• Complete response rate [ Designated as safety issue: No ]
  
• Disease-free survival [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  
• Correlation of the density of CD52 molecules with response [ Designated as safety issue: No ]
  
• Correlation of the presence of minimal residual disease with overall outcome [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the complete response rate in patients with relapsed or refractory acute lymphoblastic leukemia treated with methotrexate, vincristine, asparaginase, and dexamethasone in combination with alemtuzumab.
• Determine disease-free and/or overall survival of patients treated with this regimen.
• Determine the toxic effects of this regimen in these patients.
• Correlate the density of CD52 molecules on the surface of leukemic lymphoblasts with response in patients treated with this regimen.
• Correlate the presence of minimal residual disease at the time of maximal response to this regimen with overall outcome in these patients.

OUTLINE: This is a multicenter study.

• Induction therapy: Patients receive methotrexate IV on day 1; vincristine IV and asparaginase intramuscularly (IM) on day 2; oral dexamethasone on days 1-10; and alemtuzumab subcutaneously on days 1, 4, and 7. Treatment repeats every 10 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) proceed to consolidation therapy.
• Consolidation therapy: Patients receive methotrexate IV on day 1 and asparaginase IM on day 2. Treatment repeats every 10 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who remain in CR proceed to cytoreduction therapy.
• Cytoreduction therapy: Patients receive vincristine IV and methotrexate IV over 6 hours on day 1; leucovorin calcium IV continuously over 24 hours on days 1 and 2 and then orally 4 times a day on day 3; and oral dexamethasone on days 2-6. Treatment repeats every 30 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients who remain in CR proceed to maintenance therapy.
• Maintenance therapy: Patients receive oral mercaptopurine on days 1-30; oral methotrexate on days 1, 8, 15, and 22; vincristine IV on day 1; and oral dexamethasone on days 1-5. Treatment repeats every 30 days for 36 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years from the date of registration to this study.

PROJECTED ACCRUAL: Approximately 85 patients will be accrued for this study.