Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT04291261
Eligibility 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 in accordance with Glucksberg grade II-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 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.
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 \<2 mg/dL unless the elevation is known to be due to Gilbert syndrome or aGvHD within 3 days before screening.
9. ALT/SGPT and AST/SGOT must be \<5 x the upper limit of the normal range within 3 days before screening.
10. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol.
11. Written informed consent from patient.
12. 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 Criteria:
1. Progressive or relapsed malignancy
2. Uncontrolled active infection
3. Patients with chronic GvHD
4. History of or current diagnosis of progressive multifocal leukoencephalopathy (PML)
5. Pregnant or nursing (lactating) women
6. Use of other drugs for the treatment of acute GvHD apart from ongoing 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 carcinoma
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/μl
18. Coagulopathy
19. Known photosensitive disease like systemic lupus erythematosus, porphyrias or albinism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04291261
Study Brief:
Protocol Section:
NCT04291261