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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03139604
Registration number
NCT03139604
Ethics application status
Date submitted
2/05/2017
Date registered
4/05/2017
Date last updated
11/08/2021
Titles & IDs
Public title
GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
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Scientific title
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
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Secondary ID [1]
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INCB 39110-301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Graft-versus-host Disease (GVHD)
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Itacitinib
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone
Treatment: Drugs - Methylprednisolone
Experimental: Itacitinib - Itacitinib plus corticosteroids
Placebo Comparator: Placebo - Matching placebo plus corticosteroids
Treatment: Drugs: Itacitinib
Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
Treatment: Drugs: Placebo
Matching placebo tablets administered orally once daily (QD) plus corticosteroids.
Treatment: Drugs: Prednisone
Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.
Treatment: Drugs: Methylprednisolone
Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index
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Assessment method [1]
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Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
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Timepoint [1]
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Day 28
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Secondary outcome [1]
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Nonrelapse Mortality
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Assessment method [1]
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Defined as the percentage of participants who died due to causes other than malignancy relapse.
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Timepoint [1]
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Month 6,9,12 and 24
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Defined as the interval from first response until GVHD progression or death.
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Timepoint [2]
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Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months
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Secondary outcome [3]
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Cmax of Itacitinib When Administered in Combination With Corticosteroids
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Assessment method [3]
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Defined as maximum observed plasma concentration.
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Timepoint [3]
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Protocol-defined timepoints up to Day 28
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Secondary outcome [4]
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Cmin of Itacitinib When Administered in Combination With Corticosteroids
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Assessment method [4]
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Defined as minimum observed plasma concentration.
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Timepoint [4]
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Protocol-defined timepoints up to Day 28
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Secondary outcome [5]
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Tmax of Itacitinib When Administered in Combination With Corticosteroids
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Assessment method [5]
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Defined as time to maximum plasma concentration.
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Timepoint [5]
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Protocol-defined timepoints up to Day 28
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Secondary outcome [6]
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AUC of Itacitinib When Administered in Combination With Corticosteroids
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Assessment method [6]
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Defined as area under the concentration-time curve.
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Timepoint [6]
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Protocol-defined timepoints up to Day 28
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Secondary outcome [7]
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CL/F of Itacitinib When Administered in Combination With Corticosteroids
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Assessment method [7]
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Defined as oral dose clearance.
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Timepoint [7]
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Protocol-defined timepoints up to Day 28
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Secondary outcome [8]
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Time to Response
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Assessment method [8]
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Defined as the interval from treatment initiation to first response
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Timepoint [8]
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End of Study, total particpation expected to average 24 months
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Secondary outcome [9]
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Relapse Rate of Malignant and Nonmalignant Hematologic Disease
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Assessment method [9]
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Defined as the proportion of subjects whose underlying hematologic disease relapses
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Timepoint [9]
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Randomization through end of Study, study duration expected to average 24 months
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Secondary outcome [10]
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Malignancy Relapse-related Mortality Rate
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Assessment method [10]
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Defined as the proportion of subjects whose malignancy relapses and has a fatal outcome.
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Timepoint [10]
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Randomization through end of Study, study duration expected to average 24 months
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Secondary outcome [11]
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Failure-free Survival
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Assessment method [11]
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Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD)
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Timepoint [11]
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6 months from randomization
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Secondary outcome [12]
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Overall Survival (OS)
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Assessment method [12]
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Defined as the interval from study enrollment to death due to any cause.
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Timepoint [12]
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End of Study up to approximately 24 months
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Secondary outcome [13]
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Number of Treatment-emergent Adverse Events With INCB39110
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Assessment method [13]
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Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment
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Timepoint [13]
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30-35 days after end of treatment, approximately 24 months
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Secondary outcome [14]
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Incidence Rate of Secondary Graft Failure
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Assessment method [14]
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Defined as > 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (< 0.5 × 109/L) and/or thrombocytopenia (< 20 × 109/L) within 2 months of transplantion
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Timepoint [14]
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Randomization through end of Study, study duration expected to average 24 months
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Secondary outcome [15]
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Proportion of Subjects Who Discontinue Corticosteroids
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Assessment method [15]
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Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated
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Timepoint [15]
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Days 28, 56, 100, and 180
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Secondary outcome [16]
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Proportion of Subjects Who Discontinue Immunosuppressive Medications
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Assessment method [16]
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Summary statistics of subjects discontinuing immunosuppressive medications will be calculated
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Timepoint [16]
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Days 56 and 100
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Secondary outcome [17]
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Incidence Rate of aGVHD Flares
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Assessment method [17]
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Timepoint [17]
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up to day 100
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Secondary outcome [18]
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Incidence Rate of cGVHD
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Assessment method [18]
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0
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Timepoint [18]
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Days 180 and 365
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Secondary outcome [19]
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Objective Response Rate
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Assessment method [19]
0
0
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Timepoint [19]
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Days 14, 56 and 100
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/07/2020
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Sample size
Target
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Accrual to date
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Final
439
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St Vincents Hospital Sydney Limited - Darlinghurst
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Recruitment postcode(s) [1]
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NSW 2010 - Darlinghurst
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Recruitment outside Australia
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California
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Colorado
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Italy
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Italy
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Reggio Calabria
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Italy
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Seoul
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Valencia
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Basel
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Switzerland
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Geneve
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Zuerich
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Taiwan
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Taichung
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United Kingdom
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Cambridge
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United Kingdom
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Cardiff
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United Kingdom
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London
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United Kingdom
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Incyte Corporation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03139604
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Rodica Morariu-Zamfir, MD
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Incyte Corporation
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03139604
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