In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase IBiomarker/Laboratory analysis, TreatmentActive18 and underPharmaceutical / IndustryMT103-205
2010-024264-18, NCT01471782

Trial Description

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.

Further Study Information

Relapsed/refractory B-precursor ALL in pediatric and adolescent patients is an aggressive malignant disease with dismal prognosis. Apart from allogeneic hematological stem cell transplantation (HSCT) there is not any other curative treatment of second relapse or refractory B-precursor ALL available. Additional therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. The purpose of this study is to investigate the pharmacokinetics, pharmacodynamics and safety of escalating doses of the BiTE® antibody blinatumomab (MT103)in pediatric and adolescent patients with relapsed/refractory B-precursor ALL, to select a dose and to investigate the efficacy and safety of that dose of blinatumomab in above mentioned patient population. Patients will receive up to five 6-weeks cycles (4 weeks of continuous intravenous infusion followed by a 2-weeks treatment free interval) of blinatumomab treatment.

Eligibility Criteria

Inclusion Criteria:

  • Morphologic evidence of B-precursor ALL with > 25% blasts in bone marrow (M3)at study enrolment
  • Age less than 18 years at enrollment
  • Relapsed/refractory disease:
  • Second or later bone marrow relapse,
  • Any marrow relapse after allogeneic HSCT, or
  • Refractory to other treatments: Patients in first relapse must have failed to achieve a CR following full standard reinduction chemotherapy regimen of at least 4 weeks duration.Patients who have not achieved a first remission must have failed a full standard induction regimen
  • Karnofsky performance status more than or equal to 50% for patients more than or equal to 16 years and Lansky Performance Status (LPS) of more than or equal to 50% for patients less than 16 years
  • Organ function requirements: All patients must have adequate renal and liver functions

Exclusion Criteria:

  • Active acute or extensive chronic GvHD
  • Immunosuppressive agents to prevent or treat GvHD within 2 weeks prior to blinatumomab treatment
  • Evidence for current CNS involvement by ALL (CNS 2, CNS 3) or testicular involvement by ALL
  • History of relevant CNS pathology or current relevant CNS pathology
  • History of autoimmune disease with potential CNS involvement or current autoimmune disease
  • Any HSCT within 3 months prior to blinatumomab treatment
  • Cancer chemotherapy within 2 weeks prior to blinatumomab treatment (except for intrathecal chemotherapy and/or low dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, glucocorticoids)
  • Chemotherapy related toxicities that haven't resolved to less than or equal to Grade 2
  • Radiotherapy within 2 weeks prior to blinatumomab treatment
  • Immunotherapy (e.g. rituximab, alemtuzumab) within 6 weeks prior to blinatumomab treatment
  • Any investigational product within 4 weeks prior to study entry
  • Previous treatment with blinatumomab
  • Active severe infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
  • Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive)

Trial Contact Information

Trial Lead Organizations/Sponsors

Amgen GmbH

Arend von Stackelberg, MDStudy Chair

Lia GoreStudy Chair

Trial Sites

U.S.A.
Colorado
  Aurora
 Children's Hospital Colorado Center for Cancer and Blood Disorders
 Lia Gore, MD
  Email: lia.gore@ucdenver.edu
Georgia
  Atlanta
 AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
 todd M Cooper, MD
  Email: todd.cooper@choa.org
Missouri
  ST. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Robert Hayashi, MD
  Email: hayashi_r@kids.wustl.edu
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Tanya M Trippet, MD
  Email: trippet1@mskcc.org
Ohio
  Cincinnati
 Cincinnati Children's Hospital Medical Center
 Maureen O'Brien, MD
  Email: maureen.obrien@cchmc.org
Pennsylvania
  Philadelphia
 Children's Hospital of Philadelphia
 Susan R Rheingold, MD
  Email: rheingold@email.chop.edu
Tennessee
  Memphis
 St. Jude Children's Research Hospital
 Deepa Bhojwani, MD
  Email: Deepa.Bhojwani@stjude.org
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Naomi J Winick, MD
  Email: naomi.winick@utsouthwestern.edu
  Houston
 Dan L. Duncan Cancer Center at Baylor College of Medicine
 Terzah M Horton, MD
  Email: tmhorton@txccc.org
Utah
  Salt Lake City
 Primary Children's Medical Center
 Phillip Barnette, MD
  Email: phillip.barnette@imail.org
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Blythe Thomson, MD
  Email: blythe.thomson@seattlechildrens.org
Austria
  Vienna
 St. Anna Children's Hospital
 Christina Peters, MD Ph: +43 1 40 170 3106
  Email: christina.peters@stanna.at
France
  Marseille
 Hôpital de la Timone (Enfants)
 Gerard Michel, MD
  Email: gerard.michel@ap-hm.fr
  Paris Cedex 19
 CHU - Robert Debre
 Benoit Brethon, MD
  Email: benoit.brethon@rdb.aphp.fr
Germany
  Berlin
 Charite University Hospital - Campus Virchow Klinikum
 Arend von Stackelberg, MD Ph: +49-30-450666 Ext.833
  Email: arend.stackelberg@charite.de
  Düsseldorf
 Universitaetsklinikum Duesseldorf
 Arndt Borkhardt, MD Ph: +49-211-8117 Ext.680
  Email: arndt.borkhardt@med.uni-duesseldorf.de
  Frankfurt am Main
 Klinikum der J.W. Goethe Universitaet
 Peter Bader, Prof. Ph: +49 69 (0) 6301 7542
  Email: peter.bader@kgu.de
  Hamburg
 University Medical Center Hamburg - Eppendorf
 Martin Horstmann, MD
  Email: horstmann@uke.de
  Kiel
 University Hospital Schleswig-Holstein - Kiel Campus
 Martin Schrappe, MD
  Email: m.schrappe@pediatrics.uni-kiel.de
  München
 Dr. von Haunersches Kinderspital der Universitaet Muenchen
 Michael Albert, MD Ph: +49-89-5160 Ext.2811
  Email: michael.albert@med.uni-muenchen.de
  Tübingen
 Universitaetsklinikum Tuebingen
 Rupert Handgretinger, MD Ph: +49-7071-2984 Ext.744
  Email: rupert.handgretinger@med.uni-tuebingen.de
  Würzburg
 Julius Maximilians Universitaet Hospital
 Paul Gerhardt Schlegel, MD
  Email: schlegel@mail.uni-wuerzburg.de
Italy
  Monza
 Ospedale San Gerardo
 Carmelo Rizzari, MD
  Email: c.rizzari@hsgerardo.org
  Rome
 Ospedale Bambino Gesu
 Franco Locatelli, MD Ph: +39668592678
  Email: franco.locatelli@opbg.net
Netherlands
  Rotterdam
 Erasmus MC - Sophia Children's Hospital
 Christian M Zwaan, MD
  Email: c.m.zwaan@erasmusmc.nl

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01471782
ClinicalTrials.gov processed this data on November 20, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to TopBack to Top