A Study of Enzastaurin in Patients With Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-09-30

Brief Summary

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The primary objective of this study is to see if enzastaurin affects the pGSK3 beta level in B-cell chronic lymphocytic leukemia (B-CLL) cells.

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Detailed Description

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Conditions

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Leukemia, Lymphocytic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

enzastaurin

Intervention Type DRUG

1125 mg loading dose then 500 mg, oral, daily, up to 3 years or until progressive disease

Interventions

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enzastaurin

1125 mg loading dose then 500 mg, oral, daily, up to 3 years or until progressive disease

Intervention Type DRUG

Other Intervention Names

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LY317615

Eligibility Criteria

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Inclusion Criteria

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

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

1. Are unable to swallow tablets.
2. Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
3. Are pregnant or breastfeeding.
4. 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).
5. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No