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Trial record 1 of 1 for:    NCT04291261
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Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease

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ClinicalTrials.gov Identifier: NCT04291261
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : October 5, 2021
Sponsor:
Collaborators:
Mallinckrodt
University Medical Center Regensburg
Clinical Trial Center North (CTC North GmbH & Co. KG)
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
This is a single arm phase 2 trial which includes patients with high risk acute GVHD defined as Ann Arbor score 2 or 3. The purpose of the study is to improve the outcome of these patients in terms of response to treatment and treatment related mortality. All patients will receive the study intervention (ECP with Uvadex). The study hypothesis is that the treatment plan will produce a day 28 complete response rate higher than or equal to 52%, which will represent an improvement of 15% compared with the standard of care (37%). The rate of complete response to standard of care treatment is based on observed data in similar patients treated within the Mount Sanai Acute GVHD International Consorium (MAGIC). Patients will be treated for 56 days and followed for one year to also enable evaluation of long term outcome.

Condition or disease Intervention/treatment Phase
Acute-graft-versus-host Disease Drug: Uvadex Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicenter Study of Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease
Actual Study Start Date : March 11, 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
Extracorporeal photopheresis (ECP) with Uvadex
Patients in this single Arm study all receive the intervention consisting of ECP with Uvadex plus the standard of care treatment which consists of systemic corticosteroids 2mg/kg. Response to treatment will be evaluated on day 28. Patients will receive study treatment till day 56 and thereafter be followed until 1 year.
Drug: Uvadex
Extracorporeal photopheresis (ECP) with Uvadex is scheduled 3x/week in weeks 1+2, 2x/week thereafter till day 28 and 1x/week till day 56




Primary Outcome Measures :
  1. The proportion of complete response CR (that is, per-cent of patients with skin, liver, and GI GvHD all stage 0) at day 28 of study treatment. [ Time Frame: day 28 ]

Secondary Outcome Measures :
  1. Overall survival alloSCTchronolog Gesamtsumme 0_Overall 1_Overall 2_Overall 3_Overall 4_Overall 1. 1762 763 406 365 181 47 2. 202 103 28 35 31 5 3. 12 7 3 1 1 Overall survival [ Time Frame: 1 year ]
  2. Cumulative incidence of NRM [ Time Frame: 6 months and at 1 year ]
  3. Overall response rate (complete response + partial response) [ Time Frame: day 28 and day 56 ]
  4. Cumulative incidence of treatment-refractory GvHD [ Time Frame: day 28 ]
  5. Cumulative incidence of severe GI GvHD (Grade 3 and 4) [ Time Frame: through study completion, an average of 1 year ]
  6. Time to discontinuation of steroid therapy [ Time Frame: Start to end of steroid treatment. Time to discontinuation of steroid treatment will be assessed from start of steroid treatment up to relapse of underlying disease, death from any cause or up to 12 months after start of treatment, whichever came first. ]
  7. Number of lines of GvHD therapy [ Time Frame: through study completion, an average of 1 year ]
    any additional systemic treatment for GVHD is considered a line of therapy

  8. Cumulative incidence of chronic GvHD [ Time Frame: through study completion, an average of 1 year ]
  9. Number of serious infections [ Time Frame: through study completion, an average of 1 year ]
    defined as grade 3 by the Blood and Marrow Transplant Clinical Trials Network



Information from the National Library of Medicine

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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:

  1. New onset high risk acute GvHD (Ann Arbor score 2/3 as defined in Appendix A) following allogeneic SCT. Any clinical severity in accordance with Glucksberg grade II-IV is eligible.
  2. Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood). Recipients of non-myeloablative and myeloablative transplants are eligible.
  3. No prior systemic treatment for acute GvHD except for a Maximum of 3 days of prednisone ≤2 mg/kg/day (or IV methylprednisolone equivalent). Topical skin steroid treatment and non-absorbable oral steroid treatment for GI GvHD are permissible.
  4. Age 18 years or older.
  5. Platelet count > 25.000 (including platelet support)
  6. Eastern Coorperative Oncology Group (ECOG) score of 0≤2
  7. Negative pregnancy test within 10 days before start of study if the patient is a woman of child-bearing Age
  8. Direct bilirubin must be <2 mg/dL unless the elevation is known to be due to Gilbert syndrome or aGvHD within 3 days of enrollment.
  9. ALT/SGPT and AST/SGOT must be <5 x the upper limit of the normal range within 3 days of enrollment.
  10. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol.
  11. Written informed consent from patient.
  12. Biopsy of acute GvHD target organ is strongly recommended but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not enroll within 5 days of Initiation of systemic steroid treatment for acute GvHD are not permitted to participate

Exclusion Criteria:

  1. Progressive or relapsed malignancy
  2. Uncontrolled active infection
  3. Patients with chronic GvHD
  4. History of or current diagnosis of progressive multifocal leukoencephalopathy (PML)
  5. Pregnant or nursing (lactating) women
  6. Use of other drugs for the treatment of acute GvHD apart from ongoing GvHD prophylaxis and corticosteroids
  7. Patients on dialysis
  8. Patients requiring ventilator support
  9. Evidence of known infection with human immunodeficiency virus (HIV) or active hepatitis B
  10. Investigational agent within 30 days of enrollment without approval from the Sponsor/ Investigator (PI). (Off-label use of medication is not considered investigational unless in context of a formal study)
  11. History of allergic reaction to 8-MOP
  12. Concomitant diagnosis of malignant melanoma or basal cell carcinoma
  13. Hypersensitivity or allergy to both heparin and citrate products (if hypersensitive or allergic only to one, exclusion does not apply)
  14. Inability to tolerate extracorporeal volume shifts associated with ECP
  15. Presence of aphakia
  16. History of splenectomy
  17. Leucocyte count > 25.000/μl
  18. Coagulopathy
  19. Known photosensitive disease like systemic lupus erythematosus, porphyrias or albinism

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): NCT04291261


Contacts
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Contact: Francis A. Ayuk, Prof. Dr. +49 (0) 40 7410-55250/58097 ayuketan@uke.de
Contact: Nicolaus Kröger,, Prof. Dr. +49 (0) 40 7410 554851 n.kroeger@uke.de

Locations
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Germany
University Hospital Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Wolf Rösler, Dr.       wolf.roesler@uk-erlangen.de   
Contact: Anna Brandt       Anna.Brandt@uk-erlangen.de   
Principal Investigator: Wolf Rösler, Dr.         
Sub-Investigator: Anna Brandt, Dr.         
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Francis Ayuketang Ayuk, Prof. Dr.         
Contact: Nicolaus Kröger, Prof. Dr.         
University Medical Center Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Matthias Edinger, Prof. Dr.       Matthias.Edinger@klinik.uni-regensburg.de   
Contact: Daniela Weber, PD Dr.       Daniela.Weber@klinik.uni-regensburg.de   
Principal Investigator: Matthias Edinger, Prof. Dr.         
Sub-Investigator: Daniela Weber, PD Dr.         
Sub-Investigator: Daniel Wolff, Prof. Dr.         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Mallinckrodt
University Medical Center Regensburg
Clinical Trial Center North (CTC North GmbH & Co. KG)
Investigators
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Principal Investigator: Francis A. Ayuk, Prof. Dr. University Medical Center Hamburg-Eppendorf, Department of Stem Cell Transplantation
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04291261    
Other Study ID Numbers: MAGIC-HR-ECP
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021

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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 Universitätsklinikum Hamburg-Eppendorf:
Acute-graft-versus-host Disease
Allogeneic Stem Cell Transplantation
Ann Arbor GvHD Scoring
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases