A Phase I Study of 8-Chloro-Adenosine in Previously Treated Patients With Chronic Lymphocytic Leukemia.
8-Chloro-adenosine is a new drug similar to other drugs already approved by the FDA for the
treatment of CLL and other types of cancer. 8-Chloro-adenosine belongs to a class of
chemotherapy drugs called purine analogues that work to treat cancer by their ability to
interfere with cancer cell metabolism, causing cell death.
If you are eligible, you will receive 8-chloro-adenosine as an infusion into a vein once a
day for five days in a row. Each infusion will take about 1 hour. This 5-day treatment
will be repeated every 4 weeks (± 3 days) (1 course).
This is a dose escalation study. Patients treated on this study will be treated in groups
of 3. The first group will receive the lowest dose of the drug. If the type, number, and
severity of any side effects experienced are acceptable, the next group of 3 patients will
receive the next higher dose of drug. The dose of drug will be increased for each new group
until the highest safe dose is found.
For your first course only, you will have blood tests (about 1 tablespoon) on Day 3 and Day
5 of treatment to monitor for safety. After that, you will have weekly (± 3 days)
evaluations and routine blood tests (about 1 tablespoon) in the clinic at UTMDACC. During
these evaluations, you will also have a physical exam and be asked about any side effects
you may have experienced. You will be evaluated for improvement in your CLL. If your
disease is stable or responding to treatment, you may continue with treatment. If your
disease improves to the point that your doctor feels that you are in complete remission, he
or she will request you to have a bone marrow biopsy to confirm complete remission.
If your disease is worsening and it appears that the treatment is not helping you, then you
will stop treatment with 8-chloro-adenosine and may begin other treatment at the direction
of your treating doctor. If you have unacceptable side effects, you may be taken off
If you stop treatment, you will be evaluated in the clinic and have routine blood tests
(about 1 tablespoon) once a week for the first month, twice a month for the next 2 months,
then once a month from then on. During these evaluations, you will have a physical exam
and be asked about any side effects you may have experienced. If you begin other treatment,
your scheduled follow-up will end.
This is an investigational study. 8-Chloro-adenosine is not approved by the FDA and is not
commercially available. A total of up to 28 patients will take part in this study. All will
be enrolled and treated at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting Toxicity and Maximum Tolerated Dose
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.
William G. Wierda, M.D.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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