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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00282503




Registration number
NCT00282503
Ethics application status
Date submitted
24/01/2006
Date registered
26/01/2006
Date last updated
16/08/2017

Titles & IDs
Public title
Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease
Scientific title
A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease
Secondary ID [1] 0 0
Acute GvHD-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute 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+ECP, Methylprednisolone
Treatment: Surgery - Ecp

Active comparator: methylprednisolone equivalent. - 2mg/kg daily will be administered initially and may be tapered according to a tapering schedule provided in the protocol.

Experimental: Uvadex+ECP - Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen:

* Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period),
* Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days


Treatment: Drugs: Methoxsalen+ECP, Methylprednisolone
Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen:

* Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period),
* Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days within a week, but there should never be \> 4 days between the ECP treatments within a week.)

Methylprednisolone will be started at 2mg/kg daily dose and may be tapered by reducing dose each week at the following reductions:

Daily Dose (mg/kg)

1 1.5 2 1.0 3 0.70 4 0.50 5 0.40 6 0.30 7 0.20 8 0.10

Treatment: Surgery: Ecp
ECP or Extra Corporeal Phototherapy will be used with UVADex
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.
Timepoint [1] 0 0
8 weeks

Eligibility
Key inclusion criteria
1. Signed informed consent must be obtained prior to conducting any study procedure.
2. Patients must be greater than or equal to 18 years old and weigh greater than or equal to 40 kg (88 lb).
3. Patients must have received an allogeneic hematopoietic BMT or PBSCT with myeloablative or reduced-intensity conditioning and have a new onset of acute GvHD, Grades II to III, which includes the skin and developed within 100 days following an allo-HPCT.
4. Patients must have received an allogeneic hematopoietic BMT or PBSCT from a related or unrelated donor that is matched at a minimum at the HLA-A, -B, and -DR loci (i.e., at least a 6 out of 6 match). HLA-A and -B match should be determined by serologic testing, and HLA-DR should be matched by molecular methods.
5. Patients must be receiving only a calcineurin inhibitor at study entry as part of their acute GvHD prophylactic regimen. Patients may have received additional immunosuppressants for acute GvHD prophylaxis prior to study entry.
6. Patients must have a Karnofsky performance greater than or equal to 50.
7. Patients must be able and willing to comply with all study procedures.
8. Patients must receive, or must have received, the first corticosteroid dose of approximately 2.0 mg/kg/day but no more than 2.5 mg/kg/day (methylprednisolone equivalent) within 24 hours of the initial diagnosis of Grade II to III acute GvHD. (Up to 2.5 mg/kg/day is allowed for inadvertent dosing fluctuations for reasons other than lack of response.)
9. Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (acceptable methods include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening. Male patients must also commit to using adequate contraceptive precautions (condoms). All patients (both males and females of childbearing potential) must commit to using adequate contraceptive precautions throughout their participation in the study and for at least 3 months following their last ECP treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have been diagnosed with chronic GvHD, including de novo chronic GvHD, prior to 100 days following an allo-HPCT.
2. Patients who have received donor lymphocyte infusions.
3. Patients with uncontrolled life-threatening infections.
4. Patients who have a white blood cell (WBC) count < 1.5 x 10^9/L (1,500/mcL).
5. Patients who have a platelet count < 20.0 x 10^9/L (20,000/mcL), despite platelet transfusion.
6. Patients whose total bilirubin is greater than or equal to 22 mg/dL.
7. Patients who have an International Normalized Ratio (INR) greater than or equal to 2.
8. Patients who are enrolled in any concomitant investigation for the treatment of acute GvHD.
9. Patients who are unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, hepatic encephalopathy, or hepatorenal syndrome.
10. Female patients whose hemoglobin (Hgb) is < 8.5 g/dL or male patients whose Hgb is < 10.0 g/dL at screening, despite packed red blood cell transfusion.
11. Patients who have a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.
12. Patients who have a known hypersensitivity or allergy to Oxsoralen (methoxsalen).
13. Patients who have a known hypersensitivity or allergy to both heparin and citrate products.
14. Female patients who are pregnant and/or lactating.
15. Patients who have co-existing melanoma, basal cell or squamous cell skin carcinoma, aphakia, photosensitive disease (e.g., porphyria, systemic lupus erythematosus, or albinism), white blood cell count > 25,000 cells/mm3, previous splenectomy, or coagulation disorders.

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?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Saint Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
NSW 2145 - Westmead
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
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
South Dakota
Country [6] 0 0
Austria
State/province [6] 0 0
Vienna
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Liege
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Montreal
Country [13] 0 0
France
State/province [13] 0 0
Bordeaux
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
Germany
State/province [15] 0 0
Dresden
Country [16] 0 0
Germany
State/province [16] 0 0
Erlangen
Country [17] 0 0
Germany
State/province [17] 0 0
Essen
Country [18] 0 0
Germany
State/province [18] 0 0
Hamburg
Country [19] 0 0
Germany
State/province [19] 0 0
Koln
Country [20] 0 0
Germany
State/province [20] 0 0
Leipzig
Country [21] 0 0
Germany
State/province [21] 0 0
Munchen
Country [22] 0 0
Germany
State/province [22] 0 0
Regensburg
Country [23] 0 0
Germany
State/province [23] 0 0
Rostock
Country [24] 0 0
Germany
State/province [24] 0 0
Wurzburg
Country [25] 0 0
Italy
State/province [25] 0 0
Genova
Country [26] 0 0
Italy
State/province [26] 0 0
Sienna
Country [27] 0 0
Netherlands
State/province [27] 0 0
Utrecht
Country [28] 0 0
Switzerland
State/province [28] 0 0
Basel
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Newcastle
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Rotheram Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mallinckrodt
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PRA Health Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00282503