Status:
TERMINATED
Pharmacokinetic Profile of Vincristine Administered With Imatinib for Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) Compared to That Without Imatinib for Bcr-Abl Negative ALL
Lead Sponsor:
University Health Network, Toronto
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
This study is characterizing the pharmacokinetics of vincristine using two different cohorts of patients. The first cohort includes patients with acute lymphoblastic leukemia (ALL) that are Bcr-Abl po...
Eligibility Criteria
Inclusion
- Age \>/= 18 years
- New Diagnosis of Bcr-Abl positive ALL or Bcr-Abl negative ALL
- Receiving induction chemotherapy with the standard Princess Margaret Hospital modified DFCI protocol
- Will have a functioning central venous access catheter in-situ
- Agreeing to participate in the study and sign the informed consent form
Exclusion
- Concomitant use of other agents that inhibit hepatic cytochrome CYP3A4, as these drugs may alter vincristine and imatinib levels
- Elevated liver function tests: bilirubin \>1.5xULN or AST/ALT \>2.5xULN, or documented history of chronic liver disease.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01148134
Start Date
June 1 2010
End Date
April 1 2012
Last Update
January 11 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9