Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia (CLL)

In brief

To evaluate the effectiveness and safety of forodesine in CLL patients

Key facts

Study ID

NCT00640523

Run by

BioCryst Pharmaceuticals

People needed

23

Starts

2008-03-01

Expected to finish

2011-11-01

Last updated by the study team

2012-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years and older
• Diagnosis of CLL established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
• Subjects with Rai stage III or IV, or earlier stage requiring therapy as determined by the 1996 National Cancer Institute -Working Group (NCI-WG) criterion
• Primary resistant (no CR or PR) or progressive disease after response to at least one prior treatment regimen OR treatment naïve subjects who meet at least one of the following criteria.
• age >65 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4
• Inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.
• ECOG performance status of 0, 1, or 2 (for subjects with primary resistance or progressive disease after response to at least one prior treatment regimen).
• Willing to take adequate contraceptive measures (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after, except for patients who are post menopausal or have prior hysterectomy.
• All investigational treatments should have been discontinued for at least 3 weeks prior to the initiation of the study drug.

You may not qualify if…

• 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 >2 (except for treatment naïve subjects where ECOG performance status 0, 1 or 5 is excluded).
• Inadequate renal function: creatinine > or equal to 2.0 unless related to the disease.
• Inadequate liver function: bilirubin > or equal to 3.0; transaminases > or equal to 3.0 times the upper limit of normal unless related to the disease.
• Known positive test for human immunodeficiency virus (HIV).
• Subjects with known hepatitis B and/or hepatitis C active infection.

Where it is running

• Tower Cancer Research Foundation — Beverly Hills, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Indiana University Cancer Pavillion — Indianapolis, Indiana, United States
• Center for Cancer & Blood Disorders, PC — Bethesda, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia
• Frankston Hospital — Frankston, Victoria, Australia
• Cabrini Hospital — Malvern, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.