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

Overview

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 Title of Study: “Prevention of Graft-versus-host Disease in Patients Treated With Allogeneic Stem Cell Transplantation: Possible Role of Extracorporeal Photophoresis”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: None (Open Label)
• Study Primary Completion Date: April 30, 2021

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

• Other: Extracorporeal 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

Arms, Groups and Cohorts

• Active Comparator: Extracorporeal photophoresis
  • 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.
• No Intervention: Controll
  • No procedure

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• Number of survivors the first year after transplantation
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: Through study completion, and until 1 year after study start
  • In the follow-up periode EORTC-QLQ-C30 scores in both groups are registered

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Oslo University Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Tobias Gedde-Dahl d.y., Consultant hematologist MD,PhD – Oslo University Hospital
• Overall Official(s)
  • Geir E Tjønnfjord, Prof,MD,PhD, Study Chair, Oslo University Hospital HF, Department of Haematology Rikshospitalet
  • Per Ole Iversen, Prof,MD,PhD, Study Chair, Oslo University Hospital HF, Department of Haematology Rikshospitalet