Lenalidomide After Allo-Hematopoietic Cell Transplant (HCT) in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) Subjects With Minimal Residual Disease
Condition: Leukemia, Myeloid; Myelodysplastic Syndromes
MeSH terms: Leukemia; Preleukemia; Neoplasm, Residual; Leukemia, Myeloid; Myelodysplastic Syndromes; Syndrome
Intervention: Lenalidomide
Intervention description: Subjects will be enrolled in cohorts of three (3). Lenalidomide will be administered for 21 consecutive days in a 28 day cycle X 2 cycles. The starting dose will be 2.5 mg given orally every other day for 21 days.
Intervention MeSH terms: Lenalidomide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lenalidomide; Hematopoietic Stem Cell Transplantation; Peripheral Blood Stem Cell Transplantation

Summary:

      The purpose of this study is to determine the maximum tolerated dose, dose limiting side
      effects, and the safety of increasing doses of lenalidomide in patients with AML and MDS who
      have a small amount of detectable disease after allogeneic stem cell transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be at least 18 years of age;

          2. Subjects must be post-allogeneic transplant from any donor source;

          3. Subjects must have either:

               1. 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

               2. 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;

          4. For AML subjects, they must have a documented CR within 45 days prior to allo-HCT;

          5. For MDS subjects, they must have < 20% myeloblasts in the bone marrow within 45 days
             prior to allo-HCT;

          6. Subject Karnofsky performance status must be ≥ 70;

          7. Subjects must be platelet transfusion independent (Platelet transfusion independence
             is defined as 7 days or greater without a platelet transfusion);

          8. Neutrophil count ≥ 1.0 thou/mm3 and platelet count ≥ 30 thou/mm3;

          9. Subjects must have total bilirubin ≤ 2 mg/dL;

         10. Subjects must have serum AST and ALT levels ≤ 2.5 times upper limit of normal;

         11. Subjects must have serum creatinine < 2.5 times upper limit of normal and a calculated
             creatinine clearance > 30 ml/min by Cockcroft-Gault formula (see Appendix I:
             Cockcroft-Gault Creatinine Clearance Calculation);

         12. All study participants who will receive lenalidomide based on the CD34+ chimerism
             testing must be registered into the mandatory Revlimid REMS® program, and be willing
             and able to comply with the requirements of the REMS® program;

         13. Females of child-bearing potential (i.e., women who are premenopausal or not
             surgically sterile) may participate, provided they meet the following conditions:

             a) Females of reproductive potential must adhere to the scheduled pregnancy testing as
             required in the Revlimid REMS® program; and

         14. Written, voluntary informed consent, willingness, and ability to comply with all study
             procedures.

        Exclusion Criteria:

          1. CD34- AML or MDS;

          2. Inability to give informed consent;

          3. Uncontrolled active infection(s) requiring intravenous antibiotics;

          4. Known or suspected hypersensitivity to lenalidomide;

          5. Grade II-IV acute GVHD or extensive GVHD;

          6. Not able to swallow the lenalidomide capsule as a whole;

          7. Female subjects who are pregnant or nursing.