A Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B)

Phase 3

Completed

• Conditions: Leukemia

• Registration Number: NCT01324063
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

Detailed Description

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.

Study Timeline

• Primary Completion: 1994-06
• Study First Submitted: 2011-03-25
• Study First Submitted QC: 2011-03-25
• Study First Posted: 2011-03-28
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-13
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life
Toxicity
Disease-free survival and overall survival in patients who achieve complete remission after induction
Improved therapeutic results as measured by activation of leukemic cells into the cell cycle and/or acceleration of hematopoietic recovery
Relative efficacy of autologous bone marrow therapy