CompletedNot Applicable

Clinical and Biomarker Study of the Efficacy of Extracorporeal Photopheresis in Graft-versus-host Disease

62 participantsStarted 2013-01-10

Plain-language summary

The aims of the study: 1. 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). 2. 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Graft versus host disease Response

Timeframe: 2 years

Trial details

NCT IDNCT03124056

SponsorFundación para la Investigación del Hospital Clínico de Valencia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-02-28

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