An interventional study of Extracorporeal photophoresis (ECP) in Graft-Versus-Host Disease, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Prevention
The main aim is to test the preventive use of extracorporeal photophoresis (ECP) against development of graft-versus-host disease (GVHD) in patients undergoing allogeneic stem cell transplantation for hematological malignancy.
Allogeneic stem cell transplantation represents the only available long-term control and possible cure of a number of hematological malignancies. A major obstacle to this treatment is the development of graft-versus-host disease (GVHD), affecting the majority of transplanted patients to some extent. Today, combinations of various cytotoxic and immunosuppressive drugs are used to prevent and treat GVHD, but many of them are associated with severe side-effects. Extracorporeal photophoresis (ECP) offers an alternative to chemo- and immunosuppressive therapy and confers apparently only mild side effects. The postulated rationale of ECP is to treat the patient's white blood cells ex vivo with ultraviolet irradiation after sensitization with 8-methoxypsoralen to dampen their immunoactivity. After engraftment the intervention group receives 2 consecutive ECP every week in 2 weeks then 1 ECP every week in 4 weeks ( a total of 8 ECP procedures).
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 158 is above the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
(in addition to those regarding eligibility for transplantation itself):
The treatment procedure of ECP consists of three steps. First, the leukocytes are removed by apheresis; second, the mononuclear cells are primed with the photosensitizing agent 8-methoxypsoralen; then third, these cells are exposed to radiation with ultraviolet A light before they are re-infused into the patient.
Other: Extracorporeal photophoresis (ECP)
No procedure
The treatment procedure of ECP consists of three steps. First, the leukocytes are removed by apheresis; second, the mononuclear cells are primed with the photosensitizing agent 8-methoxypsoralen; then third, these cells are exposed to radiation with ultraviolet A light before they are re-infused into the patient
Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies
GVHD is measured according to internationally recognized criteria
Time frame: up to 1 year after allogeneic stamcell transplantation
Number of survivors the first year after transplantation
In the follow-up periode mortality rate in both groups is registered
Time frame: Through study completion, and until 1 year after study start
Number of patients who relapsed the first year after transplantation Number of patients who relapsed the first year after transplantation Number of patients who relapsed the first year after transplantation
In the follow-up periode relapse rate in both groups is registered
Time frame: Through study completion, and until 1 year after study start
Quality of life (QoL) the first year after transplantation
In the follow-up periode EORTC-QLQ-C30 scores in both groups are registered
Time frame: Through study completion, and until 1 year after study start
Assessment of vitamin A derivatives
Measurement of retinoids and carotenoids in plasma before and after ECP treatment
Time frame: From randomization to 3 months after transplantation
Determination of microbiota
Assaying fecal microbiota from both study groups.
Time frame: Through study completion, and until 1 year after study start
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital