NCT01062152

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

Phase 1 Dose-Ranging Study of Ezatiostat Hydrochloride (Telintra®, TLK199 Tablets)in Combination With Lenalidomide (Revlimid®)in Patients With Non-Deletion(5q) Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Telik · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Ezatiostat Hydrochloride	Starting dose 2000 mg orally in divided doses twice daily (1000 mg in AM \& 1000 mg in PM) x 21 days with one week off therapy in a 4-week cycle.
DRUG	Lenalidomide (Revlimid®)	10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-11-01
• Completion: 2013-03-01
• First posted: 2010-02-04
• Last updated: 2013-06-06

Locations

9 sites across 1 country: United States