Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

Chronic Myelogenous Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00413270
• Other study ID #: CAMN107ACA01
• Status: No longer available
• Phase: Phase 3
• First received: December 18, 2006
• Last updated: July 12, 2011
• Start date: December 2006

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Expanded Access

Clinical Trial Summary

This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Blast Crisis
• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• nilotinib

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Brampton	Ontario
Canada	Novartis Investigative Site	Burnaby	British Columbia
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Moncton	New Brunswick
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Oshawa	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Saskatoon	Saskatchewan
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	St. John's	Newfoundland and Labrador
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Windsor	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada,