- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03497273
Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
March 2, 2020 updated by: Incyte Corporation
An Open-Label Single-Arm Phase 1 Study Evaluating Safety of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
The purpose of this study is to assess the safety and tolerability of itacitinib in combination with corticosteroids in Japanese subjects with Grades II to IV acute graft-versus-host disease (aGVHD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aichi
-
Anjo-Shi, Aichi, Japan, 446-8602
- Ja-Aichi Anjo Kosei Hospital
-
Nagoya-Shi, Aichi, Japan, 466-8560
- Nagoya University Hospital
-
-
Hokkaido
-
Sapporo-Shi, Hokkaido, Japan, 003-0006
- Hokuyukai Sapporo Hokuyu Hospital
-
Sapporo-shi, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
-
-
Hyogo
-
Nishinomiya-Shi, Hyogo, Japan, 663-8501
- Hyogo College of Medicine Hospital
-
-
Ibaraki-Ken
-
Tsukuba-shi, Ibaraki-Ken, Japan, 305-8576
- University of Tsukuba Hospital
-
-
Kagoshima
-
Kagoshima-Shi, Kagoshima, Japan, 890-0064
- Jiaikai Imamura General Hospital
-
-
Kanagawa
-
Isehara-Shi, Kanagawa, Japan, 259-1193
- Tokai University Hospital
-
-
Kanagawa-Ken
-
Yokohama-shi, Kanagawa-Ken, Japan, 241-8515
- Kanagawa Cancer Center
-
-
Kumamoto-Ken
-
Kumamoto-shi, Kumamoto-Ken, Japan, 860-0008
- Nho Kumamoto Medical Center
-
-
Miyagi-Ken
-
Sendai-shi, Miyagi-Ken, Japan, 980-8574
- Tohoku University Hospital
-
-
Okayama-Ken
-
Okayama-shi, Okayama-Ken, Japan, 700-8558
- Okayama University Hospital
-
-
Osaka
-
Osaka-Shi, Osaka, Japan, 545-8586
- Osaka City University Hospital
-
-
Shizuoka-Ken
-
Nagaizumi-cho, Shizuoka-Ken, Japan, 411-8777
- Shizuoka Cancer Center
-
-
Tochigi-Ken
-
Shimotsuke-shi, Tochigi-Ken, Japan, 329-0498
- Jichi Medical University Hospital
-
-
Tokyo-To
-
Chuo Ku, Tokyo-To, Japan, 104-8560
- St. Luke's International Hospital
-
Minato-ku, Tokyo-To, Japan, 105-8471
- Jikei University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Japanese; subject was born in Japan and has not lived outside of Japan for a total of > 10 years, and subject can trace maternal and paternal Japanese ancestry.
- Has undergone 1 allo-hematopoietic stem cell transplant (HSCT) from any donor and source (unrelated, sibling, haploidentical donors with any matching) using bone marrow, peripheral blood or cord blood for hematologic malignancies. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
- Clinically suspected Grades II to IV aGVHD as per Mount Sinai Acute GVHD International Consortium (MAGIC) criteria, occurring after allo-HSCT and any anti-GVHD prophylactic medication.
- Evidence of myeloid engraftment (eg, absolute neutrophil count [ANC] ≥ 0.5 × 10^9/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed.
- Female subjects should agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration if of childbearing potential or must have evidence of non-childbearing potential by fulfilling protocol-defined criteria at screening.
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 (defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection; persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection).
- Known human immunodeficiency virus infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. For subjects with negative HBsAg and positive total hepatitis B core antibody and for subjects who are positive for HCV antibody, HBV DNA and HCV RNA must be undetectable upon testing.
- Evidence of relapsed primary disease or having been treated for relapse after the allo-HSCT was performed.
- Any corticosteroid therapy (for indication other than GVHD) at doses > 1 mg/kg per day methylprednisolone or equivalent within 7 days of enrollment.
Severe organ dysfunction unrelated to underlying GVHD, including the following:
- 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.
- Serum creatinine > 2.0 mg/dL or creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault equation
- Received Janus kinase (JAK) inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.
- Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Itacitinib + corticosteroids
Itacitinib administered in combination with corticosteroids.
|
Itacitinib administered orally once daily at the protocol-defined dose.
