A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft Versus-Host Disease

  • STATUS
    Recruiting
  • sponsor
    Incyte Corporation
Updated on 8 December 2020
stem cell transplantation
bone marrow transplant
transplant conditioning
stem cell transplant
nutritional supplement

Summary

A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft Versus-Host Disease

Description

This is an open-label, single-cohort, multicenter Phase 2 study of ruxolitinib in combination with corticosteroids for the treatment of steroid-refractory Grades II to IV acute GVHD.

Study Start Date: November 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: March 2020

Details
Condition Bone marrow transplant, Stem Cell Transplant
Clinical Study IdentifierTX146567
SponsorIncyte Corporation
Last Modified on8 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible
Clinically suspected Grades IIB to IVD acute GVHD as per Minnesota-Center for International Blood and Marrow Transplant Research (MN-CIBMTR) criteria, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program
Subjects with steroid-refractory acute GVHD, defined as any of the following
Subjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after 3 days of primary treatment with methylprednisolone = 2 mg/kg per day (or equivalent)
Subjects with GVHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 7 days of primary treatment with methylprednisolone = 2 mg/kg per day (or equivalent)
Subjects who previously began corticosteroid therapy at a lower dose (at least 1 mg/kg per day methylprednisolone) but develop new GVHD in another organ system
Subjects who cannot tolerate a corticosteroid taper, that is, begin corticosteroids at 2.0 mg/kg per day, demonstrate response, but progress before a 50% decrease from the initial starting dose of corticosteroids is achieved
Evidence of myeloid engraftment (eg, absolute neutrophil count = 1.0 × 109/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed
Evidence of platelet engraftment (ie, platelets = 20 × 109/L)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3

Exclusion Criteria

Has received more than 1 allo-HSCT
Has received more than 1 systemic treatment in addition to corticosteroids for acute GVHD
Presence of GVHD overlap syndrome as per NIH guidelines
Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection
Known human immunodeficiency virus infection
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