Patients with newly diagnosed acute GVHD grades II to IV
Conditions
Interventions
Trade Name: Uvadex
Product Name: Methoxsalen
Pharmaceutical Form: Solution for blood fraction modification
INN or Proposed INN: methoxsalen
CAS Number: 298-81-7
Concentration unit: µg/ml microgram(s)
Sponsors
AKH Wien, Klinik für Innere Medizin I, Onkologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint is the complete resolution of GVHD manifestations without additional therapy for GVHD before response is evaluated on day 28 (week 4) after study initiation. Patients who require additional therapy for GVHD in the first 4 weeks after study initiation are considered to be treatment failures for the primary endpoint. Patients who die within the first 4 weeks after start of study regardless of GVHD status at the time of death are also regarded as treatment failures. ;Secondary Objective: The following secondary endpoints will be assessed and compared between study arms: Complete response rate by day 56 and day 84 after study initiation Time to complete resolution of acute GVHD to first-line therapy Duration of response to first-line therapy of acute GVHD Cumulative dose ofsteroids in mg/kg/day from day 0 to days 28 and 56 after study initiation Time to discontinuation of steroids as first-line therapy of acute GVHD Percent of patients in need of secondary treatment for acute GVHD Complete response rate to secondary treatment of acute GVHD assessed on day 28 after start of second-line therapy Incidence of bacterial, viral and fungal infections until day 84 and 6 months after study initiation Incidence of recurrence of malignant disease at 6 months and 12 months after study initiation Transplant-related mortality at 6 months and 12 months after study initiation Overall survival at day 6 months and 12 months after study initiation Side effects of ECP ;Primary end point(s): The primary endpoint is the complete resolution of GVHD manifestations without additional therapy for GVHD before response is evaluated on day 28 (week 4) after study initiation. Patients who require additional therapy for GVHD in the first 4 weeks after study initiation are considered to be treatment failures for the primary endpoint. Patients who die within the first 4 weeks after start of study regardless of GVHD status at the time of death are also regarded a | — |
Countries
Austria, Germany
Outcome results
None listed