Graft-Versus-Host Disease
Conditions
Brief summary
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.
Detailed description
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).
Interventions
OTHERExtracorporeal photophoresis (ECP)
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
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients admitted for allogeneic stamcelltransplantation who consent participation in the study are randomized 1:1, either to receive ECP or no-ECP
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
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 psoralens or citrate products * Splenectomy * Pregnancy/lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies | up to 1 year after allogeneic stamcell transplantation | GVHD is measured according to internationally recognized criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of survivors the first year after transplantation | Through study completion, and until 1 year after study start | In the follow-up periode mortality rate in both groups is registered |
| 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 | Through study completion, and until 1 year after study start | In the follow-up periode relapse rate in both groups is registered |
| Quality of life (QoL) the first year after transplantation | Through study completion, and until 1 year after study start | In the follow-up periode EORTC-QLQ-C30 scores in both groups are registered |
| Assessment of vitamin A derivatives | From randomization to 3 months after transplantation | Measurement of retinoids and carotenoids in plasma before and after ECP treatment |
| Determination of microbiota | Through study completion, and until 1 year after study start | Assaying fecal microbiota from both study groups. |
Countries
Norway
Outcome results
None listed