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

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ClinicalTrials.gov Identifier: NCT01126892
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Drug: Nilotinib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2009
Primary Completion Date : April 2011
Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: Nilotinib Drug: Nilotinib

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response [ Time Frame: 24 months ]
  2. To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study [ Time Frame: 24 months ]
  3. To follow loss of HR (after previous confirmed HR for AP and CHR for CP) [ Time Frame: 3, 6 and 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126892

Hospital San José, Bogotá, Colombia
Bogota, Colombia
Banco Municipal de Sangre
Caracas, Venezuela
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01126892     History of Changes
Other Study ID Numbers: CAMN107ACO01
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced Disease,

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Neoplastic Processes
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action