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OpenTrials
Completed

NCT Number: NCT00786812

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

Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the [CAMN107A2109] study

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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 4

Primary location

Novartis Investigative Site, Belo Horizonte, Minas Gerais, Brazil

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients currrently participating in Novartis study CAMN107A2109
  • imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)
  • males or females ≥18 years of age
  • WHO Performance Status of ≤ 2
  • patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor

Exclusion criteria

  • Impaired cardiac function; use of therapeutic coumarin derivatives
  • patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days
  • patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
  • patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy
  • ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy

Treatment and study plan

Nilotinib

Drug

Primary outcomes

  1. Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months

    Time frame: 3 - 24 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: MACS0439

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 6, 2008
Registry last updated
Feb 23, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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