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Completed

NCT Number: NCT02614612

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

To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).

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Key information

Conditions

Graft-versus-host Disease (GVHD) Graft vs Host Disease Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Itacitinib (200 mg)

Drug

Other names: INCB039110

Itacitinib (300 mg)

Drug

Other names: INCB039110

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.

Primary outcomes

  1. 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 outcomes

  1. Overall Response Rate (ORR)

    Time frame: Days 14, 28, 56 and 100

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

    Time frame: Day 1 and Day 7

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

    Time frame: Day 1 and Day 7

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

    Time frame: Day 1 and Day 7

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

    Time frame: Day 1 and Day 7

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Nov 25, 2015
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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