Dose-Ranging Study of Telintra® Tablets + Revlimid® in Patients With Non-Deletion (5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
- Conditions
- Myelodysplastic Syndrome
- Interventions
- Registration Number
- NCT01062152
- Lead Sponsor
- Telik
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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)
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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.]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Revlimid® in Combination with Telintra ® Ezatiostat Hydrochloride Lenalidomide (Revlimid®) followed by Telintra® until MDS progression or lack of efficacy. Revlimid® in Combination with Telintra ® Lenalidomide (Revlimid®) Lenalidomide (Revlimid®) followed by Telintra® until MDS progression or lack of efficacy.
- Primary Outcome Measures
Name Time Method To establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide 2 years To determine the safety of ezatiostat in combination with lenalidomide 2 years
- Secondary Outcome Measures
Name Time Method To determine the efficacy of ezatiosate in combination wiht lenalidomide in patients with non-del(5q) low to intermediate-1 risk of MDS 2 years Hematologic Improvement-Erythroid (HI-E) rate 2 years Hematologic Improvement-Neutrophil (HI-N) rate 2 years Hematologic Improvement-Platelet (HI-P) rate 2 years
Trial Locations
- Locations (9)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Loyola University Chicago Cardinal Benardin Cancer Center
🇺🇸Maywood, Illinois, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
MDAnderson
🇺🇸Houston, Texas, United States