RANDOMIZED CONTROLLED MULTICENTER PHASE II STUDY FOR INITIAL TREATMENT OF ACUTE GRAFT-VERSUS-HOST DISEASE WITH EXTRACORPOREAL PHOTOPHERESIS AND CORTICOSTEROIDS OR CORTICOSTEROIDS ALONE - Acute-GVHD-ECP
- Conditions
- Patients with newly diagnosed acute GVHD grades II to IV
- Registration Number
- EUCTR2008-007794-20-DE
- Lead Sponsor
- AKH Wien, Klinik für Innere Medizin I, Onkologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
- Age > 18 years
- Patients who develop after allogeneic cell transplantation new onset acute
GVHD, clinical grades II to IV will be eligible. The diagnosis of GVHD will be made on the basis of clinical features, and confirmed histologically according to standard criteria. (27,28)
- Treatment for less than 72 hours with 2 mg/kg/day prednisolone prior to
randomization and first cycle of ECP.
- Absolute neutrophil count greater than 0.5 X 109/L for at least 3 days.
Absence of uncontrolled infection.
- Karnofsky performance score > 50%
- Signed written informed consent
- Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control. If a female patient is of childbearing potential, she must have a negative pregnancy test prior to study entry and in monthly intervals thereafter.
- Patients must be able and willing to comply with all study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Patients who have received more than one prior allogeneic BMT or PBSCT
- Patients who received donor lymphocyte infusions (DLI)
- Patients who have a known hypersensitivity or allergy to 8-methoxypsoralen
- Patients with uncontrolled infections at onset of acute GVHD.
-Patients with serious hemorrhage and/or gastrointestinal bleeding
- Patients who had previous treatment with ECP.
- Patients who received treatment with prednisolone for > 72 hours.
- Patients unable to tolerate removal of > 500 ml of circulating blood volume required for the ECP procedure.
- Patients with a platelet count < 20 X 109/L despite platelet transfusions.
- Poor likelihood of full cooperation in the study and/or poor compliance anticipated.
- Patients with a serious psychiatric disorder.
- Patients who are currently participating in another study
- Patients with co-existing melanoma, basal cell or sequamous cell skin carcinoma
- Pregnant or lactating patients
- Patients with aphakia
- Patients with photosensitive disease like porphyria, systemic lupus erythematosus or albinism
- Patients with coagulation disorders
- Patients with uncontrolled acute systemic viral infection
- Patients who have a known hypersensitivity or allergy to Prednisolon or other content of Decortin-H
- Patients with HBs antigen positive active chronic hepatitis B infection
- Patients who received vaccine within previous 2 weeks
- Patients with lymphadenitis following BCG vaccine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method