molecular Response (CMR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01227577 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
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)

"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."

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myelogenous Leukemia in Chronic Phase
Drug: nilotinib
nilotinib 300mg b.i.d. in adult patients with newly diagnosed Ph+ CML-CP.
Experimental: nilotinib
Intervention: Drug: nilotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
125
November 2014
November 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States
 
NCT01227577
CAMN107AUS28
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP