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

Primary Purpose

Chronic Myelogenous Leukemia

Status
No longer available
Phase
Locations
Canada
Study Type
Expanded Access
Intervention
nilotinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Chronic Myelogenous Leukemia focused on measuring Imatinib resistant,, Imatinib intolerant,, CML- blast crisis,, CML- Accelerated phase,, CML- chronic phase,, nilotinib,, Chronic myelogenous leukemia,, blast crisis,, accelerated phase,, chronic phase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 18, 2006
Last Updated
July 12, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00413270
Brief Title
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

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
No longer available
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
nilotinib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Novartis Investigative Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Novartis Investigative Site
City
Burnaby
State/Province
British Columbia
Country
Canada
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Novartis Investigative Site
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Novartis Investigative Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Novartis Investigative Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Novartis Investigative Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
q
Country
Canada
Facility Name
Novartis Investigative Site
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Novartis Investigative Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Novartis Investigative Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Novartis Investigative Site
City
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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