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Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

NCT01466179 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2017-08-18

Study results available
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Summary

The purpose of this study is to confirm whether the bispecific T cell engager antibody blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL).

Conditions

Interventions

BIOLOGICAL

Blinatumomab

Continuous intravenous infusion over four weeks per treatment cycle

Sponsors & Collaborators

  • Amgen Research (Munich) GmbH

    lead INDUSTRY

Principal Investigators

  • Nicola Gökbuget, MD · Klinikum der Goethe Universität Frankfurt

  • Max Topp, MD · Julius-Maximilians-Universität, Medizinische Klinik und Poliklinik II, Würzburg

  • Hagop Kantarjian, MD · MD Anderson Cancer Center, Houston, Texas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-10-31
Completion
2017-01-31

Countries

  • United States
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

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 NCT01466179 on ClinicalTrials.gov