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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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Terminated
CT.gov ID
NCT01148134
Collaborator
(none)
10
Enrollment
1
Location
22
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 positive. This cohort of patients will receive vincristine along with imatinib in the induction chemotherapy regimen. The second cohort includes patients with ALL that are Bcr-Abl negative. This cohort of patients will receive vincristine without imatinib in the induction chemotherapy regimen. This study involves blood draws beginning on day 7 of the treatment protocol and these samples will be analyzed for pharmacokinetic parameters.

Imatinib and vincristine are both metabolized by the hepatic CYP 450 enzyme system. Imatinib is an inhibitor of the system and co-administration of imatinib and vincristine has the potential to increase the blood level of vincristine. This could explain the increased level of neurotoxicity that is currently being seen with the co-administration of these two agents in the treatment of Bcr-Abl positive ALL.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    10 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    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
    Study Start Date :
    Jun 1, 2010
    Actual Primary Completion Date :
    Apr 1, 2012
    Actual Study Completion Date :
    Apr 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Bcr-Abl positive ALL
    Bcr-Abl negative ALL

    Outcome Measures

    Primary Outcome Measures

    1. 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. [18-24 months]

    Secondary Outcome Measures

    1. To determine if there are any objective differences in peripheral neuropathy and ileus between the two groups at Day 14, and to correlate these neurologic assessments with PK results. [18-24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Joseph M Brandwein, MD, FRCPC, Princess Margaret Hospital, Canada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT01148134
    Other Study ID Numbers:
    • 10-0300-CE
    First Posted:
    Jun 22, 2010
    Last Update Posted:
    Jan 11, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Jan 11, 2013