A Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B)
OBJECTIVES: I. Assess the value (in terms of disease-free survival and overall survival) of
short intensive consolidation with high-dose cytosine arabinoside in patients with acute
myelogenous leukemia who achieve complete remission after induction with daunorubicin and
cytosine arabinoside. II. Assess the toxicity and resulting quality of life associated with
consolidation with high-dose cytosine arabinoside compared with conventional
consolidation/maintenance treatment. III. Determine whether addition of
granulocyte-macrophage colony stimulating factor (GM-CSF) to Induction chemotherapy can
improve therapeutic results through activation of leukemic cells into the cell cycle and/or
acceleration of hematopoietic recovery (objective added 08/90). IV. Determine indirectly
whether autologous bone marrow therapy is better than conventional consolidation/maintenance
or high-dose cytosine arabinoside by comparing results from protocol EORTC-06863 (AML 8 A).
OUTLINE: Patients with normal kidney function are randomized on Arms A-D for Induction
(patients whose serum creatinine is more than 1.5 x the upper limit of normal are
nonrandomly assigned to Arm A). Following Induction, patients achieving CR are randomized to
Arms I and II. Induction: Arm A: 2-Drug Combination Chemotherapy. Daunorubicin, Daunomycin,
DNM, DNR, NSC-82151; Cytosine arabinoside, ARA-C, NSC-63878. Arm B: 2-Drug Combination
Chemotherapy plus Growth Factor Therapy. DNM; ARA-C; plus Granulocyte-Macrophage Colony
Stimulating Factor (Sandoz), GM-CSF. GM-CSF on days 0 through 7. Arm C: 2-Drug Combination
Chemotherapy with Hematologic Toxicity Attenuation. DNM; ARA-C; GM-CSF. GM-CSF from end of
chemotherapy through day 28. Arm D: 2-Drug Combination Chemotherapy plus Growth Factor
Therapy and Hematologic Toxicity Attenuation. DNM; ARA-C; GM-CSF. GM-CSF on days 0 through
28. Arm I: Intensive Consolidation: 2-Drug Combination Chemotherapy followed by 2-Drug
Combination Chemotherapy. High-dose ARA-C, HDARA-C; Acridinylanisidide, m-AMSA, AMSA,
NSC-249992; followed by HDARA-C; DNR. Arm II: Standard Consolidation/Maintenance: 2-Drug
Combination Chemotherapy. ARA-C; DNR.
PROJECTED ACCRUAL: A minimum of 157 patients will be required; with an expected entry rate
of 40 patients per year, patient entry is expected to take 4 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Disease-free survival and overall survival in patients who achieve complete remission after induction
No
Robert A. Zittoun, MD
Study Chair
Hotel Dieu de Paris
United States: Federal Government
EORTC-06864
NCT01324063
November 1986
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