Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Inclusion criteria

• Histologic diagnosis of primary or de novo MDS using WHO classification
• Non-del(5q) low or Intermediate-1risk MDS
• ECOG performance status of 0-1
• Documented significant cytopenia for at least 2 months
• Must have discontinued growth factors (EPO, G-CSF, GM-CSF) for at least 21 days prior to study entry
• All study participants must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist®
• Females of childbearing potential should have two negative serum pregnancy tests with a sensitivity of at least 50 mIU/mL. The first test should be performed within 10-14 days, and the second test within 24 hours of prescribing lenalidomide (prescriptions must be filled within seven days)

Exclusion criteria

• Known hypersensitivity to Telintra™ (intravenous or oral)
• Known prior therapy with or hypersensitivity to thalidomide or lenalidomide
• Prior allogenic bone marrow transplant for MDS
• History or prior malignancy

• Except for treated carcinoma of uterine cervix, basal cell or squamous cell skin cancer, or other cancers (e.g. breast, prostate) for which patient has been disease-free for at least 3 years.
• MDS evolving from:

• A pre-existing myeloproliferative disorder
• An autoimmune disease
• Secondary to prior treatment with radiation or chemotherapy
• History of MDS IPSS score>1.0
• Pregnant or lactating women
• Leptomeningeal or leukemic meningitis
• Prior treatment with DNA methyltransferase inhibitors (DMTI) [e.g., azacitadine, decitabine, etc.]