Other Names:
Either oral prednisolone or intravenous methylprednisolone at the investigator's discretion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of treatment-emergent adverse events
Time Frame: Up to approximately 12 months
|
Defined as any adverse event reported for the first time or worsening of a pre-existing event after first dose of study drug.
|
Up to approximately 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax of INCB039110
Time Frame: Up to approximately 1 month
|
Maximum observed plasma concentration.
|
Up to approximately 1 month
|
Cl/F of INCB039110
Time Frame: Up to approximately 1 month
|
Apparent oral dose clearance.
|
Up to approximately 1 month
|
Objective response rate
Time Frame: Up to 100 days
|
Defined as the proportion of participants demonstrating a complete response, very good partial response, or partial response.
|
Up to 100 days
|
Nonrelapse mortality
Time Frame: Up to approximately 12 months
|
Defined as the proportion of participants who died due to causes other than malignancy.
|
Up to approximately 12 months
|
Duration of response
Time Frame: Up to approximately 12 months
|
Defined as the interval from first response until GVHD progression or death.
|
Up to approximately 12 months
|
Time to response
Time Frame: Up to approximately 12 months
|
Defined as the interval from treatment initiation to first response.
|
Up to approximately 12 months
|
Malignancy relapse rate
Time Frame: Up to approximately 12 months
|
Defined as the proportion of participants whose underlying malignancy relapses.
|
Up to approximately 12 months
|
Failure-free survival
Time Frame: Up to 6 months
|
Defined as the proportion of participants who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic GVHD (cGVHD).
|
Up to 6 months
|
Overall survival
Time Frame: Up to approximately 12 months
|
Defined as the interval from study enrollment to death due to any cause.
|
Up to approximately 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2018
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
February 17, 2020
Study Registration Dates
First Submitted
April 6, 2018
First Submitted That Met QC Criteria
April 6, 2018
First Posted (Actual)
April 13, 2018
Study Record Updates
Last Update Posted (Actual)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INCB 39110-118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Graft-versus-host Disease
-
Mesoblast, Inc.Quintiles, Inc.CompletedGrade B Acute Graft Versus Host Disease | Grade C Acute Graft Versus Host Disease | Grade D Acute Graft Versus Host DiseaseUnited States
-
University of LiegeTerminatedChronic Graft-Versus-Host Disease | Acute Graft-Versus-Host Disease | Steroid Refractory Graft-Versus-Host DiseaseBelgium
-
Jazz PharmaceuticalsCompletedAcute-graft-versus-host Disease | Graft-versus-host DiseaseUnited States, Belgium, United Kingdom, Greece, Germany, Spain, France, Italy, Austria, Canada, Bulgaria, Croatia, Poland, Portugal
-
Jonsson Comprehensive Cancer CenterWithdrawnAcute Graft Versus Host Disease | Gastrointestinal Tract Acute Graft Versus Host Disease | Severe Gastrointestinal Tract Acute Graft Versus Host Disease | Steroid Resistant Gastrointestinal Tract Acute Graft Versus Host DiseaseUnited States
-
AltruBio Inc.CompletedSteroid-refractory Acute Graft-versus-Host Disease | Treatment-refractory Acute Graft-versus-Host DiseaseUnited States
-
Shenzhen Xbiome Biotech Co., Ltd.Beijing Improve-Quality Tech.Co., Ltd.Recruiting
-
Cytopeutics Sdn. Bhd.Universiti Tunku Abdul RahmanActive, not recruitingAcute-graft-versus-host DiseaseMalaysia
-
Incyte CorporationTerminatedAcute Graft-versus-host DiseaseUnited States, Spain, France, Italy, United Kingdom, Germany
-
Central Hospital, Nancy, FranceUnknown
-
MallinckrodtPRA Health SciencesTerminatedAcute Graft-versus-Host DiseaseUnited States, Canada, Germany, United Kingdom, Australia, Austria, Belgium, Italy, France, Netherlands, Switzerland
Clinical Trials on Itacitinib
-
Incyte CorporationCompletedRheumatoid ArthritisUnited States, Puerto Rico
-
Incyte CorporationActive, not recruitingB-cell MalignanciesUnited States
-
Assistance Publique - Hôpitaux de ParisRecruitingSystemic SclerosisFrance
-
Incyte CorporationTerminatedBronchiolitis Obliterans SyndromeUnited States, Belgium, Canada
-
Incyte CorporationCompletedPolycythemia Vera | Myelofibrosis | ThrombocythemiaSpain, United States, Germany, Austria, Belgium, Italy, Poland
-
Imperial College LondonIncyte Biosciences UK LtdActive, not recruitingAdvanced Hepatocellular CarcinomaUnited Kingdom
-
Incyte CorporationActive, not recruitingChronic Graft Versus Host Disease | Myelofibrosis | Postlung Transplant (Bronchiolitis Obliterans)United States, Spain, Italy, Germany, Belgium, Austria, Israel, Canada, Greece
-
Incyte CorporationAvailableSTAT1 Gain-of-Function Disease
-
John LevineCompletedGVHD | Low Risk Acute Graft-versus-host Disease | Graft-versus-host-diseaseUnited States
-
Incyte CorporationCompletedMPN (Myeloproliferative Neoplasms)Canada, United States, Australia