NCT01071486

Brief Summary

Between 100 up to 200 adults undergoing HSCT for their primary disease will be included in this pharmacokinetic/pharmacogenetic study. In the preparative protocol Busulfan (BU)will be included as indicated in a known protocol. The GST polymorphism (A1,M1,T1 and P1) will be investigated using real time PCR. A correlation between pharmacokinetic parameters and patients polymorphism will be performed using known statistical technics for comparison. The aims of this study are, to correlate the demographic data, clinical presentation, clinical outcomes of the included individuals, the BU kinetics and the GST polymorphism and to establish an outcome "map" for those who receive HSCT for their primary disease.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

3.2 years

First QC Date

February 18, 2010

Last Update Submit

November 8, 2015

Conditions

Busulfan Pharmacokinetic AnalysisGST Genetic Polymorphism

Keywords

BusulfanGlutathione S-transferaseGenetic polymorphismHVODGVHD

Outcome Measures

Primary Outcomes (1)

  • Hepatic Veno-Occlusive Disease, Graft versus host disease

    every week after HSCT up to 6 month

Interventions

Hematological Stem Cell TransplantationDRUG

Oral or Intravenous Busulfan as part of the preparative protocol for transplantation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant or Benign Diseases who need hematological stem cell transplantation as part of their treatment
  • Busulfan should be part of the preparative protocol

You may not qualify if:

  • Known sensitivity or allergy to Busulfan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacology Unit

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

August 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

IL(1)