Lenalidomide After Allo-Hematopoietic Cell Transplant (HCT) in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) Subjects With Minimal Residual Disease

Inclusion criteria

• ✓. Subjects must be at least 18 years of age;
• ✓. Subjects must be post-allogeneic transplant from any donor source;
• ✓. Subjects must have either:
• ✓. High risk CD34+ AML (de novo or secondary, and any WHO 2008 classification excluding acute promyelocytic leukemia). High risk AML is defined as (a) disease status beyond complete remission (CR) #1 at transplant or (b) treatment related AML or (c) presence of adverse cytogenetics including inv(3); t(3;3); t(6;9); t(v;11); -5 or del(5q); -7; abnl(17p) or complex karyotype; or
• ✓. High risk CD34+ MDS (WHO 2008 classification). High risk is defined as (a) blast count ≥5% at the time of transplant or (b) treatment related MD or (c) presence of adverse cytogenetics including -7/del7q or complex karyotype;
• ✓. For AML subjects, they must have a documented CR within 45 days prior to allo-HCT;
• ✓. For MDS subjects, they must have \< 20% myeloblasts in the bone marrow within 45 days prior to allo-HCT;
• ✓. Subject Karnofsky performance status must be ≥ 70;

Exclusion criteria