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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/NCT00054613




Registration number
NCT00054613
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 Plus Standard Therapy to Treat Chronic Graft-versus-Host Disease
Scientific title
A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-versus-Host Disease
Secondary ID [1] 0 0
GvHD-SK1
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
Respiratory 0 0 0 0
Other respiratory disorders / diseases
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
- Documented skin disease classical for chronic GvHD (e.g. hypopigmentation,
hyperpigmentation, lichenoid lesions, sclerodermatous lesions)greater than or equal to
100 days post transplantation.

- Patients with documented chronic GvHD that is corticosteroid refractory,
corticosteroid dependent or corticosteroid intolerant.

- Women of childbearing potential must agree to use a reliable method of birth control
for the duration of this study.

- Patients must weight at least 40 kg (88 lbs.)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active gastrointestinal bleeding

- Previous treatment with ECP

- Females who are pregnant and/or lactating

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Peter MacCallum - East Melbourne
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Illinois
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United States of America
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Massachusetts
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United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Austria
State/province [10] 0 0
Vienna
Country [11] 0 0
France
State/province [11] 0 0
Lyon Cedex 03
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
Germany
State/province [13] 0 0
Dresden
Country [14] 0 0
Germany
State/province [14] 0 0
Essen
Country [15] 0 0
Germany
State/province [15] 0 0
Leipzig
Country [16] 0 0
Germany
State/province [16] 0 0
Munchen
Country [17] 0 0
Italy
State/province [17] 0 0
Florence
Country [18] 0 0
Italy
State/province [18] 0 0
Genova
Country [19] 0 0
Portugal
State/province [19] 0 0
Lisboa
Country [20] 0 0
Slovakia
State/province [20] 0 0
Bratislava
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Switzerland
State/province [22] 0 0
Basel
Country [23] 0 0
Turkey
State/province [23] 0 0
Ankara
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Yorkshire
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Glasgow

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 photoimmune therapy with
UVADEX (ECP) added to standard therapy is effective in the treatment of chronic
graft-versus-host disease (GvHD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00054613
Trial related presentations / publications
Smith EP, Sniecinski I, Dagis AC, Parker PM, Snyder DS, Stein AS, Nademanee A, O'Donnell MR, Molina A, Schmidt GM, Stepan DE, Kapoor N, Niland JC, Forman SJ. Extracorporeal photochemotherapy for treatment of drug-resistant graft-vs.-host disease. Biol Blood Marrow Transplant. 1998;4(1):27-37. doi: 10.1016/s1083-8791(98)90007-6.
Greinix HT, Volc-Platzer B, Knobler RM. Extracorporeal photochemotherapy in the treatment of severe graft-versus-host disease. Leuk Lymphoma. 2000 Feb;36(5-6):425-34. doi: 10.3109/10428190009148389.
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/NCT00054613