drugset / Trial / NCT01523782

Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia

NCT01523782

Phase 2 Completed 30 enrolled ERYtech Pharma
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to determine the maximum tolerated and efficient dose of GRASPA® in combination with polychemotherapy treatment of elderly patients with ALL, 55 years and over, Philadelphia chromosome-negative (ALL Ph-).

Timeline

Start
2009-04
Primary completion
2011-01
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject GRASPA Protein / enzyme biologic 50 iu/kg
Subject GRASPA Protein / enzyme biologic 100 iu/kg
Subject GRASPA Protein / enzyme biologic 150 iu/kg