A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)
18 Years
N/A
Both
Chronic Graft Versus Host Disease
Trial Information
A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)
This is an open-label study (patients and study staff will know the identity of treatments
assigned during the study) in patients with chronic graft-versus-host disease (cGvHD).
Chronic graft-versus-host disease (a donator-versus-recipient-disease) is a complication
that can occur after a blood stem cell or bone marrow transplant with cells from a related
or unrelated donator. During cGvHD, the transplanted cells attack the recipient's body.
Patients with cGVHD who meet entry criteria for the study will be randomly assigned to
receive standard of care treatment for 26 weeks or standard or care treatment with
extracorporeal photopheresis (ECP) for 26 weeks. Standard of care treatment consists of
orally (taken by mouth) administered corticosteroids (drugs that reduce inflammation) and
cyclosporine (CsA)or Tacrolimus ( drugs that suppress the patient's immune response). ECP
therapy is a process that takes place in a device where the investigational drug UVADEX
(methoxsalen) is injected into a germ-free bag mixed with the patient's white blood cells.
After the blood cells have absorbed the drug and are exposed to ultraviolet A (UVA)
radiation, the blood cells are injected back into the patient's body. During the study, a
third party assessor at each study center who will be blinded (will not know) to treatment
will assess the condition each patient's skin and oral mucosa at protocol-specified visits
and will complete a total skin score for all patients . The study will consist of 3 phases:
a screening phase, an open label treatment phase and an end-of-study (or early withdrawal)
phase. The duration of patient participation will be 28 weeks and patient safety will be
monitored throughout the study.
Inclusion Criteria:
- Have new onset of moderate or severe cGvHD as assessed by the NIH Consensus Criteria
Clinical Assessment (staging and severity) with onset within 2 years of
transplantation (Patients with prior acute GvHD should be on a stable dose of <0.5
mg/kg daily prednisone, or equivalent, for at least 2 weeks prior to study entry.
Prior ECP for patients with acute GvHD is permitted in the study);willing to start
1.0mg/kg prednisone: Be using adequate birth control; If a woman, must have negative
pregnancy test result at screening: Be able and willing to comply with all study
procedures including providing informed consent
Exclusion Criteria:
- Be intolerant to corticosteroids; Received treatment with >2.0 mg daily prednisone,
or equivalent, for cGvHD for more than 7 days prior to baseline visit; received
treatment with prednisone for mild cGVHD with >.5mg/kg for > 14 days, Have evidence
of known infection with human immunodeficiency virus (HIV), active Hepatitis B
infection, or have uncontrolled infection requiring treatment at the time of study
entry; Requires treatment with budesonide and similar low absorption oral steroids
and steroid enema preparations; Receiving treatment with mycophenolate mofetil
(MMF),PUVA, tyrosine kinase inhibitors, anti-tumor necrosis factor (TNF) agents,
sirolimus, and bortezomib; Receiving treatment with alemtuzumab, antithymocyte
globulin (ATG) or other similar long-acting agents used for treatment of acute or
chronic GvHD or administered during the conditioning regimen <90 days prior to
randomization
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall response (complete or partial response) in cGvHD according to NIH Response Criteria
Outcome Description:
The NIH Consensus grading and severity criteria includes physical assessments of skin,oral cavity,eyes,gynecological and laboratory data and patient reports.Each domain is scored from 0 (no involvement) to 3 (severe involvement)
Outcome Time Frame:
week 28
Safety Issue:
No
Principal Investigator
Dennis parenti, MD
Investigator Role:
Study Director
Investigator Affiliation:
Therakos
Authority:
United States: Food and Drug Administration
Study ID:
10-005
NCT ID:
NCT01380535
Start Date:
November 2011
Completion Date:
June 2014
Related Keywords:
- Chronic Graft Versus Host Disease
- Extracorporeal photopheresis therapy
- Methoxsalen
- UVADEX
- Chronic graft versus host disease (cGvHD): National Institute Health Consensus Criteria
- Graft vs Host Disease
Name | Location |
|---|---|
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Parkland Memorial Hospital | Dallas, Texas 75235 |
| Vanderbilt Ingram Cancer Center | Nashville, Tennessee 37232 |
| New York Presbyterian Hospital | New York, New York 10021 |
| Stony Brook University Medical Center | Stony Brook, New York 11794 |
| Methodist Healthcare System of San Antonio | San Antonio, Texas 78229 |
| University of Miami Hospital | Miami, Florida 33136 |
| Indiana Blood and Marrow Transplantation Research | Indianapolis, Indiana 46237 |
| Medical City Dallas Hospital,Transplant center | Dallas, Texas 75230 |
| Tulane University Health Sciences Center, 1430 Tulane Avenue, Rm 7551, | New Orleans, Louisiana 70112 |
