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

February 1, 2010
October 2, 2014
May 2010
July 2014   (final data collection date for primary outcome measure)
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.
Rate of complete molecular response (CMR). [ Time Frame: after 18 months of study drug ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01061177 on ClinicalTrials.gov Archive Site
  • 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
  • To evaluate the rate of annual disease progression and annual events at 12 and 24 months of treatment. [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
  • To evaluate the rate of major molecular response (MMR) after 12 and 24 months of study treatment. [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
  • To evaluate the rate of complete cytogenetic response after 12 and 24 months of study drug [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
  • To evaluate the rate of CMR (Complete Molecular response) after 12 and 24 months of study drug. [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
  • evaluate the annual rate of events in patients achieving a CMR at 12 months. [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome and /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Myeloid
Drug: Nilotinib
Other Name: AMN107
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.
 
Completed
1088
July 2014
July 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Austria,   Belgium,   Bulgaria,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   United Kingdom,   Latvia,   Lithuania,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   Slovakia,   Slovenia,   Spain,   Sweden,   Switzerland
 
NCT01061177
CAMN107EIC01, 2009-017775-19
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2014

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