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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00054600




Registration number
NCT00054600
Ethics application status
Date submitted
5/02/2003
Date registered
6/02/2003
Date last updated
16/08/2017

Titles & IDs
Public title
Safety and Efficacy Study of Photopheresis With UVADEX to Prevent Graft-versus-Host Disease
Scientific title
A Study of Extracorporeal Photopheresis With UVADEX in the Setting of a Standard Myeloablative Conditioning Regimen for the Prevention of Graft-versus-Host Disease in Patients Undergoing an Allogeneic Bone Marrow Transplant or Peripheral Blood Stem Cell Transplant
Secondary ID [1] 0 0
GvHD Prevention
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graft-versus-Host Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methoxsalen
Treatment: Surgery - Extracorporeal Photopheresis

Treatment: Drugs: Methoxsalen


Treatment: Surgery: Extracorporeal Photopheresis
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Patients with a diagnosis of a malignancy of the blood (e.g. leukemia) for which
allogeneic bone marrow or peripheral blood stem cell transplantation is a treatment
option.

- Patients who are candidates for a standard allogenic bone marrow transplant or PBSC
transplant.

- Patients must have adequate renal, hepatic, pulmonary and cardiac function to enable
the patient to tolerate shifts in the volumes of body fluids associated with
extracorporeal photopheresis, as determined by the physician's clinical judgement.

- Patients must weigh at least 40 kg (88 lbs)
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who have received a prior bone marrow transplant or peripheral blood stem
cell transplant.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
8006 - East Melbourne
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Brazil
State/province [7] 0 0
Jau
Country [8] 0 0
Brazil
State/province [8] 0 0
Rio de Janeiro
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Paulo
Country [10] 0 0
Germany
State/province [10] 0 0
Munchen
Country [11] 0 0
Italy
State/province [11] 0 0
Florence
Country [12] 0 0
Italy
State/province [12] 0 0
Genova
Country [13] 0 0
Portugal
State/province [13] 0 0
Lisbon
Country [14] 0 0
Slovakia
State/province [14] 0 0
Bratislava
Country [15] 0 0
Turkey
State/province [15] 0 0
Ankara
Country [16] 0 0
United Kingdom
State/province [16] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mallinckrodt
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether Extracorporeal Photopheresis with UVADEX
(ECP) prior to bone marrow or peripheral blood stem cell transplantation is effective in the
prevention of Graft-versus-Host Disease (GvHD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00054600
Trial related presentations / publications
Shlomchik WD, Couzens MS, Tang CB, McNiff J, Robert ME, Liu J, Shlomchik MJ, Emerson SG. Prevention of graft versus host disease by inactivation of host antigen-presenting cells. Science. 1999 Jul 16;285(5426):412-5. doi: 10.1126/science.285.5426.412.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00054600