Clinical trial NCT00413270: Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant
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 type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Chronic Myelogenous Leukemia
Keywords: Imatinib resistant,
Imatinib intolerant,
CML- blast crisis,
CML- Accelerated phase,
CML- chronic phase,
nilotinib,
Chronic myelogenous leukemia,
blast crisis,
accelerated phase,
chronic phase
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Burnaby
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: St. John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Oshawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: