Clofarabine and Gemtuzumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:

  • Refractory disease, defined as persistent or progressive disease after ≥ 2 induction regimens, including ≥ 1 course of high-dose cytarabine (ARA-C)
  • Relapsed disease that has recurred within 1 year of an ARA-C-containing chemotherapy regimen

• No CNS disease requiring radiotherapy

  • Patients with neurological symptoms must undergo a lumbar puncture and a CT scan or MRI of the brain to exclude brain metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
• ALT and AST ≤ 2.0 times the ULN
• Serum creatinine ≤ 1.0 mg/dL OR glomerular filtration rate > 60 mL/min

• INR ≤ 1.5 and aPTT within ULN

  • Patients receiving anticoagulation therapy (e.g., warfarin or heparin) are eligible provided anticoagulation therapy can be discontinued or changed to parenteral medications while the platelet count is less than 50,000/mm³
• Negative pregnancy test
• Fertile patients must use effective contraception
• No concurrent active second primary malignancy (excluding superficial, non-invasive skin cancers)
• No active bleeding diathesis, not including closely monitored therapeutic anticoagulation

• No cardiac disease, including any of the following:

  • New York Heart Association class II-IV congestive heart failure
  • Unstable angina (i.e., anginal symptoms at rest)
  • New onset angina (i.e., began within the past 3 months)
  • Myocardial infarction within the past 6 months
• No active clinically serious infection > grade 2
• No cerebrovascular accident, including transient ischemic attacks, within the past 6 months
• No pulmonary hemorrhage ≥ grade 2 within the past 4 weeks
• No other hemorrhage or bleeding event ≥ grade 3 within the past 4 weeks
• No known HIV infection or chronic hepatitis B or C
• No serious non-healing wound or ulcer
• More than 4 weeks since prior significant traumatic injury
• No prior history of sinusoidal obstructive syndrome (veno-occlusive disease)

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior major surgery or open biopsy
• More than 100 days since any prior hematopoietic stem cell transplant

• No concurrent treatment with any other investigational agent for AML

  • Intrathecal chemotherapy administration is allow for central nervous system leukemic infiltration
• No prior allogeneic stem cell transplant within the past 100 days, with active graft-versus-host disease (GVHD) of any grade, or exposure to immynosuppression for GVHD or prophylaxis