Back to resultsStudy of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD
Primary Purpose
Graft-versus-host Disease (GVHD)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Itacitinib (200 mg)
Itacitinib (300 mg)
prednisone or methylprednisolone (corticosteroids)
Sponsored by
About this trial
This is an interventional treatment trial for Graft-versus-host Disease (GVHD) focused on measuring Acute Graft Versus Host Disease
Eligibility Criteria
Inclusion Criteria:
- Have undergone first allo-HSCT from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative transplants are eligible.
- 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 received more than 1 hematopoietic stem cell transplantation.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Itacitinib (200 mg)
Itacitinib (300 mg)
Arm Description
Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids)
Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids)
Outcomes
Primary Outcome Measures
Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events
Secondary Outcome Measures
Overall Response Rate (ORR)
Maximum Observed Plasma Concentration (Cmax) of the two treatment groups Itacitinib
Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups Itacitinib
Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups Itacitinib
Minimum observed plasma concentration (Cmin) of the two treatment groups Itacitinib
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02614612
Brief Title
Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD
Official Title
A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-versus-host Disease (GVHD)
Keywords
Acute Graft Versus Host Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Itacitinib (200 mg)
Arm Type
Experimental
Arm Description
Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids)
Arm Title
Itacitinib (300 mg)
Arm Type
Experimental
Arm Description
Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids)
Intervention Type
Drug
Intervention Name(s)
Itacitinib (200 mg)
Other Intervention Name(s)
INCB039110
Intervention Type
Drug
Intervention Name(s)
Itacitinib (300 mg)
Other Intervention Name(s)
INCB039110
Intervention Type
Drug
Intervention Name(s)
prednisone or methylprednisolone (corticosteroids)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events
Time Frame
First dose of study drug to 30 days after the last dose of study drug
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Time Frame
Days 14, 28, 56 and 100
Title
Maximum Observed Plasma Concentration (Cmax) of the two treatment groups Itacitinib
Time Frame
Day 1 and Day 7
Title
Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups Itacitinib
Time Frame
Day 1 and Day 7
Title
Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups Itacitinib
Time Frame
Day 1 and Day 7
Title
Minimum observed plasma concentration (Cmin) of the two treatment groups Itacitinib
Time Frame
Day 1 and Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have undergone first allo-HSCT from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative transplants are eligible.
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 received more than 1 hematopoietic stem cell transplantation.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodica Morariu-Zamfir, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Duarte
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Coral Gables
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Kansas City
State/Province
Kansas
Country
United States
City
Westwood
State/Province
Kansas
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Hershey
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35689489
Citation
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.
Results Reference
derived
PubMed Identifier
32324888
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD
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