Clinical trial · Interventional
8-Chloro-Adenosine in Chronic Lymphocytic Leukemia
A Phase I Study of 8-Chloro-Adenosine in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
NCT00714103CI-TRIAL-00024261completedPhase 1ClinicalTrials.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)
The goal of this clinical research study is to find the highest safe dose of the drug 8-chloro-adenosine that can be given in the treatment of chronic lymphocytic leukemia (CLL). Another goal is to learn how effective the drug is at treating leukemia.
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 |
|---|---|---|---|
| 8-Chloro-Adenosine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 8-Chloro-Adenosine
- description
- Starting dose for first cohort of patients 45 mg/m2 intravenous over 1 hr daily for 5 days every 4 weeks (± 3 days).
- interventionNames
- Drug: 8-Chloro-Adenosine
Primary outcomes (1)
- measure
- Dose-limiting Toxicity and Maximum Tolerated Dose
- timeFrame
- 4 weeks
- description
- During first course of treatment blood tests on Days 3 and 5; then weekly (± 3 days) evaluations and routine blood tests. Toxicity evaluation completed four weeks following initial 8-Chloro-adenosine administration.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment. 2. Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more criteria for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time \</= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia. 3. All patients must have a Zubrod performance status of \</= 2. 4. All patients must be age \>/= 18 years. 5. Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy. 6. All patients must have adequate renal function indicated by serum creatinine \</=2.5x upper limits of normal (ULN) and adequate liver function indicated by ALT or AST \</= 2.5x ULN AND total bilirubin \</= 2.5x ULN. 7. All patients must have a pre-treatment platelet count of \>/= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease. 8. All patients or appropriate surrogate must provide informed consent. Exclusion Criteria: 1. Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura. 2. Patients with active uncontrolled fungal, bacterial, or viral infection. 3. Patients who are pregnant or breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.