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

Sponsor

BioCryst Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00289549

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphocytic, Chronic	Drug: forodesine hydrochloride (BCX-1777)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Outcome Measures

Primary Outcome Measures

Response rate after 2 cyclesof forodesine therapy. [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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