Trial Information

Treatment of Newly Diagnosed Childhood AML Using a Timed-Sequential Remission Induction and Consolidation Followed by Single Dose Melphalan With Peripheral Stem Cell Rescue: A POG Pilot Study

OBJECTIVES: I. Determine the feasibility and toxicity of timed sequential remission
induction and consolidation in children with newly diagnosed acute myeloid leukemia. II.
Determine the feasibility and toxicity of a single high dose of melphalan with peripheral
blood stem cell rescue following an intense timed sequential induction and consolidation in
these children.

OUTLINE: This is a multicenter study. Remission induction: Patients receive daunorubicin IV
over 15 minutes on days 1-3, cytarabine IV continuously on days 1-7, oral thioguanine daily
on days 1-7, and cytarabine intrathecally (IT) on day 1. Cytarabine IV over 3 hours is
administered every 12 hours on days 10-12. Filgrastim (G-CSF) is administered IV or
subcutaneously (SQ) beginning on day 13 and continuing until blood counts recover. On
approximately day 28, patients undergo a bone marrow aspirate and biopsy to assess response.
Patients who have attained an M1 or M2a status proceed to consolidation or, if a 5/5 or 6/6
HLA matched sibling donor is available, proceed to allogeneic bone marrow transplantation.
Patients with greater than 25% blasts go off study. Consolidation 1: Patients receive
daunorubicin IV over 15 minutes on days 1 and 2, cytarabine IV over 3 hours every 12 hours
on days 1, 2, 8, and 9, and asparaginase on days 2 and 9. G-CSF IV or SQ begins on day 10
and continues until blood counts recover. Consolidation 2: Patients receive cytarabine IV
over 3 hours every 12 hours on days 1, 3, and 5. G-CSF IV or SQ begins on day 6 and
continues until blood counts recover. Peripheral blood stem cells (PBSC) are collected after
the second course of consolidation. Consolidation 3: Treatment is repeated as in
consolidation 1. Patients who remain in morphologic remission after consolidation 3 proceed
with therapy. Patients receive melphalan IV over 30 minutes on day -2, then PBSC are
reinfused on day 0. G-CSF IV or SQ begins on day 1 and continues until blood counts recover.
Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 8 months.