Prevention of graft-against-host disease in patients treated with allogeneic stem cell transplantation: Possible role of extracorporeal photophoresis

Prevention of graft-versus-host disease in patients treated with allogeneic stem cell transplantation: Possible role of extracorporeal photophoresis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000614-39-NO

Enrollment

156

Registered

2017-03-01

Start date

2017-03-22

Completion date

Unknown

Last updated

2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft-versus-host disease (GVHD), both acute and chronic untill one year after allogeneic stam cell transplatation

Interventions

Trade Name: UVADEX 20 MCG/ML SOLUTION FOR BLOOD FRACTION MODIFICATION Product Name: UVADEX (METHOXSALEN) Product Code: 05-3888 Pharmaceutical Form: Solution for blood fraction modification

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients > 18 yrs diagnosed with acute or chronic leukemia, chronic myeloproliferative disease, myelodysplastic syndromes and lymphomas according to WHO-criteria and that are suitable fora first-time allogeneic stem cell transplatation according to our national guidelines. -Provide written consent to participate -Understand Norwegian or English -No previous history of malignant disease -No contraindication to ECP-treatment or undergone previous ECP treatment 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: In addition to those regarding eligibility for transplantation itself: -Unwilling to provide written consent to participate -Unable to cooperate as judged by the responsible physician -ECOG status > 2 at time of inclusion -Using anti-inflammatory or cytotoxic drugs other than those that are part of the treatment of the current hematological malignancy -Known allergy to psoralen or citrate products

Design outcomes

Primary

Measure	Time frame
Main Objective: Reduce graft-versus-host disease;Secondary Objective: Mortality;Primary end point(s): Fraction of graft-versus-host disease ;Timepoint(s) of evaluation of this end point: 1 year after start of transplantation	—

Secondary

Measure	Time frame
Secondary end point(s): Mortality;Timepoint(s) of evaluation of this end point: 1 year after start of transplantation	—

Countries

Norway

Contacts

Public ContactHEAD OF DEPARTMENT

OSLO UNIVERSITY HOSPITAL

gtjonnfj@ous-hf.no4723070713

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026