Clinical trial · Interventional
Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia
Phase I Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia
NCT00081887CI-TRIAL-00007697terminatedPhase 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): low accrual
Summary
Brief summary (as posted)
Primary Objectives: 1. To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL). 2. To determine the toxicity profile of clofarabine in CLL. 3. To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL.
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 |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Weekly Clofarabine
- interventionNames
- Drug: Clofarabine
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Following each 4 week treatment cycle
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB), and PLL (B- and T-cell phenotypes) who have relapsed from or are refractory to at least one fludarabine-based regimen. 2. Absolute neutrophil count (ANC) \>= 1 x 10(9)/L and platelet count \>= 50 x 10(9)/L 3. Adequate liver function (total bilirubin \<= 1.5 x ULN, SGPT \<= 2.5 x ULN) and renal function (serum creatine \<= 1.5 x ULN). 4. ECOG performance status \<= 2. Exclusion Criteria: 1. Patients with NYHA \>= grade 3 heart disease as assessed by history and/or physical examination 2. Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception. 3. Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy) 4. Other malignancy within 3 years except in situ carcinoma 5. Unwilling or unable to provide informed consent 6. Hypersensitivity to nucleoside analogues 7. Other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within 6 months, ventricular arrhythmia, diabetes, active infection, pulmonary fibrosis, and chronic hepatitis
References
Publications (0)
Data not yet available
No reference posted for this study.