Expanded Access Program for Axatilimab in Chronic Graft Versus Host Disease (GVHD)
- Conditions
- Chronic Graft Vs. Host Disease
- Registration Number
- NCT05544032
- Lead Sponsor
- Incyte Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
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.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method