New onset high risk acute GvHD following allogeneic SCT MedDRA version: 20.0 Level: LLT Classification code 10018653 Term: Graft-versus-host disease System Organ Class: 100000004870
Conditions
Interventions
Trade Name: UVADEX
Pharmaceutical Form: Solution for blood fraction modification
Sponsors
Department of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. New onset high risk acute GvHD (Ann Arbor score 2/3 as defined in Appendix A) following allogeneic SCT. Any clinical severity (Glucksberg grade I-IV) is eligible. 2. Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood). Recipients of non-myeloablative and myeloablative transplants are eligible. 3. No prior systemic treatment for acute GvHD except for a maximum of 7 days of methylprednisolone =2 mg/kg/day (or IV Methyprednisolone equivalent) during the period from the initiation of systemic steroid treatment for acute GvHD until study therapy begins. Topical skin steroid treatment and non-absorbable oral steroid treatment for GI GvHD are permissible. 4. Age 18 years or older. 5. Platelet count > 25.000 (including platelet support) 6. Eastern Coorperative Oncology Group (ECOG) score of 0=2 unless due to aGvHD 7. Negative pregnancy test within 10 days before start of study if the patient is a woman of child-bearing age 8. Direct bilirubin must be =65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: 1. Progressive or relapsed malignancy 2. Uncontrolled active infection 3. Patients with chronic GvHD 4. History of or current diagnosis of progressive multifocal leu-koencephalopathy (PML) 5. Pregnant or nursing (lactating) women 6. Use of other drugs for the treatment of acute GvHD apart from on-going GvHD prophylaxis and corticosteroids 7. Patients on dialysis 8. Patients requiring ventilator support 9. Evidence of known infection with human immunodeficiency virus (HIV) or active hepatitis B 10. Investigational agent within 30 days of enrollment without approval from the Sponsor-Investigator (PI). (Off-label use of medication is not considered investigational unless in context of a formal study) 11. History of allergic reaction to 8-MOP 12. Concomitant diagnosis of malignant melanoma or basal cell carci-noma 13. Hypersensitivity or allergy to both heparin and citrate products (if hypersensitive or allergic only to one, exclusion does not apply) 14. Inability to tolerate extracorporeal volume shifts associated with ECP 15. Presence of aphakia 16. History of splenectomy 17. Leucocyte count > 25.000/ul 18.Coagulopathy 19. Known photosensitive disease like systemic lupus erythematosus, porphyrias or albinism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve day 28 GvHD complete response rate for high risk (Ann Arbor Score 2/3) GvHD patients from the historical rate of 37% to 52% by treatment with ECP and high dose systemic corticosteroids (2 mg/kg). ;Secondary Objective: To decrease 6-month NRM from the historical rate of 30% to 20% in patients treated on this clinical trial.;Primary end point(s): The primary endpoint for this clinical study is the proportion of complete response (that is, the per-cent of patients with skin, liver, and GI GvHD all stage 0) at day 28 of study treatment.;Timepoint(s) of evaluation of this end point: At day 28 of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: 1. Overall survival at 1 year 2. Cumulative incidence of NRM at 6 months and at 1 year 3. Overall response rate (CR + PR) at day 28 and 56. PR is defined as improvement in one or more organs involved with GvHD symptoms without progression in others. For a response to be scored as PR on day 28 or 56, the patient must be in PR on day 28 or 56 and have had no intervening non-study therapy for acute GvHD. 4. Cumulative incidence of treatment-refractory GvHD (defined as ab-sence of CR or PR on day 28 of treatment or who receive additional immunosuppression prior to day 28) 5. Cumulative incidence of severe GI GvHD stage 3 or 4 6. Time to discontinuation of steroid therapy 7. Number of lines of GvHD therapy (defined as the initiation of a new acute GvHD therapy, regard-less of duration) 8. Cumulative incidence of chronic GvHD 9. Number of serious infections (defined as grade 3 by the Blood and Marrow Transplant Clinical Trials Network) ;Timepoint(s) of evaluation of this end point: - on days 28 and/or 56 - Overall survival after 1 year - Cumulative incidence of NRM at 6 months and at 1 year | — |
Countries
Austria, Germany
Contacts
Public ContactFrancis A. Ayuk
Department of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf
Outcome results
None listed