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Expanded Access Program for Axatilimab in Chronic Graft Versus Host Disease (GVHD)

Status
Active
Cancer Type
Graft Versus Host Disease
Trial Phase
Eligibility
6 Years and older (Child, Adult, Older Adult ), Male and Female
Study Type
NCT ID
NCT05544032
Protocol IDs
INCA 34176-MA-GD-301 (primary)
Study Sponsor
Incyte Corporation Medical Information Call Center (US)
NCI Full Details

Summary

To provide axatilimab 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 axatilimab in the treatment of GVHD.

Eligibility

Inclusion Criteria:

  • Must be 6 years of age or older.
  • Allogeneic HSCT recipients with active cGVHD.
  • Has refractory or recurrent active cGVHD despite at least 2 lines of systemic therapy.
  • Be willing to avoid pregnancy or fathering children.
  • Able to provide written informed consent and/or assent from the patient, parent, or guardian.

Exclusion Criteria:

  • Eligible to participate in any actively enrolling axatilimab clinical trial for the treatment of cGVHD.
  • History of acute or chronic pancreatitis.
  • Has active symptomatic myositis.
  • Has known HIV seropositive status.
  • Has active, uncontrolled systemic bacterial, fungal, parasitic, or viral infection.
  • Has active HBV or HCV.
  • Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


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