An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)
NCT ID: NCT03339297
Last Updated: 2021-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
152 participants
INTERVENTIONAL
2018-02-21
2020-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Defibrotide Prophylaxis
Standard of Care Immunoprophylaxis + Defibrotide
Defibrotide
6.25 mg/kg via 2-hour IV infusion every 6 hours
Standard of Care
Administered according to local institutional guidelines, physician preference, and patient need.
Standard of Care
Standard of Care Immunoprophylaxis Alone
Standard of Care
Administered according to local institutional guidelines, physician preference, and patient need.
Interventions
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Defibrotide
6.25 mg/kg via 2-hour IV infusion every 6 hours
Standard of Care
Administered according to local institutional guidelines, physician preference, and patient need.
Eligibility Criteria
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Inclusion Criteria
2. Participant must be diagnosed with acute leukemia in morphologic complete remission (CR1 or CR2) or with Myelodysplastic syndrome (MDS) with no circulating blasts and with less than 5% blasts in the bone marrow
3. Participant must have planned to receive either a myeloablative or reduced-intensity conditioning regimen and have an unrelated donor who is human leukocyte antigen (HLA) matched or single-allele mismatched
4. Participant must receive the following medical regimen as part of standard of care immunoprophylaxis for GvHD in either study arm at doses and regimen determined by local institutional guidelines, physician preference, and participant need:
Methotrexate (MTX) or Mycophenolate mofetil (MMF) + calcineurin inhibitor (Cyclosporine A \[CSA\] or Tacrolimus \[TAC\]) +/- Anti-thymocyte globulin (ATG) (ATG use is limited to 30% of participants).
5. Graft must be a CD3+ T-cell replete peripheral blood stem cell (PBSC) graft or non-manipulated bone marrow (BM) graft.
6. Adult participants must be able to understand and sign a written informed consent. For pediatric participants, the parent/legal guardian or representative must be able to understand and sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria
2. Participant is using or plans to use an investigational agent for the prevention of GvHD.
3. Participant is receiving or plans to receive other investigational therapy and/or is enrolled or plans to enroll in a separate clinical study.
4. Participant, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
5. Participant has a psychiatric illness that would prevent the participant or legal guardian or representative from giving informed consent and/or assent.
6. Participant has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study.
7. Participant is pregnant or lactating and does not agree to stop breastfeeding.
8. Any other condition that would cause a risk to the participant if he/she participated in the trial.
9. Participant has a known history of hypersensitivity to defibrotide or any of the excipients.
10. Participant had acute bleeding that is clinically significant within 24 hours before the start of study treatment, defined as either of the following:
* Hemorrhage requiring \>15 cc/kg of packed red blood cells (eg, pediatric participant weighing 20 kg and requiring 300 cc packed red blood cells/24 hours, or an adult weighing \>70 kg and requiring 3 units of packed red blood cells/24hours) to replace blood loss, or
* Bleeding from a site which, in the investigator's opinion, constituted a potential life-threatening source (eg, pulmonary hemorrhage or central nervous system bleeding), irrespective of amount of blood loss
11. Participant used any medication that increases the risk of bleeding within 24 hours before the start of study treatment, including, but not limited to, systemic heparin, low molecular weight heparin, heparin analogs, alteplase, streptokinase, urokinase, antithrombin III, oral anticoagulants including warfarin, and other agents that increase the risk of bleeding. Participants may have received heparin or other anticoagulants for routine central venous line management and intermittent dialysis or ultrafiltration. Fibrinolytic instillation for central venous line occlusion was also permitted. Note: Heparin used to keep catheters open was allowed (up to 100 U/kg/day).
1 Year
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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USC Norris Cancer Center
Los Angeles, California, United States
Mattel Children's Hospital UCLA
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, United States
Blood & Marrow Transplant Center
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Kansas Medical Center
Westwood, Kansas, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Montefiore Einstein Cancer Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
MUSC-Hollings Cancer Center
Charleston, South Carolina, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Universitätsklinikum Innsbruck
Innsbruck, , Austria
Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH
Linz, , Austria
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Specialized Hospital for Active Treatment of Haematological Diseases - Sofia
Sofia, , Bulgaria
Hôpital Maisonneuve-Rosemont
Montreal, , Canada
Sainte Justine Hospital
Montreal, , Canada
McGill University Health Center
Montreal, , Canada
Klinichki Bolnicki Centar Zagreb
Zagreb, , Croatia
Hospital d Instructions des Armees Percy
Clamart, , France
CHRU Lille
Lille, , France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Helios Klinikum Berlin Buch
Berlin, , Germany
Medizinische Universitätsklinik Knappschaftskrankenhaus
Bochum, , Germany
Klinikum Frankfurt (Oder) GmbH
Brandenburg, , Germany
Uniklinik Köln
Cologne, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
University Medicine Göttingen Germany
Göttingen, , Germany
Universitaetsklinikum Halle (Saale)
Halle, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Klinikum Mannheim Universitätsklinikum gGmbH
Mannheim, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Klinikum der Universitat Regensburg
Regensburg, , Germany
Attikon University General Hospital
Athens, , Greece
University General Hospital of Patras
Pátrai, , Greece
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Centrum Onkologii im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, , Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, , Portugal
Hospital Universitario Marques de Valdecilla
A Coruña, , Spain
Hospital de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, , Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
St. James University Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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References
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Hudspeth M, Mori S, Nachbaur D, Perez-Simon JA, Stolzel F, Riches M, Wu W, Zhang P, Agarwal S, Yakoub-Agha I. A phase II, prospective, randomized, open-label study of defibrotide added to standard-of-care prophylaxis for the prevention of acute graft-versus-host disease after allogeneic hematopoietic cell transplantation. Haematologica. 2023 Apr 1;108(4):1026-1038. doi: 10.3324/haematol.2022.281471.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JZP963-201
Identifier Type: -
Identifier Source: org_study_id
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