Conditions: Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Recurrent Adult Acute Myeloid Leukemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with cytarabine may kill more cancer cells.

PURPOSE: This pilot phase II trial is studying how well giving clofarabine together with cytarabine works in treating patients with acute myeloid leukemia with minimal residual disease

Detailed description:
PRIMARY OBJECTIVES:

I. To test the ability of clofarabine + ara-C (cytarabine) to eliminate minimal residual (MRD) in acute myeloid leukemia (AML) patients whose bone marrows exhibit complete remission by morphology.

SECONDARY OBJECTIVES:

I. To determine the duration of complete remission after this treatment to minimize MRD.

OUTLINE:

Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily (QD) on days 1-5 and clofarabine intravenously (IV) over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, and then annually for 3 years.

Arms:
arm 1: Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: clofarabine intervention 2: cytarabine intervention 3: filgrastim
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given SC

Protocol document: