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


Phase 3
45 Years
60 Years
Not Enrolling
Both
Leukemia

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Newly diagnosed, untreated acute myelogenous leukemia (AML), as
follows: Any cytological type according to the FAB classification At least 30% blast cells
in bone marrow smear required Secondary acute leukemia eligible, i.e.: AML cured Hodgkin's
disease or other malignancy AML following exposure to alkylating agents or radiation The
following are specifically excluded: Blast crisis of chronic myeloid leukemia Leukemia
supervening after other myeloproliferative disease Leukemia supervening after overt
myelodysplastic disorder (e.g., refractory anemia with excess blasts) of more than 6
months' duration

PATIENT CHARACTERISTICS: Age: 45-60 Patients 10-45 are eligible for EORTC-06863
Performance status: Not specified Hematopoietic: Not specified Hepatic: No severe
concomitant hepatic disease Renal: No severe concomitant renal disease Cardiovascular: No
severe concomitant cardiac disease Other: No severe concomitant neurological disease No
other progressive malignant disease

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior
chemotherapy Endocrine therapy: No more than 7 days of corticosteroids for AML
Radiotherapy: No prior radiotherapy Surgery: Not applicable

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival and overall survival in patients who achieve complete remission after induction

Safety Issue:

No

Principal Investigator

Robert A. Zittoun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hotel Dieu de Paris

Authority:

United States: Federal Government

Study ID:

EORTC-06864

NCT ID:

NCT01324063

Start Date:

November 1986

Completion Date:

Related Keywords:

  • Leukemia
  • untreated adult acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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