Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)

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

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2009-01-31

Brief Summary

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Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days).

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Detailed Description

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Conditions

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Leukemia, Lymphocytic, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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forodesine hydrochloride (BCX-1777)

experimental, forodesine oral dose 200 mg administered daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages 18 years and older
* Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria
* Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
* Primary resistance to fludarabine-based therapy (no complete response \[CR\] or partial response \[PR\]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
* ECOG performance status of 0, 1, 2 or 3
* Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after
* All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug.

Exclusion Criteria

* Pregnant or nursing
* Unable or unwilling to sign consent
* Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy
* Active serious infections that are not controlled by antibiotics
* ECOG performance status 4
* Inadequate renal function: creatinine 2.0 or more unless related to the disease
* Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease
* Known positive test for HIV
* Patients with known hepatitis B and/or hepatitis C active infection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No