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A Canadian Open-label, Multicenter, Expanded Access Study of Oral Nilotinib in Adult Patients With Imatinib-resistant or -Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase


Phase 3
18 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia

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Trial Information

A Canadian Open-label, Multicenter, Expanded Access Study of Oral Nilotinib in Adult Patients With Imatinib-resistant or -Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase


Inclusion Criteria:



- Imatinib resistant or intolerant Philadelphia chromosome positive CML in blast crisis

- Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated
phase

- Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic
phase

- CML patients who have been treated with an investigational tyrosine kinase inhibitor
who otherwise meet the definition of imatinib resistance or intolerance

- World Health Organization (WHO) performance status ≤ 2

Exclusion Criteria:

- Cytopathologically confirmed central nervous system (CNS) infiltration

- Impaired cardiac function

- Use of therapeutic coumarin derivatives

- Acute chronic liver or renal disease unrelated to tumor

- Other uncontrolled medical conditions

- Treatment with hematopoeitic colony stimulating factors

- Treatment with medications that have potential to prolong the QT interval

- Another malignancy currently clinically significant or requires active intervention

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Canada: Health Canada

Study ID:

CAMN107ACA01

NCT ID:

NCT00413270

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Imatinib resistant,
  • Imatinib intolerant,
  • CML- blast crisis,
  • CML- Accelerated phase,
  • CML- chronic phase,
  • nilotinib,
  • Chronic myelogenous leukemia,
  • blast crisis,
  • accelerated phase,
  • chronic phase
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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