Patient case: 13-year-old male with acute myeloid leukemia; genetic feature: FLT3

Clinical trial: flt3L in Treating Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Drugs such as flt3L may stimulate a person's immune system and help kill cancer cells. It is not yet known if flt3L is effective in treating acute myeloid leukemia.
  PURPOSE: Randomized phase III trial to determine the effectiveness of flt3L in treating patients who have acute myeloid leukemia that is in remission.

Detailed description: OBJECTIVES:
  -  Compare the failure-free survival and overall survival in patients with acute myeloid leukemia in complete remission treated with maintenance flt3 ligand vs observation alone.
  -  Compare the long-term immunologic effects of these regimens in these patients.
  -  Compare the long-term safety and toxicity of these regimens in these patients.
  OUTLINE: This is a randomized study. Patients are stratified according to complete remission (CR) (first vs second vs third or subsequent) and post-remission therapy (yes vs no). Patients are randomized to one of two treatment arms.
  -  Arm I: Patients receive flt3 ligand subcutaneously daily on days 1-14. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
  -  Arm II: Patients undergo observation alone. Patients begin treatment or observation within 4 weeks after documentation of CR after induction therapy or within 4 weeks after discharge from hospital after post-remission therapy.
  Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 139 patients will be accrued for this study within approximately 28 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia in first, second, third, or subsequent complete remission (CR)
  -  Must be at least 60 years of age if first CR
  -  Must have had histological proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of one of the following prior to achieving CR:
  -  Acute myeloblastic leukemia (M0, M1, M2)
  -  Acute promyelocytic leukemia (M3)
  -  Acute myelomonocytic leukemia (M4)
  -  Acute monocytic leukemia (M5)
  -  Acute erythroleukemia (M6)
  -  Acute megakaryocytic leukemia (M7)
  -  Refractory anemia with excess blasts in transformation
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin less than 3 times upper limit of normal (ULN)
  -  SGOT less than 3 times ULN
  Renal:
  -  Creatinine less than 2 mg/dL
  Cardiovascular:
  -  No clinically significant active cardiac disease
  Pulmonary:
  -  No clinically significant active pulmonary disease
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No uncontrolled or active autoimmune disease
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Prior autologous bone marrow transplantation (BMT) allowed
  -  No prior allogeneic BMT
  -  Other prior immunotherapy allowed if not received during the most recent treatment
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Not specified

Relevance to patient case: not relevant