Protocol for Patients With High Risk (Resistant, Refractory, Relapsed or Adverse Cytogenetic) AML
Protocol for Patients With High Risk (Resistant, Refractory, Relapsed or Adverse Cytogenetic) AML
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 filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether combination chemotherapy with filgrastim and/or tretinoin is more effective than combination chemotherapy alone for acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying combination chemotherapy with filgrastim and/or tretinoin to see how well they work compared to combination chemotherapy alone in treating patients with acute myeloid leukemia.
OBJECTIVES:
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to type of disease (resistant vs refractory vs relapsed vs adverse cytogenetic), age (under 15 vs 15 to 29, vs 30 to 49 vs 50-59 vs 60-69 vs 70 and over), performance status, and de novo and secondary leukemia. Patients with relapsed disease are further stratified according to duration of first remission (less than 6 months vs 6 to 12 months vs 12 months and over), and prior transplantation (yes vs no).
Patients are randomized into one of two treatment arms for induction chemotherapy.
Patients are further randomized into one of two treatment arms for colony stimulating factor therapy.
Following completion of induction chemotherapy, patients achieving complete remission and blood count recovery may receive subsequent therapy consisting of consolidation chemotherapy and/or autologous or allogeneic transplantation.
Quality of life is assessed at 3 months.
PROJECTED ACCRUAL: Approximately 800-1,000 patients will be accrued for this study within 4-5 years.
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) including de novo or secondary AML, or a preexisting myelodysplastic syndrome
Overt resistant disease with more than 15% bone marrow blasts after induction course
Primary refractory disease
Relapse from first remission with more than 5% bone marrow blasts
Complete or partial remission following 1 induction course with adverse cytogenetic abnormalities at diagnosis
No acute promyelocytic leukemia
No chronic myeloid leukemia in blast transformation
No prior relapse from a second or greater remission
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery