Clinical and Biomarker Study of the Efficacy of Extracorporeal Photopheresis in Graft-versus-host Disease (BIOECP_GVHD)
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ClinicalTrials.gov Identifier: NCT03124056 |
Recruitment Status :
Completed
First Posted : April 21, 2017
Last Update Posted : April 21, 2017
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The aims of the study:
- To evaluate the clinical efficacy of the use of extracorporeal photopheresis in the treatment of Graft-versus-host disease under standard clinical indications as pre-defined by the participants Centers (members of the Spanish Group for Hematopoietic Transplantation).
- To explore and identify biomarkers of clinical response to extracorporeal photopheresis treatment of acute or chronic Graft-versus-host disease after Allogeneic hematopoietic stem cell transplantation
Condition or disease | Intervention/treatment |
---|---|
Graft-versus-host Disease | Device: Extracorporeal photopheresis |

Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 62 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | Clinical and Biological Study of the Efficacy of the Use of Closed Extracorporeal Photopheresis in Acute or Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Transplantation |
Actual Study Start Date : | January 10, 2013 |
Actual Primary Completion Date : | February 28, 2017 |
Actual Study Completion Date : | February 28, 2017 |

- Device: Extracorporeal photopheresis
Extracorporeal photopheresis using non-open system
- Graft versus host disease Response [ Time Frame: 2 years ]Rate of clinical partial and complete response of acute and chronic Graft versus host disease to the intervention
- To determine rate of moderate and severe toxicity associated to extracorporeal photopheresis [ Time Frame: 2 years ]Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline
- To identify biomarkers associated with clinical response to extracorporeal photopheresis [ Time Frame: 2 years ]Association between levels of peripheral blood lymphocyte populations or serum cytokines and Clinical response

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Patients with acute or chronic graft-versus-host disease resistant or dependent to corticosteroids after Allogeneic Hematopoietic transplantation whatever be the cell source (blood, bone marrow or cord blood), diagnosed and treated in one of the participant centers
- Definitions:
Acute Graft versus host disease:
- Refractory to corticosteroids: progression after 3-4 days of standard first line treatment with calcineurin inhibitor and glucocorticoids or no response after 7 days.
- Corticosteroids dependent: flare o evidence of progression of Graft versus host disease in the same or new affected organ after reduction of full dose (2 mg/Kg/día), that has been maintained for at least 2 weeks.
- Acute Graft versus host disease grade ≥ II, with response to 1st line treatment with cyclosporine A and prednisone in patients who present intolerable adverse effects that preclude to maintain this treatment as evaluated by the responsable physician.
- Patient with viral reactivation during acute Graft versus host disease that need reduction of immunosuppression as evaluated by the responsable physician.
Chronic Graft versus host disease: Muco-cutaneous or hepatic moderate or severe chronic Graft versus host disease (as defined by NIH Consensus Group criteria (Biol Blood Marrow Transplantation 2005;11:945), refractory to steroids (1 mg/Kg/day of methylprednisolone during 15-30 days) or steroid-dependent (requiring more than 10 mg/day of methylprednisolone to control manifestations).
First line
- Associated to corticosteroids if exists contraindication for calcineurin inhibitors.
- Associated to calcineurin inhibitors and corticosteroids in case of pulmonary chronic Graft versus host disease diagnosis (optional) Second line
- Progressive cutaneous moderate or severe chronic Graft versus host disease after acute Graft versus host disease that is being treated with calcineurin inhibitors and corticosteroids.
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Moderate or severe cutaneous (both lichenoid or sclerodermiform) o mucosal chronic Graft versus host disease refractory to corticosteroids:
- No Partial remission after 1 month of treatment
- No Complete remission after 3 months of treatment
- Disease progression after 2-3 weeks of treatment
Exclusion Criteria:
- uncontrolled Infections
- Performance score <3
- Lack of adequate vascular access

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124056
Principal Investigator: | Carlos Solano, MD, PhD | Hospital Clinico of Valencia, Spain |
Responsible Party: | Fundación para la Investigación del Hospital Clínico de Valencia |
ClinicalTrials.gov Identifier: | NCT03124056 |
Other Study ID Numbers: |
12/225 |
First Posted: | April 21, 2017 Key Record Dates |
Last Update Posted: | April 21, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Extracorporeal photopheresis Biomarker of response Steroid resistant |
Graft vs Host Disease Immune System Diseases |