PHASE II STUDY OF HIGH DOSE CYTARABINE COMBINED WITH A SINGLE HIGH DOSE OF IDARUBICIN FOR NEWLY DIAGNOSED PATIENTS WITH AML: THE AML-3 PROTOCOL


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Neutropenia

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Trial Information

PHASE II STUDY OF HIGH DOSE CYTARABINE COMBINED WITH A SINGLE HIGH DOSE OF IDARUBICIN FOR NEWLY DIAGNOSED PATIENTS WITH AML: THE AML-3 PROTOCOL


OBJECTIVES: I. Evaluate the effect of combined intensive induction and postremission therapy
with high-dose cytarabine plus a single high dose of idarubicin in patients with previously
untreated acute myelogenous leukemia (AML). II. Identify cytogenetic, molecular, or
immunophenotypic markers in AML patients for use in the study of residual disease.

OUTLINE: All patients receive high dose cytarabine for 5 days and idarubicin on the third
day as induction chemotherapy. Patients who achieve a complete remission (CR) proceed to
consolidation chemotherapy, as follows: cytarabine and etoposide for 5 days; and, for
patients aged 60 and under, cytarabine for 4 days, with idarubicin on the third day.
Patients eligible for the second consolidation course may have peripheral blood stem cells
collected following this regimen. Patients with an HLA-compatible donor then proceed to
allogeneic bone marrow transplantation, while patients over age 60, those with the t(8;21)
or inv16 cytogenetic abnormality, and those without an HLA-compatible donor receive
maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks,
then monthly for 5 months. G-CSF is administered with each chemotherapy regimen. Patients
are followed for survival.

PROJECTED ACCRUAL: 60 patients will be entered over 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: One of the following hematologic malignancies that is ineligible
for higher priority protocols and confirmed at Memorial Hospital: Acute myelogenous
leukemia Accelerated or blastic phase (greater than 10% blasts in marrow) chronic
myelogenous leukemia Poor-risk myelodysplastic syndrome, defined as: Refractory anemia
with excess blasts (RAEB) with at least 10% marrow blasts and cytopenia requiring therapy
RAEB in transformation Chronic myelomonocytic leukemia No acute promyelocytic leukemia

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Hematopoietic:
Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 3
times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater
than 60 mL/min Cardiovascular: No cardiomyopathy No symptomatic congestive heart failure
Other: No concurrent active malignancy No pregnant or nursing women

PRIOR CONCURRENT THERAPY: No prior therapy except biologic agent alone or hydroxyurea

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter Maslak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064897

NCT ID:

NCT00002800

Start Date:

July 1996

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Neutropenia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • untreated adult acute myeloid leukemia
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • de novo myelodysplastic syndromes
  • neutropenia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neutropenia

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021