Graft-versus-host DiseaseBIOECP_GVHDNCT03124056
Clinical and Biomarker Study of the Efficacy of Extracorporeal Photopheresis in Graft-versus-host Disease
An observational study of Graft-versus-host Disease, run by Fundación para la Investigación del Hospital Clínico de Valencia.
Trial 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. 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 photopheresis
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2013to 28 Feb 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
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
Who may be able to join
- 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.
Show all 16Show fewer
- 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
Who cannot join
- uncontrolled Infections
- Performance score <3
- Lack of adequate vascular access
About this study
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
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
Read the detailed description
Title: Exploratory study of biomarkers associated with clinical response to extracorporeal photopheresis in the treatment of acute and chronic graft-versus-host disease post allogeneic hematopoietic stem cell transplantation
Objectives:
- To evaluate the clinical efficacy of the use of extracorporeal photopheresis in the treatment of acute or chronic Graft-versus-host disease under standard clinical indications as pre-defined by the participants Centers (Spanish Group for Hematopoietic Transplantation).
- To explore and identify biomarkers of clinical response to extracorporeal photopheresis by means of a comprehensive analysis of different immune populations including T, B and Natural Killer cells, prior to and within the episodes of clinical graft-versus-host disease and the kinetic profile of plasma cytokines (Interferon-gamma, B cell activating factor, Tumor Necrosis Factor-alfa and Interleukin-6) in relation with Graft-versus-host disease .
Methods:
50 patients with acute or chronic graft-versus-host disease 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 with closed extracorporeal photopheresis in the indications detailed bellow, will be analyzed in order to identify potential biomarkers of Graft versus host disease-response. Analyses of T, B and Natural Killer populations will be performed by Intracellular Cytokine Staining and Flow Cytometry. Cytokine measurement in plasma will be performed by Enzyme-Linked ImmunoSorbent Assay. Participants Centers:
- Hospital Clinico. Valencia. Spain
- Hospital Clinico. Salamanca. Spain
- Hospital Ramon y Cajal. Madrid. Spain.
- Hospital Murcia. Spain
- Hospital de Navarra, Pamplona. Spain
Each Centre will obtain approval of the study by the Local Ethical Committee and patients will sing inform consent. No risks are expected of the participation of the patients in this exploratory analytical study.
Frequency of treatment The frequency of treatment will depend on the type of Graft-versus-host disease (acute or chronic) and will be modified depending on the clinical response. All samples will be obtain at the same time that other standard blood samples.
Acute graft versus host disease: treatment will be initiated using 3 sessions/week, 1st week. Usually response will be determined in 3-4 weeks. If clear progression after 2 weeks of treatment or no response after 6-8 weeks treatment will be withhold and additional treatment will depend on the investigator decision. If response, the frequency of treatment will be reduced according to the following schedule:
- 2 treatments every week from week 2 to week 12
- 1 treatment every 2 weeks from week 13, until total suppression of corticosteroid treatment.
Response evaluation:
- Complete remission: resolution of all signs of Graft-versus-host disease
- Partial remission: improvement in at least 1 grade.
- Absence of response
Chronic Graft-versus-host disease : treatment will be initiated using 3 sessions during week 1, 2 sessions every 2 weeks during weeks 2 to 12. If no progression, first evaluation will be done at 3 months (week 12). If no response, extracorporeal photopheresis will be withhold, except for sclerodermiform graft versus host disease in which evaluation will be done at 6 months. If response on week 12: 2 sessions every month for 3 additional months, after suppression of corticosteroid treatment. Use of NIH Consensus Group criteria of response (2006)
Biomarkers study: Samples: 2 x 10 ml whole blood in ethylenediaminetetraacetate. will be obtain in each time point analysis: pre-extracorporeal photopheresis and on days +7, +14, +21, +30 post-extracorporeal photopheresis in acute GVHD and pre-extracorporeal photopheresis and on days +15, +30, +45, +60, +75, +90 post-extracorporeal photopheresis in chronic Graft versus host disease. Samples will be processed in each participant Center in order to obtain mononuclear cells following the attached protocol and stored freezed until transportation to the Centralized processing Laboratory at the Hospital Clinico, Valencia, Spain and sending the clinical information included in the attached Excel Database.
- Analyses of T, B and Natural Killer populations including Treg cells and dendritic cells Will be performed by Intracellular Cytokine Staining and Flow Cytometry (BD and Bioscience). Cell-populations and time-point to be monitored: pre-extracorporeal photopheresis and on days +7, +14, +21, +30 post-extracorporeal photopheresis in acute Graft versus host disease and pre-extracorporeal photopheresis and on days +15, +30, +45, +60, +75, +90 post-extracorporeal photopheresis in chronic Graft versus host disease.
- Cytokine measurement in plasma (Interferon-gamma, Tumor Necrosis Factor-alfa, Interleukin-10, B cell activating factor and Interleukin-6)
- Conditions
- Graft-versus-host Disease
- Being tested
- Extracorporeal photopheresis
- Keywords
- Extracorporeal photopheresis, Biomarker of response, Steroid resistant
- 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 photopheresisDevice
Extracorporeal photopheresis using non-open system
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft versus host disease Response
Rate of clinical partial and complete response of acute and chronic Graft versus host disease to the intervention
Measured: 2 years
Secondary outcomes (2)
To determine rate of moderate and severe toxicity associated to extracorporeal photopheresis
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline
Measured: 2 years
To identify biomarkers associated with clinical response to extracorporeal photopheresis
Association between levels of peripheral blood lymphocyte populations or serum cytokines and Clinical response
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start10 Jan 2013
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-versus-host DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Solano, MD, PhD, Principal investigator, Hospital Clinico of Valencia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124056
- Sponsor's protocol ID
- 12/225
- Acronym
- BIOECP_GVHD
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03124056
- Acronym / sponsor ID
- BIOECP_GVHD / 12/225
- Conditions
- Graft-versus-host Disease
- Keywords
- Extracorporeal photopheresis, Biomarker of response, Steroid resistant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 10 Jan 2013 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 21 Apr 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 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
Detailed description
Title: Exploratory study of biomarkers associated with clinical response to extracorporeal photopheresis in the treatment of acute and chronic graft-versus-host disease post allogeneic hematopoietic stem cell transplantation
Objectives:
- To evaluate the clinical efficacy of the use of extracorporeal photopheresis in the treatment of acute or chronic Graft-versus-host disease under standard clinical indications as pre-defined by the participants Centers (Spanish Group for Hematopoietic Transplantation).
- To explore and identify biomarkers of clinical response to extracorporeal photopheresis by means of a comprehensive analysis of different immune populations including T, B and Natural Killer cells, prior to and within the episodes of clinical graft-versus-host disease and the kinetic profile of plasma cytokines (Interferon-gamma, B cell activating factor, Tumor Necrosis Factor-alfa and Interleukin-6) in relation with Graft-versus-host disease .
Methods:
50 patients with acute or chronic graft-versus-host disease 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 with closed extracorporeal photopheresis in the indications detailed bellow, will be analyzed in order to identify potential biomarkers of Graft versus host disease-response. Analyses of T, B and Natural Killer populations will be performed by Intracellular Cytokine Staining and Flow Cytometry. Cytokine measurement in plasma will be performed by Enzyme-Linked ImmunoSorbent Assay. Participants Centers:
- Hospital Clinico. Valencia. Spain
- Hospital Clinico. Salamanca. Spain
- Hospital Ramon y Cajal. Madrid. Spain.
- Hospital Murcia. Spain
- Hospital de Navarra, Pamplona. Spain
Each Centre will obtain approval of the study by the Local Ethical Committee and patients will sing inform consent. No risks are expected of the participation of the patients in this exploratory analytical study.
Frequency of treatment The frequency of treatment will depend on the type of Graft-versus-host disease (acute or chronic) and will be modified depending on the clinical response. All samples will be obtain at the same time that other standard blood samples.
Acute graft versus host disease: treatment will be initiated using 3 sessions/week, 1st week. Usually response will be determined in 3-4 weeks. If clear progression after 2 weeks of treatment or no response after 6-8 weeks treatment will be withhold and additional treatment will depend on the investigator decision. If response, the frequency of treatment will be reduced according to the following schedule:
- 2 treatments every week from week 2 to week 12
- 1 treatment every 2 weeks from week 13, until total suppression of corticosteroid treatment.
Response evaluation:
- Complete remission: resolution of all signs of Graft-versus-host disease
- Partial remission: improvement in at least 1 grade.
- Absence of response
Chronic Graft-versus-host disease : treatment will be initiated using 3 sessions during week 1, 2 sessions every 2 weeks during weeks 2 to 12. If no progression, first evaluation will be done at 3 months (week 12). If no response, extracorporeal photopheresis will be withhold, except for sclerodermiform graft versus host disease in which evaluation will be done at 6 months. If response on week 12: 2 sessions every month for 3 additional months, after suppression of corticosteroid treatment. Use of NIH Consensus Group criteria of response (2006)
Biomarkers study: Samples: 2 x 10 ml whole blood in ethylenediaminetetraacetate. will be obtain in each time point analysis: pre-extracorporeal photopheresis and on days +7, +14, +21, +30 post-extracorporeal photopheresis in acute GVHD and pre-extracorporeal photopheresis and on days +15, +30, +45, +60, +75, +90 post-extracorporeal photopheresis in chronic Graft versus host disease. Samples will be processed in each participant Center in order to obtain mononuclear cells following the attached protocol and stored freezed until transportation to the Centralized processing Laboratory at the Hospital Clinico, Valencia, Spain and sending the clinical information included in the attached Excel Database.
- Analyses of T, B and Natural Killer populations including Treg cells and dendritic cells Will be performed by Intracellular Cytokine Staining and Flow Cytometry (BD and Bioscience). Cell-populations and time-point to be monitored: pre-extracorporeal photopheresis and on days +7, +14, +21, +30 post-extracorporeal photopheresis in acute Graft versus host disease and pre-extracorporeal photopheresis and on days +15, +30, +45, +60, +75, +90 post-extracorporeal photopheresis in chronic Graft versus host disease.
- Cytokine measurement in plasma (Interferon-gamma, Tumor Necrosis Factor-alfa, Interleukin-10, B cell activating factor and Interleukin-6)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- uncontrolled Infections
- Performance score <3
- Lack of adequate vascular access
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 photopheresisExtracorporeal photopheresis using non-open system | Device | – |
Primary outcome
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
2 secondary outcomes
To determine rate of moderate and severe toxicity associated to extracorporeal photopheresis
Time frame: 2 years
To identify biomarkers associated with clinical response to extracorporeal photopheresis
Time frame: 2 years
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 21 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Graft vs Host Disease
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.
Carlos Solano, MD, PhD principal investigator
Hospital Clinico of Valencia, Spain
Questions about this trial
What is this clinical trial studying?
An observational study of Graft-versus-host Disease, run by Fundación para la Investigación del Hospital Clínico de Valencia.
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 16 inclusion and 3 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Graft versus host disease Response (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2017.