Trial intelligence / Profile preview

GRASPA vs L-asparaginase in Relapsed ALL

NCT01518517Phase 3

Key facts

Status: Completed
Start: Dec 2009
Primary completion: Sep 2014
Countries: 2
Sponsor: PHAXIAM Therapeutics
Modality: Replacement Enzymes

Drugs: eryaspase
Conditions: acute lymphoblastic leukemia (ALL)

Overview

Phase 3, randomised, open-label trial of eryaspase in acute lymphoblastic leukemia (ALL) (3 arms), sponsored by PHAXIAM Therapeutics. Primary endpoints: Duration of Asparaginase Activity >100 U/L During Induction at 28 days and Incidence of Asparaginase Hypersensitivity During Induction at 28 days. Started Dec 2009; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

GRASPA (Randomized)
Eryaspase 150 IU/kg + COOPRALL (Non-hypersensitive patients)
Reference L-asparaginase
Native L-asparaginase 10,000 IU/m2 + COOPRALL (Non-hypersensitive patients)
GRASPA (Exploratory)
Eryaspase 150 IU/kg + COOPRALL (Hypersensitive patients)

Who it enrols

Patients 1-55 years old with first relapse of Philadelphia-negative ALL, previously treated with L-asparaginase. Excludes severe cardiac impairment, pancreatitis history, and Grade 4 allergy to E. coli L-asparaginase.

Endpoints

Primary

Duration of Asparaginase Activity >100 U/L During Induction28 days
Incidence of Asparaginase Hypersensitivity During Induction28 days

Secondary

Complete Remission28 days
Minimal Residual Disease28 days
Event Free Survival36 months
Overall Survival36 months

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