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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


N/A
18 Years
N/A
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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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

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