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Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

NCT01471782 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2017-02-08

Study results available
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Summary

The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.

Conditions

Interventions

BIOLOGICAL

Blinatumomab

Administered by continuous intravenous infusion

Sponsors & Collaborators

  • Amgen Research (Munich) GmbH

    lead INDUSTRY

Principal Investigators

  • Arend von Stackelberg, MD · Charite University, Berlin, Germany

  • Lia Gore, MD · Children's Hospital Denver, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-08-31
Completion
2016-05-31

Countries

  • United States
  • Austria
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01471782 on ClinicalTrials.gov