Prevention of Graft-versus-host Disease in Patients Treated With Allogeneic Stem Cell Transplantation: Possible Role of Extracorporeal Photophoresis
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oslo University Hospital
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies
Time Frame: up to 1 year after allogeneic stamcell transplantation
GVHD is measured according to internationally recognized criteria
Secondary Outcomes
- Number of survivors the first year after transplantation(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(Through study completion, and until 1 year after study start)
- Quality of life (QoL) the first year after transplantation(Through study completion, and until 1 year after study start)
- Assessment of vitamin A derivatives(From randomization to 3 months after transplantation)
- Determination of microbiota(Through study completion, and until 1 year after study start)
Investigators
Tobias Gedde-Dahl d.y.
Consultant hematologist MD,PhD
Oslo University Hospital