Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
Condition: Leukemia; Neutropenia
MeSH terms: Leukemia; Neutropenia
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number
      of immune cells found in the bone marrow or peripheral blood and may help a person's immune
      system recover after chemotherapy and radiation therapy. Combining more than one drug and
      giving drugs in different ways may kill more cancer cells.

      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
      with or without G-CSF in treating older patients with acute myeloid leukemia.
    

Detailed description: 
      OBJECTIVES: I. Assess the role of granulocyte colony-stimulating factor given during and/or
      after remission induction with MICE (mitoxantrone/cytarabine/etoposide) in elderly patients
      with acute myelogenous leukemia (AML). II. Compare the complete remission (CR) rate and
      survival of these patients when treated with nearly equivalent doses of oral vs. intravenous
      mini-ICE (idarubicin/cytarabine/etoposide) as consolidation therapy given on an outpatient
      basis. III. Evaluate the feasibility of a second intensive consolidation regimen consisting
      of BAVC (carmustine/amsacrine/etoposide/cytarabine) followed by autologous stem cell support
      in patients under age 71 who are in CR and have good performance status.

      OUTLINE: Randomized study. All patients are randomly assigned to Arms IA through ID for
      Induction. Patients who achieve CR and who have adequate organ function and performance
      status are then randomly assigned to Arm IIA or IIB for Consolidation. At selected centers,
      patients in CR after their first Consolidation course who are under age 71 and in very good
      clinical condition are treated on Regimen A (in lieu of a second Consolidation course). The
      following acronyms are used: AMSA Amsacrine, NSC-249992 ARA-C Cytarabine, NSC-63878 BAVC
      BCNU/AMSA/VP-16/ARA-C BCNU Carmustine, NSC-409962 DHAD Mitoxantrone, NSC-301739 G-CSF
      Granulocyte Colony-Stimulating Factor (Rhone-Poulenc Rorer) IDA Idarubicin, NSC-256439 MICE
      DHAD/ARA-C/VP-16 Mini-ICE IDA/ARA-C/VP-16 PBSC Peripheral Blood Stem Cells VP-16 Etoposide,
      NSC-141540 INDUCTION: Arm IA: 3-Drug Combination Chemotherapy. MICE. Arm IB: 3-Drug
      Combination Chemotherapy plus Hematologic Toxicity Attenuation. MICE; plus G-CSF. G-CSF
      during chemotherapy. Arm IC: 3-Drug Combination Chemotherapy plus Hematologic Toxicity
      Attenuation. MICE; plus G-CSF. G-CSF after chemotherapy. Arm ID: 3-Drug Combination
      Chemotherapy plus Hematologic Toxicity Attenuation. MICE; plus G-CSF. G-CSF during and after
      chemotherapy. CONSOLIDATION: Arm IIA: 3-Drug Combination Chemotherapy. Mini-ICE. Intravenous
      IDA/VP-16/ARA-C. Arm IIB: 3-Drug Combination Chemotherapy. Mini-ICE. Oral IDA/VP-16 +
      subcutaneous ARA-C. Regimen A: Stem Cell Mobilization followed by 4-Drug Combination
      Myeloablative Chemotherapy with Stem Cell Rescue. G-CSF; followed by BAVC; with PBSC.

      PROJECTED ACCRUAL: 500 patients will be randomized for Induction, of whom an anticipated 238
      patients will be randomized for Consolidation. If at interim analyses survival is shorter on
      Regimen A, that regimen will be closed.
    

Intervention name(s): filgrastim; amsacrine; carmustine; cytarabine; etoposide; idarubicin; mitoxantrone hydrochloride; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cytarabine; Etoposide; Mitoxantrone; Idarubicin; Carmustine; Amsacrine
Allocation: Randomized
Primary purpose: Treatment
Keywords: untreated adult acute myeloid leukemia; adult acute erythroid leukemia (M6); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute megakaryoblastic leukemia (M7); secondary acute myeloid leukemia; adult acute monocytic leukemia (M5b); neutropenia; adult acute minimally differentiated myeloid leukemia (M0)