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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal photophoresis | Active Comparator | 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. |
|
| Controll | No Intervention | No procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal photophoresis (ECP) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 1 year after allogeneic stamcell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of survivors the first year after transplantation | In the follow-up periode mortality rate in both groups is registered | 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 |
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Inclusion Criteria:
Exclusion Criteria:
(in addition to those regarding eligibility for transplantation itself):
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| Name | Affiliation | Role |
|---|---|---|
| Geir E Tjønnfjord, Prof,MD,PhD | Oslo University Hospital HF, Department of Haematology Rikshospitalet | Study Chair |
| Per Ole Iversen, Prof,MD,PhD | Oslo University Hospital HF, Department of Haematology Rikshospitalet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tobias Gedde-Dhl | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42137823 | Derived | Iversen PO, Ali MM, Bastani NE, Blomhoff R, Tjonnfjord GE, Gedde-Dahl T. Plasma Levels of Retinoids and Carotenoids in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation Given Extracorporeal Photopheresis to Prevent Graft-Versus-Host Disease-Analyses From a Randomized Trial. EJHaem. 2026 May 13;7:e70296. doi: 10.1002/jha2.70296. eCollection 2026 Jun. |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017893 | Photopheresis |
| ID | Term |
|---|---|
| D011701 | PUVA Therapy |
| D014467 | Ultraviolet Therapy |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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Patients admitted for allogeneic stamcelltransplantation who consent participation in the study are randomized 1:1, either to receive ECP or no-ECP
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|
In the follow-up periode relapse rate in both groups is registered |
| 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 | 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 | From randomization to 3 months after transplantation |
| Determination of microbiota | Assaying fecal microbiota from both study groups. | Through study completion, and until 1 year after study start |
| D005112 |
| Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |