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SPARK-ALL: Calaspargase Pegol in Adults With Newly-diagnosed Philadelphia-negative ALL

NCT04817761Phase 3

Key facts

Status: Terminated
Start: Jul 2021
Primary completion: Apr 2025
Countries: 1
Sponsor: Servier
Modality: Replacement Enzymes

Drugs: calaspargase pegol
Conditions: acute lymphoblastic leukemia (ALL)

Overview

Phase 3, open-label, single-arm trial of calaspargase pegol in acute lymphoblastic leukemia (ALL), sponsored by Servier. Primary endpoints: Adverse Events at 3.5 years, Plasma Asparaginase Activity Level at 21 days and 1 more. Started Jul 2021; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Calaspargase pegol (S95015)
Calaspargase pegol administered via IV infusion along with CALGB 10403 protocol chemotherapy.

Who it enrols

Adults >=22 years with newly-diagnosed Philadelphia-negative ALL, ECOG 0-2, no prior therapy. Excludes Ph+ ALL, Down syndrome, HIV, Hep B/C, severe hepatic impairment, and BMI > 35 kg/m2 (Part 2).

Endpoints

Primary

Adverse Events3.5 years
Plasma Asparaginase Activity Level21 days
Nadir Plasma Asparaginase ActivityDay 64

Secondary

Number of Participants With Plasma Asparaginase Activity Level >=0.1 U/mLDay 0-203
Plasma Asparaginase Activity Level >=0.025 U/mL21 days
Plasma Asparaginase Activity Level >=0.2 U/mL21 days
Plasma Asparaginase Activity Level >=0.4 U/mL21 days
PAA-derived Maximum ConcentrationDay 4-25
PAA-derived Area Under the PAA-Time Curve From Time 0 to Day 35Day 0-35
Minimal Residual DiseaseDay 29
Complete RemissionDay 29

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