Clinical trial NCT00289549: Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
Official title: Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Lymphocytic, Chronic
Keywords: CLL
Chronic lymphocytic leukemia
leukemia
Advanced, fludarabine-refractory CLL
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 8
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: Forodesine hydrochloride will be administered orally at a dose of 200 mg daily for 7 days each week for 4 weeks (cycle number 1). The drug will be administered once daily one hour prior to or two hours after meals. Patients will be evaluated after 1 full cycle of therapy (28 days).


Eligibility criteria: Inclusion Criteria:

* Ages 18 years and older
* Diagnosis of CLL established by peripheral blood and bone marrow examination and using the standard criteria
* Patients with Rai stage III or IV, or earlier stage with massive, symptomatic lymphadenopathy requiring therapy
* Primary resistance to fludarabine-based therapy (no complete response \[CR\] or partial response \[PR\]) or progressive disease within 6 months of response to prior fludarabine containing regimen.
* ECOG performance status of 0, 1, 2 or 3
* Willing to take adequate contraception (i.e. latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study and 3 months after
* All investigational treatments should have been discontinued for at least 1 week prior to the initiation of the study drug.

Exclusion Criteria:

* 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 4
* Inadequate renal function: creatinine 2.0 or more unless related to the disease
* Inadequate liver function: bilirubin 3.0 or more, transaminases 3 x upper limit of normal or more unless related to the disease
* Known positive test for HIV
* Patients with known hepatitis B and/or hepatitis C active infection

Primary outcomes:
measure: Response rate after 2 cyclesof forodesine therapy.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center, University of Texas
state: Texas
Study officials:
affiliation: MD Anderson Cancer Center University of Texas
name: Farhad Ravandi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balakrishnan K, Verma D, O'Brien S, Kilpatrick JM, Chen Y, Tyler BF, Bickel S, Bantia S, Keating MJ, Kantarjian H, Gandhi V, Ravandi F. Phase 2 and pharmacodynamic study of oral forodesine in patients with advanced, fludarabine-treated chronic lymphocytic leukemia. Blood. 2010 Aug 12;116(6):886-92. doi: 10.1182/blood-2010-02-272039. Epub 2010 Apr 28.