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

Leukemia, Lymphocytic, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289549
• Other study ID #: BCX1777-Bo-05-204
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2006
• Last updated: February 6, 2012
• Start date: June 2005
• Est. completion date: January 2009

Study information

• Verified date: February 2012
• Source: BioCryst Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• forodesine hydrochloride (BCX-1777)
experimental, forodesine oral dose 200 mg administered daily.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center, University of Texas	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate after 2 cyclesof forodesine therapy.		8 weeks	No