Graft-Versus-Host DiseaseGVHDNCT03204721
Prevention of GVHD in Patients Treated With Allogeneic SCT: Possible Role of Extracorporeal Photophoresis
A study testing Extracorporeal photophoresis (ECP) in people with Graft-Versus-Host Disease, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft-Versus-Host Disease
- What is being tested?
- Extracorporeal photophoresis (ECP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteNorway
- Study dates
- 21 Jun 2017to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- (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 locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Graft-versus-host Disease in Patients Treated With Allogeneic Stem Cell Transplantation: 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.
Read the 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).
- Conditions
- Graft-Versus-Host Disease
- Being tested
- Extracorporeal photophoresis (ECP)
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal photophoresis | Active comparator | 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. Receives: Other: Extracorporeal photophoresis (ECP) |
| Controll | No intervention | No procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies
GVHD is measured according to internationally recognized criteria
Measured: up to 1 year after allogeneic stamcell transplantation
Secondary outcomes (5)
Number of survivors the first year after transplantation
In the follow-up periode mortality rate in both groups is registered
Measured: 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
In the follow-up periode relapse rate in both groups is registered
Measured: Through study completion, and until 1 year after study start
Quality of life (QoL) the first year after transplantation
In the follow-up periode EORTC-QLQ-C30 scores in both groups are registered
Measured: Through study completion, and until 1 year after study start
Assessment of vitamin A derivatives
Measurement of retinoids and carotenoids in plasma before and after ECP treatment
Measured: From randomization to 3 months after transplantation
Determination of microbiota
Assaying fecal microbiota from both study groups.
Measured: Through study completion, and until 1 year after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start21 Jun 2017
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients admitted for allogeneic stamcelltransplantation who consent participation in the study are randomized 1:1, either to receive ECP or no-ECP
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Gedde-Dahl d.y., Oslo University Hospital
- Investigators
- Geir E Tjønnfjord, Prof,MD,PhD, Study chair, Oslo University Hospital HF, Department of Haematology RikshospitaletPer Ole Iversen, Prof,MD,PhD, Study chair, Oslo University Hospital HF, Department of Haematology Rikshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204721
- Sponsor's protocol ID
- 2016/1130
- Acronym
- GVHD
- Status last verified
- Sep 2025
- First submitted
- 1 Jun 2017
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iversen PO, Ali MM, Bastani NE, Blomhoff R, Tjonnfjord GE, Gedde-Dahl T. Plasma Levels of Retinoids and Carotenoids in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation Given Extracorporeal Photopheresis to Prevent Graft-Versus-Host Disease-Analyses From a Randomized Trial. EJHaem. 2026 May 13;7(3):e70296. doi: 10.1002/jha2.70296. eCollection 2026 Jun.
PubMed 42137823
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Graft-versus-host Disease in Patients Treated With Allogeneic Stem Cell Transplantation: Possible Role of Extracorporeal Photophoresis
- ClinicalTrials.gov ID
- NCT03204721
- Acronym / sponsor ID
- GVHD / 2016/1130
- Conditions
- Graft-Versus-Host Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients admitted for allogeneic stamcelltransplantation who consent participation in the study are randomized 1:1, either to receive ECP or no-ECP
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal photophoresis | Active comparator | 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. |
| Controll | No intervention | –No procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- (in addition to those regarding eligibility for transplantation itself):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Extracorporeal photophoresis |
Primary outcome
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
5 secondary outcomes
Number of survivors the first year after transplantation
Time frame: 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
Time frame: Through study completion, and until 1 year after study start
Quality of life (QoL) the first year after transplantation
Time frame: Through study completion, and until 1 year after study start
Assessment of vitamin A derivatives
Time frame: From randomization to 3 months after transplantation
Determination of microbiota
Time frame: Through study completion, and until 1 year after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Derived from this study: PubMed 42137823Iversen PO, Ali MM, Bastani NE, Blomhoff R, Tjonnfjord GE, Gedde-Dahl T. Plasma Levels of Retinoids and Carotenoids in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation Given Extracorporeal Photopheresis to Prevent Graft-Versus-Host Disease-Analyses From a Randomized Trial. EJHaem. 2026 May 13;7(3):e70296. doi: 10.1002/jha2.70296. eCollection 2026 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal photophoresis (ECP) in people with Graft-Versus-Host Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03204721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.