Prevention of GVHD in Patients Treated With Allogeneic SCT: Possible Role of Extracorporeal Photophoresis

University of Oslo (UIO)

Status: Completed

Conditions: Graft-Versus-Host Disease

Treatments: Other: Extracorporeal photophoresis (ECP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03204721

2016/1130

Details and patient eligibility

About

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.

Full 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).

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

158 participants in 2 patient groups

Extracorporeal photophoresis

Active Comparator group

Description:

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.

Treatment:

Other: Extracorporeal photophoresis (ECP)

Controll

No Intervention group

Description:

No procedure