Clinical trial NCT00640523: Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)
Official title: Phase II Study of Forodesine in Subjects With Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia (CLL)
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate
timeFrame: Up to 6 cycles of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Indianapolis
country: United States
facility: Indiana University Cancer Pavillion
state: Indiana
city: Bethesda
country: United States
facility: Center for Cancer & Blood Disorders, PC
state: Maryland
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
Study officials:
affiliation: Roswell Park Cancer Institute
name: Asher Chanan-Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: