NCT00542828

Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome

A Phase II Study of the Efficacy of Rabbit Anti-thymocyte Globulin (rATG) in Patients With Low and Intermediate-1 Risk Myelodysplastic Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, single-arm, open-label, multinational, multicenter study of rATG in patients with low or intermediate-1 risk MDS who have either failed 1 prior treatment with growth factor(s), hypomethylating agents (5-azacitidine or decitabine), or the antiangiogenic agents lenalidomide or thalidomide, or who have never been treated for MDS (i.e., treatment-naïve patients).

Conditions

• Myelodysplastic Syndrome (MDS)

Interventions

Type	Name	Description
BIOLOGICAL	Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG)	All patients were to be treated with rATG 3.75 mg/kg/day administered by intravenous (IV) infusion over ≥6 hours for 5 consecutive days (cumulative dose: 18.75 mg/kg)

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-05-01
• Completion: 2009-07-01
• First posted: 2007-10-12
• Last updated: 2015-04-03
• Results posted: 2010-04-27

Locations

7 sites across 4 countries: France, Germany, Netherlands, United Kingdom