Humanized Monoclonal Anti-CD3 Antibody Visilizumab As Second-Line Therapy For Glucocorticoid-Refractory, Acute GVHD

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of grade II-IV acute graft-versus-host disease (GVHD) meeting 1 of the
following criteria:

- Progressive GVHD after receiving methylprednisolone (MePRDL) at a minimum dose
of 2 mg/kg for 3 days

- Persistent grade III or IV GVHD after receiving MePRDL and cyclosporine (CYSP)
or tacrolimus (FK506) for 7 days

- Persistent grade II GVHD after receiving MePRDL and CYSP or FK506 for 14 days

- Must meet at least 1 of the following criteria:

- Evaluable skin rash

- Evaluable diarrhea

- Abdominal pain and cramping

- Evaluable hyperbilirubinemia in the absence of clinically defined veno-occlusive
disease, viral hepatitis, or structural abnormalities, as indicated on either
liver ultrasound or CT scans

- Received prior allogeneic hematopoietic stem cell transplantation

- Patients continue GVHD prophylaxis with CYSP or FK506 at the dose tolerated by renal
function

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- Karnofsky 30-100% OR

- Lansky 30-100%

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- See Disease Characteristics

Renal:

- See Disease Characteristics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

Chemotherapy:

- Not specified

Endocrine therapy:

- See Disease Characteristics

Radiotherapy:

- Not specified

Surgery:

- Not specified