Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT00640523
Last Updated: 2012-01-23
Study Results
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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COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2008-03-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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forodesine HCl
2 x 100mg capsules daily
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of CLL established by peripheral blood and/or bone marrow examination and using the standard diagnostic criteria.
3. 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
4. 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.
1. age \>65 years
2. Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4
3. Inability to tolerate standard cytotoxic chemotherapy in the opinion of the treating physician.
5. 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).
6. 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.
7. All investigational treatments should have been discontinued for at least 3 weeks prior to the initiation of the study drug.
Exclusion Criteria
2. Unable or unwilling to sign consent.
3. Severe, ongoing co-morbid conditions, which would preclude safe delivery of the investigational therapy.
4. Active serious infections that are not controlled by antibiotics.
5. ECOG performance status \>2 (except for treatment naïve subjects where ECOG performance status 0, 1 or 5 is excluded).
6. Inadequate renal function: creatinine \> or equal to 2.0 unless related to the disease.
7. 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.
8. Known positive test for human immunodeficiency virus (HIV).
9. Subjects with known hepatitis B and/or hepatitis C active infection.
18 Years
ALL
No
Sponsors
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BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Asher Chanan-Khan, MD
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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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
Countries
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Other Identifiers
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BCX1777-210
Identifier Type: -
Identifier Source: org_study_id
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