GVHD

An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

Incyte Study ID:
INCB 18424-MA-GD-301
CT.gov ID:
NCT03147742
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

To provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.

Clinical Study Summary

MEDICAL CONDITION(S)
  • GVHD
    • PRODUCT
  • Drug: Ruxolitinib
    • COLLABORATORS
    N/A
    DATE
    N/A - N/A
    TYPE
    Expanded Access
    PHASE
    N/A
    SEX
    Female & Male
    AGE
    12+ years
    ACCEPTS HEALTHY VOLUNTEERS

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male or female, 12 years of age or older.
    • Have undergone an 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.

    Exclusion Criteria

    • Eligible for an existing and actively enrolling Incyte sponsored clinical trial for ruxolitinib for the treatment of GVHD.
    • Clinically suspected all grades of acute GVHD as per Minnesota-Center for International Blood and Marrow Transplant Research (MN-CIBMTR) criteria or clinical suspicion of acute GVHD by the treating physician.

    Clinical Study Locations

    Location
    Status
    Location
    Avera Research Institute
    Sioux Falls, South Dakota, US, 57105
    Status
    Completed
    Location
    Memorial Sloan Kettering Cancer Center
    New York, New York, US, 10065
    Status
    Completed
    Location
    Greenville Health System Cancer Institute
    Greenville, South Carolina, US, 29615
    Status
    Completed
    Location
    Cancer Center of Kansas
    Wichita, Kansas, US, 67214
    Status
    Completed
    Location
    Hackensack University Medical Center
    Hackensack, New Jersey, US, 07601
    Status
    Completed
    Location
    Oregon Health & Science University
    Portland, Oregon, US, 97239
    Status
    Completed

    Protocol Summary

    Incyte Study ID:
    INCB 18424-MA-GD-301
    Primary Purpose:
    N/A
    Allocation:
    N/A
    Study Design:
    N/A
    Masking:
    N/A
    Interventions:
    Drug
    Enrollment:
    Primary Outcome
    Open
    Secondary Outcome
    Open