RANDOMIZED PHASE III STUDY TO EVALUATE THE VALUE OF rHuG-CSF IN INDUCTION AND OF AN ORAL SCHEDULE AS CONSOLIDATION TREATMENT IN ELDERLY PATIENTS WITH ACUTE MYELOGENOUS LEUMEKIA (AML-13 PROTOCOL)
61 Years
80 Years
Both
Leukemia, Neutropenia
Trial Information
RANDOMIZED PHASE III STUDY TO EVALUATE THE VALUE OF rHuG-CSF IN INDUCTION AND OF AN ORAL SCHEDULE AS CONSOLIDATION TREATMENT IN ELDERLY PATIENTS WITH ACUTE MYELOGENOUS LEUMEKIA (AML-13 PROTOCOL)
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Acute myeloblastic leukemia (AML) At least 30% blast cells in
bone marrow smear Secondary AML eligible, as follows: Secondary to myelodysplastic
syndrome (but not other myeloproliferative diseases) Secondary to cured Hodgkin's disease
or other cured malignancy Secondary to alkylating agents or radiation for other reasons
Acute promyelocytic leukemia (M3) referred to the collaborative Gruppo Italiano Malattie
Ematologiche Maligne dell'Adulto-EORTC protocol (EORTC-06952) No blast crisis of chronic
myeloid leukemia
PATIENT CHARACTERISTICS: Age: 61 to 80 Performance status: WHO 0-2 Life expectancy: No
marked impairment from disease other than AML Hematopoietic: Not applicable Hepatic:
Bilirubin less than 2 x ULN Renal: Creatinine less than 2 x ULN Cardiovascular: LVEF at
least 50% No severe cardiac disease Pulmonary: No severe pulmonary disease Other: HIV
seronegative (if tested) No uncontrolled infection No severe neurologic, metabolic, or
psychiatric disease No other concomitant disease that precludes protocol therapy No other
progressive malignant disease
PRIOR CONCURRENT THERAPY: No prior chemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Roel Willemze, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Leiden University Medical Center
Authority:
United States: Federal Government
Study ID:
EORTC-06954
NCT ID:
NCT00002719
Start Date:
December 1995
Completion Date:
Related Keywords:
- Leukemia
- Neutropenia
- 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)
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Neutropenia
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