Clareo Health | Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Telik
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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) \[e.g., azacitadine, decitabine, etc.\]
