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

Completed · Phase 1

Conditions studied: Myelodysplastic Syndrome

In brief

This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS. The HI-E, HI-N, HI-P rates \[by International Working Group (IWG) 2006 criteria\] and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat in combination with lenalidomide for future studies.

Key facts

Study ID

NCT01062152

Run by

Telik

People needed

19

Starts

2009-11-01

Expected to finish

2013-03-01

Last updated by the study team

2013-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.]

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• Loyola University Chicago Cardinal Benardin Cancer Center — Maywood, Illinois, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• MDAnderson — Houston, Texas, United States
• Cancer Care Centers of South Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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