Clinical trial · Interventional
Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
Phase II Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-Refractory Chronic Lymphocytic Leukemia (CLL)
NCT00289549CI-TRIAL-00006229completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| forodesine hydrochloride (BCX-1777) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate after 2 cyclesof forodesine therapy.
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBalakrishnan 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. PMID 20427701