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

Phase 1

• Conditions: Graft-versus-host disease (GVHD), both acute and chronic untill one year after allogeneic stam cell transplatation; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-000614-39-NO
• Lead Sponsor: OSLO UNIVERSITY HOSPITAL HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-01
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Mortality;Timepoint(s) of evaluation of this end point: 1 year after start of transplantation