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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

No longer available

CT.gov ID

NCT00413270

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelogenous Leukemia	Drug: nilotinib

Study Design

Study Type:

Expanded Access

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

Study Start Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Calgary	Alberta	Canada
2	Novartis Investigative Site	Edmonton	Alberta	Canada
3	Novartis Investigative Site	Burnaby	British Columbia	Canada
4	Novartis Investigative Site	Vancouver	British Columbia	Canada
5	Novartis Investigative Site	Moncton	New Brunswick	Canada
6	Novartis Investigative Site	St. John's	Newfoundland and Labrador	Canada
7	Novartis Investigative Site	Halifax	Nova Scotia	Canada
8	Novartis Investigative Site	Brampton	Ontario	Canada
9	Novartis Investigative Site	Hamilton	Ontario	Canada
10	Novartis Investigative Site	London	Ontario	Canada
11	Novartis Investigative Site	Oshawa	Ontario	Canada
12	Novartis Investigative Site	Ottawa	Ontario	Canada
13	Novartis Investigative Site	Toronto	Ontario	Canada	q
14	Novartis Investigative Site	Windsor	Ontario	Canada
15	Novartis Investigative Site	Montreal	Quebec	Canada
16	Novartis Investigative Site	Sherbrooke	Quebec	Canada
17	Novartis Investigative Site	Saskatoon	Saskatchewan	Canada
18	Novartis Investigative Site	Quebec		Canada