RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.

OBJECTIVES:

Primary

• Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease (GVHD) treated with alemtuzumab, tacrolimus, and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation.

Secondary

• Determine the best response at 4 and 12 weeks in patients treated with this regimen.
• Determine 6-month survival of patients treated with this regimen.
• Determine the rate of infectious complications in patients treated with this regimen.
• Determine rate of chronic GVHD in patients treated with this regimen.

OUTLINE: This is an open-label, single-blind, multicenter study.

Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14; tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease; and alemtuzumab IV over 2 hours on days 4-6, 18, and 32. Treatment continues in the absence of unacceptable toxicity or the development of serious infection.

After completion of study treatment, patients are followed at 2 and 4 weeks.

PROJECTED ACCRUAL: A total of 9-34 patients will be accrued for this study within 8-12 months.

DISEASE CHARACTERISTICS:

• Diagnosis of acute graft-vs-host disease (GVHD)

  • Clinical grade C or D disease

    • No grade C disease with single organ skin involvement

• Has undergone allogeneic stem cell transplantation within the past 100 days

  • Absolute neutrophil count > 500/mm^3 (donor-derived [> 60% by peripheral blood lymphocyte chimerism analyses])

• No development of GVHD after prior donor lymphocyte infusion

• Must have received prior prophylactic cyclosporine or tacrolimus at the onset of acute GVHD

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• No serologic evidence of active hepatitis B or C infection

Renal

• Creatinine ≤ 3.5 mg/dL
• No requirement for dialysis

Cardiovascular

• No requirement for vasopressors

Pulmonary

• No requirement for a ventilator

Other

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• No known HIV positivity
• No active uncontrolled infection
• No other organ dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified