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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640523
• Other study ID #: BCX1777-210
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2008
• Last updated: January 18, 2012
• Start date: March 2008
• Est. completion date: November 2011

Study information

• Verified date: January 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

To evaluate the effectiveness and safety of forodesine in CLL patients

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• forodesine HCl
2 x 100mg capsules daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Up to 6 cycles of therapy	No