Protocol Title: Phase II trial of High Dose Lenalidomide in Patients with MDS and AML with Trilineage Dysplasia (AML-TLD)
The primary endpoint is hematologic response rate (defined by IWG 2006 response criteria) following administration of 2 - 4 cycles of lenalidomide 15 mg. Response will be assessed following administration of two 42 day treatment cycles. To determine and describe toxicity of higher doses of lenalidomide in patients with MDS and AML-TLD who do not harbor the 5q31.1.deletion and those who have such a deletion but have failed to respond to standard dose lenalidomide
Inclusion Criteria: Age greater than18 years at the time of signing the informed consent form. Able to adhere to the study visit schedule and other protocol requirements. MDS or MDS/AML Patients must not have received any other treatment for their disease, including hematopoietic growth factors, within three weeks of beginning the trial ECOG performance status of 0, 1, or 2 at study entry All study participants must be registered into the mandatory RevAssistÂ® program, and be willing and able to comply with the requirements of RevAssistÂ®. Patients must have no clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia. Subjects must agree to use appropriate contraception. Exclusion Criteria: Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. Use of any other experimental drug or therapy within 21 days of baseline. Known hypersensitivity to thalidomide. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. Any prior use of lenalidomide except for MDS patients with del 5q31.1 abnormalities.. Concurrent use of other anti-cancer agents or treatments. Patients may not have received prior AML induction chemotherapy or stem cell transplant. However, patients with secondary MDS who have received a stem cell transplant for other indications (eg lymphoma, multiple myeloma) will be eligible.
Lenalidomide 15 mg PO daily on days 1 - 28 out of a 42 day cycle for 4 cycles.
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