Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD

Graft-versus-host Disease (GVHD) Clinical Trial

Official title:

A Randomized, Parallel-Cohort Phase 1 Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute Graft Versus Host Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614612
• Other study ID #: INCB 39110-108
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: August 2018

Study information

• Verified date: March 2019
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-host Disease (GVHD)

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess safety and tolerability of study treatment as measured by the frequency and severity of adverse events and serious adverse events		First dose of study drug to 30 days after the last dose of study drug
Secondary	Overall Response Rate (ORR)		Days 14, 28, 56 and 100
Secondary	Maximum Observed Plasma Concentration (Cmax) of the two treatment groups Itacitinib		Day 1 and Day 7
Secondary	Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups Itacitinib		Day 1 and Day 7
Secondary	Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups Itacitinib		Day 1 and Day 7
Secondary	Minimum observed plasma concentration (Cmin) of the two treatment groups Itacitinib		Day 1 and Day 7