PHASE II MULTICENTER STUDY OF NATALIZUMAB PLUS STANDARD STEROID TREATMENT FOR HIGH RISK ACUTE GRAFT-VERSUS-HOST DISEASE

Protocol: 
AAAQ8173
Phase: 
II

PHASE II MULTICENTER STUDY OF NATALIZUMAB PLUS STANDARD STEROID TREATMENT FOR HIGH RISK ACUTE GRAFT-VERSUS-HOST DISEASE

1. To improve day 28 GVHD complete response rate for high risk GVHD patients from the historical rate of 30% to 45% by treatment with natalizumab and high dose systemic corticosteroids (2 mg/kg). 2. To decrease 6-month NRM from the historical rate of 45% to 35% in patients treated on this clinical trial.

Are you Eligible? (Inclusion Criteria)

1. New onset acute GVHD Ann Arbor score 3 following allogeneic BMT. Any
clinical severity (Glucksberg grade I-IV) is eligible.

2. Any donor type (e.g., related, unrelated) or stem cell source (bone
marrow, peripheral blood, cord blood). Recipients of non-myeloablative and
myeloablative transplants are eligible.

3. No prior systemic treatment for acute GVHD except for a maximum of 3 days
of prednisone ≤2 mg/kg/day (or IV methylprednisolone equivalent). Topical
skin steroid treatment and non-absorbable oral steroid treatment for GI GVHD
are permissible.

4. Age 18 years or older.

5. Direct bilirubin must be <2 mg/dL unless the elevation is known to be due
to Gilbert syndrome or aGVHD within 3 days of enrollment