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

This study has been terminated.

(Analysis of the first 10 patients did not show anyt trend toward differences in PK profiles between imatinib vs no imatinib groups.)

Sponsor:

Information provided by (Responsible Party):

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT01148134

First received: June 18, 2010

Last updated: January 10, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 18, 2010

Last Updated Date

January 10, 2013

Start Date ^ICMJE

June 2010

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 18-24 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01148134 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: 18-24 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with Acute Lymphoblastic Leukemia will be selected from the Leukemia Clinic at Princess Margaret Hospital.

Condition ^ICMJE

Acute Lymphoblastic Leukemia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Bcr-Abl positive ALL
Bcr-Abl negative ALL

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01148134

Other Study ID Numbers ^ICMJE

10-0300-CE

Has Data Monitoring Committee

Not Provided

Responsible Party

University Health Network, Toronto

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joseph M Brandwein, MD, FRCPC

Princess Margaret Hospital, Canada

Information Provided By

University Health Network, Toronto

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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