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

• Conditions: Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

• Registration Number: NCT02187354
• Lead Sponsor: Amgen

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sheffield, United Kingdom