Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease

Inclusion Criteria

• •1. Histologic documentation of chronic GvHD following allogeneic HCT or donor lymphocyte infusion.
• •2. Patients may have progressive, quiescent, or de novo onset chronic GvHD.
• •3. Patients with extensive stage chronic GvHD requiring systemic immunosuppressive therapy are eligible. Patients with limited stage disease are excluded. Extensive stage is defined according to Seattle criteria (9) as either:
• •* Generalized skin involvement or
• •* Limited skin involvement or hepatic involvement with any one of the following:
• •* Liver histology showing chronic progressive hepatitis, bridging necrosis or cirrhosis
• •* Eye involvement (Schirmer's test with \< 5 mm wetting)
• •* Involvement of minor salivary glands or oral mucosa
• •* Involvement of any other organ
• •4. Patients must have failed treatment with, or experience progression after, prior corticosteroids for extensive stage chronic GvHD, as defined below.
• •4.1 Patients will be considered to have failed corticosteroids if they have any one of the following criteria:
• •* Progressive disease or less than a minor response in any organ system despite 2 weeks on corticosteroid treatment at least 1 mg/kg methylprednisolone or equivalent.
• •* Failure to achieve at least a minor response after at least 4 weeks of treatment with a dose of ≥ 0.5 mg/kg methylprednisolone or equivalent.
• •* Achievement of less than a partial response at 8 weeks of corticosteroid treatment despite use of a dose ≥ 0.5 mg/kg methylprednisolone or equivalent.
• •* Requirement of ≥ 0.5 mg/kg methylprednisolone or equivalent to maintain a partial response or better at 12 weeks of corticosteroid treatment.
• •* Requirement of \> 10 mg/kg methylprednisolone or equivalent to maintain a partial response or better at 18 weeks of corticosteroid treatment.
• •4.2 Patients with progression of extensive stage chronic GvHD after a prior history of treatment with at least 18 weeks of corticosteroids, now requiring the reintroduction of corticosteroids (\> 10 mg/day methylprednisolone or equivalent) or an additional agent (including photopheresis, PUVA) for treatment.
• •6. Age ≥ 18 years
• •7. Performance Status 0-3
• •8. Patients on mechanical ventilation are excluded.