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A Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard II Acute Graft-versus-host Disease (PCE-aGVHD)

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ClinicalTrials.gov Identifier: NCT03605940
Recruitment Status : Not yet recruiting
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

Acute graft versus host-disease remains a major cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation. The incidence of grade II to IV acute GVHD ranges from 30 to 50% of the patients transplanted. Steroids remain the standard first line treatment for acute GVHD.

Prolonged exposure to steroids is associated to increased risk of infections and of osteoporosis, osteonecrosis and alteration of growth in children. Thus, reducing steroid exposure in order to reduce treatment-related morbidity is another important goal in the management of standard risk aGVHD.

Extracoporeal photopheresis (ECP) is active in controlling steroid refractory or dependent acute GVHD.

Hypothesis:

In this study, the team hypothesizes that addition of ECP to first line treatment with 2 mg/kg steroids of standard risk grade II aGVHD can reduce steroid exposure by increasing the probability of 6 month FFTF including absence of systemic steroids for chronic GVHD.


Condition or disease Intervention/treatment Phase
Acute-graft-versus-host Disease Combination Product: Methoxsalen + ECP device Drug: Corticosteroids Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard Risk Grade II Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2022


Arm Intervention/treatment
Experimental: Experimental group
corticosteroids + ECP
Combination Product: Methoxsalen + ECP device
2 sessions per week during 4 weeks and 1 session per week during 8 weeks

Drug: Corticosteroids
2 mg/kg/day

Active Comparator: Contrôl group
corticosteroids alone
Drug: Corticosteroids
2 mg/kg/day




Primary Outcome Measures :
  1. Probability of being free of treatment failure (probability of survival without relapse, additional line of treatment for aGVHD and systemic therapy for chronic GVHD) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. mean of the cumulative dose of steroids [ Time Frame: Month 1- Month 2 - Month 3 - Month 6 - Month 12 ]
  2. cumulative incidence rate of infections [ Time Frame: Month 6 - Month 12 ]
  3. cumulative incidence of thromboembolic complications [ Time Frame: Month 3 ]
  4. incidence of chronic GVHD [ Time Frame: Month 6 - Month 12 ]
  5. severity of chronic GVHD [ Time Frame: Month 6 - Month 12 ]
  6. incidence rate of non-relapse mortality [ Time Frame: Month 6 - Month 12 ]
  7. incidence of disease relapse [ Time Frame: Month 6 - Month 12 ]
  8. disease-free survival [ Time Frame: Month 6 - Month 12 ]
  9. overall survival [ Time Frame: Month 6 - Month 12 ]
  10. scores of health-related quality of life using the French validated FACT-BMT [ Time Frame: Month 3 - Month 6 - Month 12 ]
  11. Total T cells number [ Time Frame: Month 3 - Month 6 - Month 12 ]
  12. CD4 T cells number [ Time Frame: Month 3 - Month 6 - Month 12 ]
  13. CD8 T cells number [ Time Frame: Month 3 - Month 6 - Month 12 ]
  14. B cells number [ Time Frame: Month 3 - Month 6 - Month 12 ]
  15. NK cells number [ Time Frame: Month 3 - Month 6 - Month 12 ]
  16. gamma globulin number [ Time Frame: Month 3 - Month 6 - Month 12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years ;
  • Having received an allogeneic stem cell transplantation for any malignant or non-malignant hemopathy and whatever the type of donor and graft.
  • with grade II acute GVHD with skin involvement (stage 1-3 skin +/- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation
  • acute GVHD in the first line treatment
  • validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months. In the absence of a pre-existing and adpated central catheter at the time of inclusion, peripheral venous access will be preferred
  • Leucocytes > 1.5 G/L
  • Platelets > 30 G/L, Haematocrite > 27% (allowed transfusions)
  • Patient affiliated to a French Social Security regimen
  • information consent form signed.

Exclusion Criteria:

  • acute GVHD of grade I
  • acute GVHD of grade > II
  • progressive hematologic disease at inclusion
  • uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load.
  • patient with HIV positivity or replicative HBV or HCV infection
  • Contraindications for UVADEX / photopheresis / stéroids / posaconazole / heparin
  • Patient with a history of deep venous thrombosis
  • Pregnancy
  • Women of child bearing potentiel not using contaception

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): NCT03605940


Contacts
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Contact: Marie-Thérèse RUBIO, PU-PH 0383153282 m.rubio@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03605940    
Other Study ID Numbers: 2017-005162-22
PSS2017/PCE-aGVHD-RUBIO/VS ( Other Identifier: CHRU Nancy )
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Acute-graft-versus-host Disease
Extracorporal Photopheresis
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Methoxsalen
Photosensitizing Agents
Dermatologic Agents