Clinical trial · Interventional
Oral Clofarabine in Chronic Lymphocytic Leukemia (CLL)
Phase I Study of Oral Clofarabine for the Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
NCT00800566CI-TRIAL-00007680withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor terminated.
Summary
Brief summary (as posted)
The goal of this clinical research study is to find the highest tolerable dose of clofarabine when given to patients with CLL. The safety of this drug will also be studied.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral Clofarabine
- interventionNames
- Drug: Oral Clofarabine
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) and Dose limiting toxicities (DLT)
- timeFrame
- October 2009
Secondary outcomes (1)
- measure
- To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile in CLL.
- timeFrame
- October 2010
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB \[French-American-British Classification\]), small lymphocytic lymphoma (SLL) and prolymphocytic leukemia (PLL) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens. * Absolute neutrophil count (ANC) \>= 1 x 109/L and platelet count \>= 50 x 109/L. * Adequate organ function as indicated by the following laboratory values: serum creatinine \</= 1 mg/dL; if serum creatinine \> 1 mg/dL, then the estimated glomerular filtration rate (GFR) must be \> 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation; serum bilirubin \</= 1.5 mg/dL x ULN; aspartate transaminase (AST)or alanine transaminase (ALT) \</= 2.5 x ULN; alkaline phosphatase \</= 2.5 x ULN. * ECOG performance status \<= 2. * Age \>/= 18 years. Exclusion Criteria: * Patients with NYHA \>/= grade 3 heart disease as assessed by history and/or physical examination. * Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception. Positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization). * Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy). * Other malignancy within 3 years except in situ carcinoma. * Unwilling or unable to provide informed consent. * Known hypersensitivity to nucleoside analogues. * Any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known hepatitis.
References
Publications (0)
Data not yet available
No reference posted for this study.