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OpenTrials
Completed

NCT Number: NCT00264160

Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy

This open-label, multicenter trial will evaluate the efficacy and safety of treatment with AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to imatinib mesylate therapy.

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Key information

Conditions

Leukemia, Myeloid, Chronic 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 2 / Phase 3

Primary location

Novartis Investigative Site, Haifa, Israel

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase
  • Males or females ≥ 18 years of age

Exclusion criteria

  • Impaired cardiac function
  • Acute or chronic liver or renal disease
  • Use of therapeutic coumadin
  • Central nervous system (CNS) infiltration

Additional protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

AMN107

Drug

Primary outcomes

  1. Cytogenetic response within 12 months

    Time frame: Every 6 months for 12 months

Secondary outcomes

  1. To determine the rate of hematologic response at 12 months

    Time frame: Every Visit for 12 months

  2. To determine the rate of molecular response at 12 months

    Time frame: Every 3 months for 12 months

  3. To evaluate the time to cytogenetic and molecular response

    Time frame: At 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Dec 12, 2005
Registry last updated
Mar 6, 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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