Clofarabine and Low-Dose Total-Body Irradiation in Treating Patients With Acute Myeloid Leukemia Undergoing Donor Peripheral Blood Stem Cell Transplant

AML French-American-British (FAB) M3 in first complete remission (CR1)

Active AML involvement of the central nervous system (CNS) with disease refractory to intrathecal chemotherapy

Presence of circulating leukemic blasts in the peripheral blood detected by standard morphology

Patients who are human immunodeficiency virus (HIV)+ (HIV+ patients registered at Fred Hutchinson Cancer Research Center \[FHCRC\] should be offered treatment on Protocol 1410)

Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment

Left ventricular ejection fraction \< 35% (or, if unable to obtain ejection fraction, shortening fraction of \< 26%); ejection fraction is required if age \> 50 years or there is a history of anthracycline exposure or history of cardiac disease; patients with a shortening fraction \< 26% may be enrolled if approved by a cardiologist

Diffusion capacity of the lung for carbon monoxide (DLCO) \< 40% (corrected), total lung capacity (TLC) \< 40%, forced expiratory volume in one second (FEV1) \< 40% and/or receiving supplementary continuous oxygen

The FHCRC principal investigator (PI) of the study must approve enrollment of all patients with pulmonary nodules

Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bridging fibrosis, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3 mg/dL, or symptomatic biliary disease

Serum creatinine should be within normal limits as specified by institutional guidelines; for patients with serum creatinine \> upper limit of normal, a 24-hour creatinine clearance will be performed and should be equal to or more than the lower limit of normal

Karnofsky score \< 60 or Lansky score \< 50

Patients with poorly controlled hypertension and on multiple antihypertensives

Females who are pregnant or breastfeeding

Patients with active non-hematologic malignancies (except non-melanoma skin cancers) or those with non-hematologic malignancies (except non-melanoma skin cancers) who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within five years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy

The addition of cytotoxic agents for "cytoreduction" with the exception of tyrosine kinase inhibitors (such as imatinib mesylate), cytokine therapy, hydroxyurea, low dose cytarabine, chlorambucil, or Rituxan will not be allowed within three weeks of the initiation of conditioning

Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month

Patients with active bacterial or fungal infections unresponsive to medical therapy

DONOR: Marrow donors

DONOR: Donors who are HIV-positive and/or medical conditions that would result in increased risk to the donor filgrastim (G-CSF) mobilization and PBSC collections

DONOR: Identical twin

DONOR: Any contraindication to the administration of subcutaneous G-CSF at a dose of 16 mg/kg/day for 5 consecutive days

DONOR: Serious medical or psychological illness

DONOR: Pregnant or lactating females

DONOR: Prior malignancy within the preceding 5 years, with the exception of non-melanoma skin cancers

DONOR: Children \< 12 years old

What this study is about