Trial Information

A Phase II Study of MOAD (Methotrexate, Vincristine, L-asparaginase and Dexamethasone) With Subcutaneous Campath for Adults With Relapsed or Refractory Acute Leukemia (ALL)

OBJECTIVES:

I. Determine the complete response rate in patients with relapsed or refractory acute
lymphoblastic leukemia treated with methotrexate, vincristine, asparaginase, and
dexamethasone (MOAB) in combination with alemtuzumab.

II. Determine disease-free and/or overall survival of patients treated with this regimen.

III. Determine the toxic effects of this regimen in these patients. IV. Correlate the
density of CD52 molecules on the surface of leukemic lymphoblasts with response in patients
treated with this regimen.

V. 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.