GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease



Status:Recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:1/30/2019
Start Date:January 31, 2018
End Date:January 2021
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease

The purpose of this study is to assess the impact and safety of itacitinib in combination
with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of
graft-versus-host-disease (GVHD).


Inclusion Criteria:

- Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no
circulating blasts and < 5% blasts in the bone marrow.

- Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic
leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell,
or mantle cell lymphoma must have chemosensitive disease at time of transplant.
Subjects with Hodgkin lymphoma with chemosensitive disease at the time of transplant.

- Must be candidates for reduced-intensity conditioning regimens.

- Must be candidates for peripheral blood stem cell transplants.

- Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group
Performance Status score of 0 to 2.

- Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or
calculated by Cockcroft-Gault equation.

- Be willing to avoid pregnancy or fathering children.

Exclusion Criteria:

- Has previously received an allogenic hematopoietic stem cell transplant.

- Presence of an active uncontrolled infection.

- Known HIV infection.

- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires
treatment or at risk for HBV reactivation.

- Prior malignancies.

- Severe organ dysfunction.

- Prior treatment with a JAK inhibitor or with an investigational agent, device, or
procedure within 21 days of enrollment.

- Currently breastfeeding.

- Known allergies, hypersensitivity, or intolerance to any of the study medications.

- Receipt of live (including attenuated) vaccines during the study, or anticipation of
need for such a vaccine during the study.

- History of primary idiopathic myelofibrosis or any severe marrow fibrosis that would
prolong neutrophil engraftment to > 28 days after transplant.
We found this trial at
14
sites
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Atlanta, GA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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1665 Aurora Court
Aurora, Colorado 80045
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Columbus, OH
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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Hackensack, New Jersey 07601
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LILLE Cedex,
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Los Angeles, CA
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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Milwaukee, WI
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Portland, OR
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Saint Louis, MO
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