Overview

8-Chloro-Adenosine in Chronic Lymphocytic Leukemia

Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
FDA Office of Orphan Products Development
National Cancer Institute (NCI)
Treatments:
Adenosine
Criteria
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 paraproteinemia.

3. All patients must have a Zubrod performance status of
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 upper limits of normal (ULN) and adequate liver function indicated by ALT or AST 2.5x ULN AND total bilirubin
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.