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

Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Clinical Trial

Official title: An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects With Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Status No longer available

Clinical Trial 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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

• NCT number: NCT02187354
• Study type: Expanded Access
• Source: Amgen
• Status: No longer available