Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)
NCT ID: NCT02701634
Last Updated: 2018-12-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
66 participants
INTERVENTIONAL
2016-05-27
2018-03-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ENTO
ENTO 400 mg or 200 mg tablet twice daily for 48 weeks
ENTO
Tablets administered orally
Placebo
Placebo to match tablet twice daily for 48 weeks
Placebo
Tablets administered orally
Interventions
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ENTO
Tablets administered orally
Placebo
Tablets administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or non-pregnant, non-lactating, females
* Newly diagnosed cGVHD defined by:
* At least 100 days after receiving any allogeneic hematopoietic stem cell transplant AND
* Receiving a new course of systemic corticosteroids (≥ 0.5 mg/kg/day) as first-line cGVHD therapy at least 1 day and no more than 21 days prior to first dose of ENTO/Placebo AND
* Moderate to severe cGVHD as assessed by NIH cGVHD Diagnosis and Staging Criteria (NCDSC) with at least three organ systems involved OR one organ system with a score of 2 OR lung organ score = 1
* Individuals who have undergone transplant for hematologic malignancy are required to be in complete remission.
* Have either a normal ECG or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the Sponsor
Exclusion Criteria
* Uncontrolled infection within 4 weeks prior to randomization
* History of the following therapies in the post-transplant period:
* B cell depleting biologic agents
* CD19 CAR-T cells based therapies
* BTK/SYK/JAK/PI3K inhibitors
* Phototherapy-unless administered for acute GVHD
* Treatment of cGVHD with anti-thymocyte globulins (ATG), or campath within 60 days of screening visit unless used for treatment of acute GVHD
* Severe organ dysfunction manifested during screening period:
* Requiring supplemental oxygen at more than 2 L/min
* Uncontrolled arrhythmia or heart failure
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Weill Cornell Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Taussig Cancer Institute
Cleveland, Ohio, United States
Ohio State University, Wexner Medical Center
Columbus, Ohio, United States
Vanderbilt University
Nashville, Tennessee, United States
Princess Margaret
Toronto, Ontario, Canada
Institut Paoli Calmettes
Marseille, , France
Hopital Saint Louis
Paris, , France
Institut Gustave Roussy
Villejuif, , France
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Klinikum der Universitaet Regensburg
Regensburg, , Germany
Pusan National University Hospital
Busan, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Kings College Hospital NHS Trust
London, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Other Identifiers
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2015-004572-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-406-1840
Identifier Type: -
Identifier Source: org_study_id