8-Chloro-Adenosine in Chronic Lymphocytic Leukemia
Completed · Phase 1
Conditions studied: Leukemia, Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT00714103
- Run by
- M.D. Anderson Cancer Center
- People needed
- 11
- Starts
- 2008-06-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-10-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- 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.
- All patients must have a Zubrod performance status of </= 2.
- All patients must be age >/= 18 years.
- 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.
- 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.
- 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.
- All patients or appropriate surrogate must provide informed consent.
You may not qualify if…
- Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.
- Patients with active uncontrolled fungal, bacterial, or viral infection.
- Patients who are pregnant or breast-feeding.
Where it is running
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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