A Phase II Trial of Revlimid® (Lenalidomide) and Low Dose Vidaza® (Azacitidine) in Patients With Low - Intermediate-1 Risk Myelodysplastic Syndromes
1. Understand and voluntarily sign an informed consent form.
2. Age 18 years at the time of signing the informed consent form.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Diagnosis of low- or intermediate-1-risk IPSS (see Appendix III) MDS without an
abnormality of chromosome 5 involving a deletion between bands q31 and q33.
Pathologic diagnosis via pathology performed at Rush University Medical Center or made
available to Rush from outside institution.
5. Prior treatment with < 3 cycles (84 days) of Revlimid® (lenalidomide) are eligible for
enrollment regardless of response.
6. ECOG performance status of 2 at study entry (see Appendix II).
7. Disease free of prior malignancies for > 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or
8. Serum bilirubin levels < 1.5 times the upper limit of the normal range for the
laboratory (ULN). Higher levels are acceptable if these can be attributed to active
hemolysis or ineffective erythropoiesis.
9. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2
10. Serum creatinine levels < 1.5 x ULN
11. Absolute neutrophil count > 1000/mm³
12. Platelet count > 30,000/mm³
13. All study participants must be registered into the mandatory RevAssist® program, and be
willing and able to comply with the requirements of RevAssist®.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety and tolerability of revlimid and azacitidine combination
To determine the number of subjects who develop grade 4 toxicity while on combination therapy.
2 -3 years
United States: Food and Drug Administration
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