NCT02614612

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2015

Typical duration for phase_1

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

November 20, 2015

Last Update Submit

March 6, 2019

Conditions

Graft-versus-host Disease (GVHD)

Keywords

Acute Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Overall Response Rate (ORR)

    Days 14, 28, 56 and 100

  • Maximum Observed Plasma Concentration (Cmax) of the two treatment groups Itacitinib

    Day 1 and Day 7

  • Time to Reach the Maximum Plasma Concentration (Tmax) of the two treatment groups Itacitinib

    Day 1 and Day 7

  • Area Under the Plasma Concentration-time Curve (AUC) of the two treatment groups Itacitinib

    Day 1 and Day 7

  • Minimum observed plasma concentration (Cmin) of the two treatment groups Itacitinib

    Day 1 and Day 7

Study Arms (2)

Itacitinib (200 mg)

EXPERIMENTAL

Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids)

Drug: Itacitinib (200 mg)Drug: prednisone or methylprednisolone (corticosteroids)

Itacitinib (300 mg)

EXPERIMENTAL

Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids)

Drug: Itacitinib (300 mg)Drug: prednisone or methylprednisolone (corticosteroids)

Interventions

Itacitinib (200 mg)DRUG
Also known as: INCB039110
Itacitinib (200 mg)
Itacitinib (300 mg)DRUG
Also known as: INCB039110
Itacitinib (300 mg)
prednisone or methylprednisolone (corticosteroids)DRUG

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 (200 mg)Itacitinib (300 mg)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Unknown Facility

Duarte, California, United States

Location

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Coral Gables, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Kansas City, Kansas, United States

Location

Unknown Facility

Westwood, Kansas, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Hershey, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Related Publications (2)

  • 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.

    PMID: 35689489DERIVED

  • 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.

    PMID: 32324888DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

itacitinibINCB039110PrednisoneMethylprednisoloneAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPrednisolonePregnadienetriolsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Rodica Morariu-Zamfir, MD

    Incyte Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 25, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Study Completion

August 1, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

US(23)