Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL

• Status: No longer available
• Trial end date: 1969-12-31

Summary

Primary Objective:

To estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to other treatments

Secondary Objective(s):

To describe key efficacy outcomes, including incidence of complete response (CR) within 2 cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and 100-day mortality after alloHSCT.

Hypotheses:

A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and treatment-related adverse events will be estimated.

Study Endpoints:

• Incidence of treatment-emergent and treatment-related adverse events

• Incidence of CR within 2 cycles of blinatumomab

• MRD remission within 2 cycles of blinatumomab

• RFS

• OS

• Incidence of alloHSCT

• 100-day mortality after alloHSCT

Study Design:

Multi-center, open-label, single-arm expanded access protocol

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Bispecific; Blinatumomab