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Completed

NCT Number: NCT03204721

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

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.

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Key information

Conditions

Graft-Versus-Host Disease Graft vs Host Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tobias Gedde-Dhl

Oslo, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal photophoresis (ECP)

Other

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. Assessment of vitamin A derivatives

    Time frame: From randomization to 3 months after transplantation

    Measurement of retinoids and carotenoids in plasma before and after ECP treatment

  5. Determination of microbiota

    Time frame: Through study completion, and until 1 year after study start

    Assaying fecal microbiota from both study groups.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: GVHD

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2017
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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