Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give
higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by
melphalan and peripheral stem cell transplantation in treating children who have newly
diagnosed acute myeloid leukemia that has not been treated previously.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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