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

NCT03124056 | Completed DMC FDA Device

• 1 other identifier: 12/225
• Study Type: observational
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of the study:

1. 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. 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

Conditions

Graft-versus-host Disease

Keywords

Extracorporeal photopheresis; Biomarker of response; Steroid resistant

Outcome Measures

Primary Outcomes (1)

• Graft versus host disease Response

  Rate of clinical partial and complete response of acute and chronic Graft versus host disease to the intervention

  2 years

Secondary Outcomes (2)

• To determine rate of moderate and severe toxicity associated to extracorporeal photopheresis

  2 years

• To identify biomarkers associated with clinical response to extracorporeal photopheresis

  2 years

Interventions

Extracorporeal photopheresis DEVICE

Extracorporeal photopheresis using non-open system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute or chronic graft-versus-host disease resistant or dependent to corticosteroids after Allogeneic hematopoietic stem cell transplantation whatever be the cell source (blood, bone marrow or cord blood), diagnosed and treated in one of the participant centers

You may qualify if:

• 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.
• 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

You may not qualify if:

• uncontrolled Infections
• Performance score \<3
• Lack of adequate vascular access

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Photopheresis

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Carlos Solano, MD, PhD

  Hospital Clinico of Valencia, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 21, 2017
• Study Start: January 10, 2013
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: April 21, 2017

Record last verified: 2017-04