Trial Information
Pharmacokinetic Profile of Vincristine Administered Along With Imatinib in the Induction Chemotherapy of Bcr-Abl (Philadelphia Chromosome) Positive Acute Lymphoblastic Leukemia (ALL) Compared to That Without Imatinib in the Treatment of Bcr-Abl Negative ALL Patients
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
To characterize the pharmacokinetics of vincristine in two patient cohorts: Bcr-Abl positive ALL patients treated with the standard protocol with imatinib and Bcr-Abl negative ALL patients treated with the same protocol but without imatinib.
Outcome Time Frame:
18-24 months
Safety Issue:
Yes
Principal Investigator
Joseph M Brandwein, MD, FRCPC
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Ethics Review Committee
Study ID:
10-0300-CE
NCT ID:
NCT01148134
Start Date:
June 2010
Completion Date:
April 2012
Related Keywords:
- Acute Lymphoblastic Leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Philadelphia Chromosome