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NCT Number: NCT01126892

A Study of 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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital San José, Bogotá, Colombia, Bogotá, Colombia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Stratum 1:

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

Stratum 2:

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

Exclusion criteria

Stratum 1 and stratum 2:

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

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Nilotinib

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: ENACT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 20, 2010
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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