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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leukemia, Lymphocytic, Chronic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MD Anderson Cancer Center, University of Texas

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

forodesine hydrochloride (BCX-1777)

Drug

experimental, forodesine oral dose 200 mg administered daily.

Primary outcomes

Response rate after 2 cyclesof forodesine therapy.

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

BioCryst Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2009
First posted: Feb 10, 2006
Registry last updated: Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed