Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD
NCT ID: NCT02614612
Last Updated: 2019-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2015-12-31
2018-08-31
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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Itacitinib (200 mg)
Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids)
Itacitinib (200 mg)
prednisone or methylprednisolone (corticosteroids)
All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56.
Itacitinib (300 mg)
Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids)
Itacitinib (300 mg)
prednisone or methylprednisolone (corticosteroids)
All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56.
Interventions
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Itacitinib (200 mg)
Itacitinib (300 mg)
prednisone or methylprednisolone (corticosteroids)
All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically suspected Grades IIB to IVD acute GVHD as per modified MN-CIBMTR criteria, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.
* Subjects may, but are not required to, have previously received corticosteroids for acute GVHD:
* Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
Exclusion Criteria
* Has progressed on more than 2 prior treatment regimens for acute GVHD.
* Presence of an active uncontrolled infection.
* Subjects with relapsed primary disease, or subjects who have been treated for relapse after the allogeneic hematopoietic stem-cell transplantation (allo-HSCT) was performed.
* Inadequate recovery from toxicity and/or complications from the prior allo-HSCT.
* Any corticosteroid therapy (for indications other than GVHD) at doses \> 1 mg/kg per day methylprednisolone or equivalent within 7 days of randomization.
* Previously received JAK inhibitor therapy for any indication.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Rodica Morariu-Zamfir, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Duarte, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Coral Gables, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Westwood, Kansas, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Countries
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References
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Pratta M, Paczesny S, Socie G, Barkey N, Liu H, Owens S, Arbushites MC, Schroeder MA, Howell MD. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease. Br J Haematol. 2022 Aug;198(4):729-739. doi: 10.1111/bjh.18300. Epub 2022 Jun 11.
Schroeder MA, Khoury HJ, Jagasia M, Ali H, Schiller GJ, Staser K, Choi J, Gehrs L, Arbushites MC, Yan Y, Langmuir P, Srinivas N, Pratta M, Perales MA, Chen YB, Meyers G, DiPersio JF. A phase 1 trial of itacitinib, a selective JAK1 inhibitor, in patients with acute graft-versus-host disease. Blood Adv. 2020 Apr 28;4(8):1656-1669. doi: 10.1182/bloodadvances.2019001043.
Other Identifiers
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INCB 39110-108
Identifier Type: -
Identifier Source: org_study_id
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