Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia

Phase 2 Completed 149 enrolled GIMEMA Foundation

NaSingle-groupOpen-labelTreatment

Summary

The present study aims at analyzing the response to treatment of adult patients homogeneously treated with supportive care, chemotherapy and blinatumomab.

Timeline

Start: 2018-06-08
Primary completion: 2024-09-02
Completion: 2024-09-02

Outcome

Met primary endpoint

paper MRD negativity increased from 72% to 93% (P < .001) after blinatumomab PMID 40009490 ↗

paper 23 of 30 MRD-positive patients (73%) becoming MRD negative, fulfilling the primary end point. PMID 40009490 ↗

Publications

Bassan R, Chiaretti S, Della Starza I, Santoro A, Spinelli O, Tosi M, Elia L, Cardinali D, De Propris MS, Piccini M, Lussana F, Annunziata M, Chiusolo P, Zappasodi P, Borlenghi E, Leoncin M, Califano C, Bocchia M, Di Raimondo F, Grimaldi F, Tiribelli M, Candoni A, Lico A, Audisio E, Lunghi M, Mianulli AM, Di Trani M, Arena V, Messina M, Piciocchi A, Fazi P, Rambaldi A, Foa R. Up-front blinatumomab improves MRD clearance and outcome in adult Ph- B-lineage ALL: the GIMEMA LAL2317 phase 2 study. Blood. 2025 May 22;145(21):2447-2459. doi: 10.1182/blood.2024027500.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Blinatumomab	Monoclonal antibody	—	—