drugset / Trial / NCT03628053

Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia

NCT03628053 ↗

Phase 3 Withdrawn Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial aims to compare the benefits and risks of tisagenlecleucel to blinatumomab or inotuzumab in adult patients with relapsed or refractory ALL. This trial investigates tisagenlecleucel as an additional treatment option for this patient population with high unmet medical need.

Timeline

Start
2020-06-05
Primary completion
2025-10-08
Completion
2026-01-07

Outcome

Outcome not reported

Stopped: “Novartis is no longer pursuing this study because of planned investigation of novel CAR-T therapies in this patient population.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Blinatumomab Monoclonal antibody — —
Comparator Inotuzumab Other / unclassified — —
Subject Tisagenlecleucel Cell therapy — —