A Phase 1 Study of Lenalidomide in Combination with EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL)

Are you 18 years of age or older? Have you been diagnosed with human T-cell leukemia virus (HTLV)-associated adult T-cell leukemia-lymphoma (ATLL)? Are you able to make regularly scheduled visits to the clinic for treatment and examinations?

Are you Eligible? (Inclusion Criteria)

• The purpose of this study is to test the safety and tolerability (side effects)
• of adding a study drug called lenalidomide at different doses in combination
• with the usual treatment with EPOCH chemotherapy. “Dose” is defined as the
• amount of drug a patient gets, such as 15 mg. These drugs have already been
• approved by the FDA for other types of cancer. This study tests different doses
• of the lenalidomide to see which dose is safer and more tolerable for people
• when combined with EPOCH chemotherapy. Another purpose of the study is genetic
• testing using tumor tissue to see if the combination of drugs may work in
• treating specific types of cancer. In addition, another objective of the study
• is to see how the combination of drugs affects HTLV levels and the number of
• immune cells in patients' blood. This is the first time all of these drugs will
• be tested together in patients with HTLV associated adult T-cell leukemia-
• lymphoma (ATLL). There will be about 30 people taking part in this study.