GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
Status: | Recruiting |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/27/2019 |
Start Date: | June 8, 2017 |
End Date: | March 2020 |
Contact: | Incyte Corporation Call Center (US) |
Email: | medinfo@incyte.com |
Phone: | 1.855.463.3463 |
GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease
The purpose of this study is to evaluate itacitinib or placebo in combination with
corticosteroids as first-line treatment of participants with Grade II to IV acute
graft-versus-host disease (aGVHD).
corticosteroids as first-line treatment of participants with Grade II to IV acute
graft-versus-host disease (aGVHD).
Inclusion Criteria:
- Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA
matching) and any donor source (bone marrow, peripheral blood stem cells, or cord
blood) for a hematologic malignancy or disorder. Recipients of myeloablative and
reduced-intensity conditioning regimens are eligible.
- Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after
allo-HSCT and any GVHD prophylaxis regimen.
- Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
- Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or
calculated by Cockroft Gault equation.
- Willing to avoid pregnancy or fathering children.
- Able to give written informed consent and comply with all study visits and procedures.
- Able to swallow and retain oral medication.
Exclusion Criteria:
- Has received more than 1 allo-HSCT.
- Has received more than 2 days of systemic corticosteroids for aGVHD.
- Presence of GVHD overlap syndrome.
- Presence of an active uncontrolled infection.
- Known human immunodeficiency virus infection.
- Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment
or at risk for HBV reactivation.
- Participants with evidence of relapsed primary disease, or participants who have been
treated for relapse after the allo-HSCT was performed.
- Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day
methylprednisolone (or prednisone equivalent) within 7 days of randomization.
- Severe organ dysfunction unrelated to underlying GVHD, including:
- Cholestatic disorders or unresolved veno-occlusive disease of the liver.
- Clinically significant or uncontrolled cardiac disease.
- Clinically significant respiratory disease that requires mechanical ventilation
support or 50% oxygen.
- Currently breast feeding.
- Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a
JAK inhibitor before allo-HSCT is permitted.
- Treatment with any other investigational agent, device, or procedure within 21 days
(or 5 half-lives, whichever is greater) of enrollment.
- Any medical complications or conditions that would, in the investigator's judgment,
interfere with full participation in the study, including administration of study drug
and attending required study visits; pose a significant risk to the participant; or
interfere with interpretation of study data.
- Known allergies, hypersensitivity, or intolerance to any of the study medications,
excipients, or similar compounds.
We found this trial at
59
sites
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185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-4894
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800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Phone: 617-636-2675
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Phone: 617-667-3064
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Phone: 773-702-2023
University of Chicago One of the world's premier academic and research institutions, the University of...
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4100 John R
Detroit, Michigan 48201
Detroit, Michigan 48201
800-527-6266
Phone: 313-576-8030
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000
Phone: 601-815-3074
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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University of Southern California The University of Southern California is one of the world’s leading...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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116th St and Broadway
New York, New York 10027
New York, New York 10027
(212) 854-1754
Phone: 212-305-6679
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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1665 Aurora Court
Aurora, Colorado 80045
Aurora, Colorado 80045
Phone: 720-848-2199
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22 S Greene St
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 328-8667
Phone: 410-328-8199
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-6450
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-5083
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2035 W Taylor St
Chicago, Illinois
Chicago, Illinois
(312) 996-4350
Phone: 312-355-4200
University of Illinois at Chicago A major research university in the heart of one of...
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234 Goodman Street
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Phone: 513-584-5725
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
Phone: 720-754-4898
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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1600 Southwest Archer Road
Gainesville, Florida 32610
Gainesville, Florida 32610
Phone: 352-273-6843
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535 Barnhill Drive
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Phone: 317-278-6455
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La Jolla, California 92093
Phone: 858-822-1921
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1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Phone: 603-650-4595
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Los Angeles, California 90095
Phone: 310-794-0242
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-327-2241
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 646-888-8570
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Park Ridge, Illinois 60068
Phone: 847-410-0667
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1020 Walnut St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-5769
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Phone: 412-647-8571
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200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-538-9812
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-747-3543
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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101 Nicolls Rd
Stony Brook, New York 11794
Stony Brook, New York 11794
(631) 444-4000
Phone: 631-638-0844
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Winston-Salem, North Carolina 27157
Phone: 336-713-6914
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Worcester, Massachusetts 01655
Phone: 774-455-4456
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