Status:
ACTIVE_NOT_RECRUITING
Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Therakos
University Medical Center Regensburg
Conditions:
Acute-graft-versus-host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single arm phase 2 trial which includes patients with high risk acute GVHD defined as Ann Arbor score 2 or 3. The purpose of the study is to improve the outcome of these patients in terms of...
Detailed Description
This study is a single arm phase 2 study for adult patients who have acute GVHD Grade II-IV according to Glucksberg and Ann Arbor score 2 or 3 after first allogeneic stem cell transplantation. The sta...
Eligibility Criteria
Inclusion
- New onset high risk acute GvHD (Ann Arbor score 2/3 as defined in Appendix A) following allogeneic SCT. Any clinical severity in accordance with Glucksberg grade II-IV is eligible.
- 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.
- No prior systemic treatment for acute GvHD except for a maximum of 7 days of methylprednisolone ≤2 mg/kg/day (or IV methylprednisolone equivalent) during the period from 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.
- Age 18 years or older.
- Platelet count \> 25.000 (including platelet support)
- Eastern Coorperative Oncology Group (ECOG) score of 0≤2 unless due to aGvHD
- Negative pregnancy test within 10 days before start of study if the patient is a woman of child-bearing Age
- Direct bilirubin must be \<2 mg/dL unless the elevation is known to be due to Gilbert syndrome or aGvHD within 3 days before screening.
- ALT/SGPT and AST/SGOT must be \<5 x the upper limit of the normal range within 3 days before screening.
- Females/Males who agree to comply with the applicable contraceptive requirements of the protocol.
- Written informed consent from patient.
- Biopsy of acute GvHD target organ is strongly recommended but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not enroll within 5 working days of Initiation of systemic steroid treatment for acute GvHD are not permitted to participate
Exclusion
- Progressive or relapsed malignancy
- Uncontrolled active infection
- Patients with chronic GvHD
- History of or current diagnosis of progressive multifocal leukoencephalopathy (PML)
- Pregnant or nursing (lactating) women
- Use of other drugs for the treatment of acute GvHD apart from ongoing GvHD prophylaxis and corticosteroids
- Patients on dialysis
- Patients requiring ventilator support
- Evidence of known infection with human immunodeficiency virus (HIV) or active hepatitis B
- 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)
- History of allergic reaction to 8-MOP
- Concomitant diagnosis of malignant melanoma or basal cell carcinoma
- Hypersensitivity or allergy to both heparin and citrate products (if hypersensitive or allergic only to one, exclusion does not apply)
- Inability to tolerate extracorporeal volume shifts associated with ECP
- Presence of aphakia
- History of splenectomy
- Leucocyte count \> 25.000/μl
- Coagulopathy
- Known photosensitive disease like systemic lupus erythematosus, porphyrias or albinism
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04291261
Start Date
May 18 2020
End Date
June 1 2025
Last Update
March 30 2025
Active Locations (4)
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1
Medical University of Graz, Department of Internal Medicine
Graz, Austria, 8036
2
University Medical Center Hamburg-Eppendorf
Hamburg, Hamburg, Germany, 20246
3
University Hospital Erlangen
Erlangen, Germany, 91054
4
University Medical Center Regensburg
Regensburg, Germany, 93053