Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome
NCT01422486 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2013-11-25
Summary
Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS).
Conditions
- Myelodysplastic Syndrome (MDS)
Interventions
- DRUG
-
ezatiostat hydrochloride (Telintra®)
Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.
Sponsors & Collaborators
-
Telik
lead INDUSTRY
Principal Investigators
-
Gail L Brown, MD · Telik
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2013-02-28
- Completion
- 2013-02-28
Countries
- United States
Study Locations
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