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

Phase 2

Completed

• Conditions: Chronic Lymphocytic Leukemia (CLL)

• Registration Number: NCT00640523
• Lead Sponsor: BioCryst Pharmaceuticals

Brief Summary

To evaluate the effectiveness and safety of forodesine in CLL patients

Detailed Description

To investigate the efficacy (complete response \[CR\] + partial response \[PR\]) of forodesine in treating subjects with CLL who have failed at least one prior treatment regimen or who are treatment naïve but are either elderly, have poor performance status or are otherwise predicted not to tolerate cytotoxic chemotherapy.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Primary Completion: 2010-11
• Study Completion: 2011-11
• Status Verified: 2012-01
• Disposition First Submitted: 2012-01-18
• Disposition First Submitted QC: 2012-01-18
• Last Update Submitted: 2012-01-18
• Disposition First Posted: 2012-01-23
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Age 18 years and older

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

1. Pregnant or nursing.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate	Up to 6 cycles of therapy

Trial Locations

Locations (11)

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Royal Brisbane and Women's Hospital; 🇦🇺 Brisbane, Queensland, Australia

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Frankston Hospital; 🇦🇺 Frankston, Victoria, Australia

Tower Cancer Research Foundation; 🇺🇸 Beverly Hills, California, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Center for Cancer & Blood Disorders, PC; 🇺🇸 Bethesda, Maryland, United States

Indiana University Cancer Pavillion; 🇺🇸 Indianapolis, Indiana, United States

Cabrini Hospital; 🇦🇺 Malvern, Victoria, Australia