A Study of Enzastaurin in Patients With Leukemia

Inclusion criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:

• Patients with B-cell CLL as diagnosed by expression of CD19, CD5, and CD23 by flow cytometry.
• Rai Stage III or IV disease or earlier stage disease with indications for therapy per NCI Working Group criteria (Cheson et al. 1996)
• Absolute lymphocyte count > or = to 5,000/microliter, with a lymphocyte WBC differential of > or = to 70%.
• Platelet count >20,000/microliter.
• Adequate organ function, including the following:

• Hepatic: bilirubin < or = to 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) < or = to 2.5 x ULN
• Renal: serum creatinine < or = to 1.5 X ULN.

Exclusion criteria

Patients will be excluded from the study if they meet any of the following criteria:

• Are unable to swallow tablets.
• Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
• Are pregnant or breastfeeding.
• Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy).
• Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.