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

Incyte

Status

Conditions: Chronic Graft Vs. Host Disease

Treatments: Drug: axatilimab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05544032

INCA 34176-MA-GD-301

Details and patient eligibility

About

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.

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.