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

• Status: Terminated
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Celgene Corporation
• Treatments: Lenalidomide; Thalidomide

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.