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
  Purpose

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 Intervention Phase
Chronic Myeloid Leukemia
Drug: Nilotinib
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: January 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT01126892

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01126892     History of Changes
Other Study ID Numbers: CAMN107ACO01
Study First Received: May 18, 2010
Last Updated: November 13, 2012
Health Authority: Colombia: Instituto Nacional De Vigilancia De Medicamentos y Alimentos
Venezuela: Instituto Nacional De Higiene Rafael Rangel

Keywords provided by Novartis:
Advanced Disease,
Resistance,
Intolerance

Additional relevant MeSH terms:
Blast Crisis
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Carcinogenesis
Cell Transformation, Neoplastic
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014