Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome and /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase (`MACS1252)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01061177
First received: February 1, 2010
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.


Condition Intervention Phase
Leukemia, Myeloid
Drug: Nilotinib
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIIb, Multicentre, Open-label Study of Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome and/or BCR-ABL Positive CML in Chronic Phase

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of complete molecular response (CMR). Levels of BCR-ABL transcripts will be determined by RQ-PCR testing of peripheral blood and analysed at an appropriate national EUTOS reference laboratory. [ Time Frame: after 18 months of study drug ] [ Designated as safety issue: No ]
    CMR is defined as undetectable BCR-ABL transcripts by quantitative RT-PCR in a peripheral blood sample of at least 10 ml with a minimum sensitivity of 1:10,000.


Secondary Outcome Measures:
  • Rate of early progression to accelerated phase and blast crisis in year 1 and 2 and the rate of events in patients achieving a CMR at 1 year [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
  • The rate of MMR at, as well as by, 12 and 24 months; the rate of CCyR at, as well as by , 12 and 24 months; the rate of CHR at, as well as by, 12 and 24 months [ Time Frame: at as welll as by 12 and 24 months ] [ Designated as safety issue: No ]
  • The rate of early events, event free survival, overall survival; and safety and tolerability of nilotinib [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
  • Exploratory endpoints patterns [ Time Frame: at, as well as, by 3, 6, 9, 12, 15, 21, and 24 months ] [ Designated as safety issue: No ]
    Exploratory endpoints include the kinetics of MMR and the dynamics of molecular response and potential patterns


Enrollment: 1088
Study Start Date: May 2010
Study Completion Date: July 2014
Primary Completion Date: July 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:

  1. Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph) chromosome
  2. Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR are also eligible
  3. WHO performance status 0-2
  4. Laboratory assessments within normal limits
  5. Written informed consent prior to any study procedures being performed

Exclusion Criteria:

  1. Known impaired cardiac function
  2. History of acute or chronic pancreatitis
  3. Impaired gastrointestinal function or disease that may alter the absorption of study drug
  4. Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)
  5. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  6. Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061177

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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: NCT01061177     History of Changes
Other Study ID Numbers: CAMN107EIC01, 2009-017775-19
Study First Received: February 1, 2010
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Bosnia: Federal Ministry of Health
Bulgaria: Bulgarian Drug Agency
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Leukemia
myeloid
myelogenous
chronic BCR-ABL positive
Nilotinib

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Philadelphia Chromosome
Chromosome Aberrations
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Translocation, Genetic

ClinicalTrials.gov processed this record on October 21, 2014