Trial Information

Phase II Study Of Combined Modality Postremission Therapy As Determined By Molecular Response (Adaptive Regulation) In The Treatment Of Acute Promyelocytic Leukemia (APL)

OBJECTIVES:

- Determine the disease-free and overall survival of patients with acute promyelocytic
leukemia in clinical complete remission following tretinoin-based induction therapy
treated with monoclonal antibody HuG1-M195, arsenic trioxide, idarubicin, and
tretinoin.

- Determine the rate of molecular complete remission in patients treated with this
regimen.

- Determine the toxicity of this regimen in this patient population.

- Determine the number and length of hospitalizations of patients treated with this
regimen.

OUTLINE: Patients receive monoclonal antibody HuG1-M195 (MOAB HuM195) IV over 40-60 minutes
twice weekly for 3 weeks. Approximately 2-4 weeks after completion of MOAB HuM195, patients
receive arsenic trioxide IV over 1-4 hours daily for a total of 25 days with no more than 5
days between doses.

Beginning approximately 4-6 weeks after completion of arsenic trioxide, patients receive
idarubicin IV daily on days 1-3 or 1-4 and filgrastim (G-CSF) subcutaneously daily beginning
on day 5 or 6 and continuing until blood counts recover. Treatment repeats every 4 weeks for
patients who remain RT-PCR positive or are newly converted to RT-PCR negative (molecular
complete remission) following a prior course of idarubicin for a maximum of 3 courses.
Patients who remain RT-PCR positive following course 3 of idarubicin receive no further
treatment on study.

Beginning 3 months after completion of idarubicin, patients in molecular complete remission
receive oral tretinoin daily for 14 days. Treatment repeats every 3 months for a total of 6
courses in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 2-3
years.