Clinical trial NCT03204721: Prevention of GVHD in Patients Treated With Allogeneic SCT: Possible Role of Extracorporeal Photophoresis
Official title: Prevention of Graft-versus-host Disease in Patients Treated With Allogeneic Stem Cell Transplantation: Possible Role of Extracorporeal Photophoresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft-Versus-Host Disease
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies
timeFrame: up to 1 year after allogeneic stamcell transplantation
Secondary outcomes:
measure: Number of survivors the first year after transplantation
timeFrame: Through study completion, and until 1 year after study start
measure: 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
timeFrame: Through study completion, and until 1 year after study start
measure: Quality of life (QoL) the first year after transplantation
timeFrame: Through study completion, and until 1 year after study start
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Tobias Gedde-Dhl
Study officials:
affiliation: Oslo University Hospital HF, Department of Haematology Rikshospitalet
name: Geir E Tjønnfjord, Prof,MD,PhD
role: STUDY_CHAIR
affiliation: Oslo University Hospital HF, Department of Haematology Rikshospitalet
name: Per Ole Iversen, Prof,MD,PhD
role: STUDY_CHAIR
References: