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Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

NCT01207388 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2020-02-10

Study results available
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Summary

The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

Conditions

Interventions

DRUG

Blinatumomab

Continuous intravenous infusion

Sponsors & Collaborators

  • Amgen Research (Munich) GmbH

    lead INDUSTRY

Principal Investigators

  • Ralf Bargou, MD · Medizinische Klinik und Poliklinik II, Würzburg

  • Nicola Gökbuget, MD · Klinikum der Goethe Universität Frankfurt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-02-28
Completion
2019-01-07

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Spain
  • United Kingdom

Study Locations

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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 NCT01207388 on ClinicalTrials.gov