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Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell Transplantation: a Pharmacokinetic Study

Primary Purpose

Hematologic Malignancy

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

intravenous busulfan

About this trial

This is an interventional treatment trial for Hematologic Malignancy focused on measuring pharmacokinetics, transplantation, busulfan

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients undergoing transplantation Exclusion Criteria: -

Sites / Locations

Tom Baker Cancer CentreRecruiting

Outcomes

Primary Outcome Measures

pharmacokinetic data

Secondary Outcome Measures

Full Information

NCT ID

NCT00156858

First Posted

September 8, 2005

Last Updated

January 18, 2012

Sponsor

Alberta Health services

1. Study Identification

Unique Protocol Identification Number

NCT00156858

Brief Title

Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell Transplantation: a Pharmacokinetic Study

Official Title

Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Alberta Health services

4. Oversight

5. Study Description

Brief Summary

A study of pharmacokinetics of daily intravenous busulfan

Detailed Description

A study of pharmacokinetics of daily intravenous busulfan

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Malignancy

Keywords

pharmacokinetics, transplantation, busulfan

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

intravenous busulfan

Primary Outcome Measure Information:

Title

pharmacokinetic data

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients undergoing transplantation Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Russell, FRCp

Organizational Affiliation

Alberta Cancerboard

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel Syme, PhD

clinical_trials_tbcc@cancerboard.ab.ca

First Name & Middle Initial & Last Name & Degree

Chris Brown

First Name & Middle Initial & Last Name & Degree

Ron Anderson

First Name & Middle Initial & Last Name & Degree

James Russell

First Name & Middle Initial & Last Name & Degree

Victor Lewis

12. IPD Sharing Statement

Learn more about this trial

Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell Transplantation: a Pharmacokinetic Study

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