A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase (ENACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01126892
First received: May 18, 2010
Last updated: November 13, 2012
Last verified: November 2012

May 18, 2010
November 13, 2012
January 2009
April 2011   (final data collection date for primary outcome measure)
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study. [ Time Frame: between 6 and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01126892 on ClinicalTrials.gov Archive Site
  • To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • To follow loss of HR (after previous confirmed HR for AP and CHR for CP) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myeloid Leukemia
Drug: Nilotinib
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
6
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Stratum 1:

  1. Currently participating in Novartis study CAMN107A2109
  2. Written signed and dated informed consent prior to any study procedures being performed

Stratum 2:

  1. Male or female
  2. > 18 years
  3. ECOG 0,1,2
  4. ASL/ALT <= 2.5 ULN or <= 5.0 ULN
  5. Alcaline Phosfatase <= 2.5 ULN
  6. Serum Bilirrubin <= 1.5 ULN
  7. Serum Creatinine <= 1.5 ULN or creatinine clearance >=50 ml/min / 24 hours
  8. Serum Lipase <= 1.5 ULN

Exclusion Criteria:

Stratum 1 and stratum 2:

  1. Reduction of the cardiac function
  2. Use of Coumadin
  3. Other severe medical concurrent conditions
  4. Treatment with medications that prolonged the QT interval.
  5. Mayor surgery 15 days before the inclusion in the protocol
  6. Pregnant women or lactation

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
Colombia,   Venezuela
 
NCT01126892
CAMN107ACO01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
Novartis
November 2012

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