Alemtuzumab and Glucocorticoids in Treating Newly Diagnosed Acute Graft-Versus-Host Disease in Patients Who Have Undergone a Donor Stem Cell Transplant

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Alemtuzumab and glucocorticoids, such as prednisone or methylprednisolone, may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell transplant.

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alemtuzumab; Glucocorticoids; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed acute graft-versus-host disease (GVHD)

• Grade IIB-IV disease

• Requires glucocorticoids for treatment of GVHD, as indicated by 1 of the following:

• Initial treatment with prednisone or methylprednisolone at 2 mg/kg is indicated (in the judgement of the attending physician) by any of the following:

• Severity of GVHD requires hospitalization

• GVHD manifestations include symptoms other than anorexia, nausea, and vomiting

• GVHD begins within 2-3 weeks after hematopoietic stem cell transplantation (HSCT)

• GVHD manifestations progress rapidly from 1 day to the next before treatment

• Initial treatment with prednisone or methylprednisolone at 1 mg/kg did not produce adequate clinical improvement within the first 4 days (in the judgement of the attending physician)

• Has undergone allogeneic HSCT with myeloablative conditioning

• No nonmyeloablative conditioning or autologous HSCT

• No primary treatment of acute GVHD with methylprednisolone at any of the following doses:

• More than 2 mg/kg/day at any time

• 2 mg/kg/day for > 72 hours

• 1 mg/kg/day for > 96 hours

• No presence of distinctive or diagnostic manifestations of chronic GVHD

• No relapsed, refractory, or secondary malignancy

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 20-100% OR Lanksy PS 20-100%

• Life expectancy ≥ 1 month

• Absolute neutrophil count ≥ 500/mm^3

• Negative pregnancy test

• No Mini Mental State Exam score < 24/30 or confusion (for patients > 12 years of age)

• No history of type I hypersensitivity reaction to alemtuzumab or any of its components

• No increasing levels of viremia by serial quantitative viral plasma polymerase chain reaction assays

• No invasive viral or fungal disease that does not respond to appropriate antiviral or antifungal medications

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No systemic immunosuppression tapered or stopped for treatment of leukemic relapse or minimal residual disease