Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Rationale:
Lenalidomide has properties of thalidomide and appears to have some activity against cancer
in laboratory tests. Researchers are still learning how lenalidomide works against cancer in
patients. Some ways that this drug seems to produce anti-cancer effects include through
stimulating the immune system and blocking blood vessels contributing to cancer growth. The
current study will explore different dose levels in patients to gather more information about
lenalidomide.
Purpose:
This study will assess the maximum tolerated dose of lenalidomide in patients with relapsed
or refractory acute leukemias and chronic lymphocytic leukemias. Toxicity or side effects
within patients will also be evaluated. Other purposes of this study include analyzing
preliminary clinical activity, pharmacokinetics, and pharmacodynamics. Pharmacokinetics
refers to the activity of drugs in the body over a period of time, including how drugs are
absorbed, distributed, localized in tissues, and excreted. Pharmacodynamics refers to the
bodily processes that lead the drug to effect cancer and other cellular components in the
body.
Treatment:
Study participants will be given lenalidomide through intravenous infusions once every 28
days. A 28-day period constitutes a cycle. Since this study will assess the maximum tolerated
dose of lenalidomide, some study participants will receive different amounts of this drug
compared to others depending upon when each individual enrolls in the study. Each group of 3
to 6 study participants will receive a higher dose of lenalidomide until the maximum
tolerated dose is established. Several tests will be performed throughout the study,
including bone marrow biopsies. Imaging exams will be conducted as well. Treatments will be
discontinued due to disease growth or intolerable adverse effects. Lenalidomide
administration will be repeated for 12 or more cycles in patients that experience clinical
benefit.
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