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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
Sponsor:
Information provided by (Responsible Party):
Fundación para la Investigación del Hospital Clínico de Valencia

Study Description
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Brief 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

Condition or disease Intervention/treatment
Graft-versus-host Disease Device: Extracorporeal photopheresis

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Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Extracorporeal photopheresis
    Extracorporeal photopheresis using non-open system

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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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
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
Criteria

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:

  1. Refractory to corticosteroids: progression after 3-4 days of standard first line treatment with calcineurin inhibitor and glucocorticoids or no response after 7 days.
  2. 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.
  3. 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.
  4. 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
    • Disease progression after 2-3 weeks of treatment

Exclusion Criteria:

  • uncontrolled Infections
  • Performance score <3
  • Lack of adequate vascular access
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Fundación para la Investigación del Hospital Clínico de Valencia
Investigators
Principal Investigator: Carlos Solano, MD, PhD Hospital Clinico of Valencia, Spain
More Information
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Responsible Party: Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier: NCT03124056     History of Changes
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Fundación para la Investigación del Hospital Clínico de Valencia:
Extracorporeal photopheresis
Biomarker of response
Steroid resistant

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases