Table 1.

Entry Criteria

Inclusion

Informed consent

Age > 18 years

ECOG performance status of 0 or 1

Adequate hematology

Neutrophil count ≥ 1.0 × 109/L

Platelet count ≥ 75 × 109/L

Hemoglobin concentration ≥ 90 g/L

Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥ 50 mL/min

Adequate liver function

AST, ALT ≤ 3 × ULN

Bilirubin ≤ 1.5 × ULN

Normal coagulation profile

Exclusion

History of immune thrombocytopenia or refractoriness to platelet transfusion in the last 12 months

Ongoing use of an antiplatelet agent or anticoagulant therapy

Current bleeding or history of active peptic ulcer disease or erosive gastritis/esophagitis

History of significant cardiovascular disease (eg, myocardial infarction, thrombotic event, or thromboembolic event in the last 6 months)

Active infection

Current pregnancy or breastfeeding

Previous stem-cell transplantation

NOTE. All patients had an original diagnosis of chronic lymphocytic leukemia, but lymphocytosis was not required at study entry.

Abbreviation: ECOG, Eastern Cooperative Oncology Group; ULN, upper limit of normal.