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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier:
NCT01207388
First received: September 21, 2010
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
B-cell Acute Lymphoblastic Leukemia
Drug: Blinatumomab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)

Resource links provided by NLM:


Further study details as provided by Amgen Research (Munich) GmbH:

Primary Outcome Measures:
  • MRD response rate [ Time Frame: within 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hematological relapse-free survival rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Duration of complete MRD response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall incidence and severity of AEs [ Time Frame: until EoS ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: until EoS ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: September 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blinatumomab
single arm
Drug: Blinatumomab
intravenous infusion
Other Names:
  • AMG103
  • MT103

Detailed Description:

The detection of minimal residual disease (MRD) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of adult ALL. No standard treatments are available for patients with MRD-positive B-precursor ALL. Blinatumomab (MT103) 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 confirm whether the bispecific T-cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease. Patients will receive up to four 4-week cycles of intravenous blinatumomab treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with B-precursor ALL in complete hematological remission after at least 3 intense chemotherapy blocks
  • Presence of minimal residual disease at a level of >=10-3
  • Availability of bone marrow specimen from primary diagnosis for clone-specific MRD assessment
  • Negative HIV test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test
  • Negative pregnancy test in women of childbearing potential
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Presence of circulating blasts or current extra-medullary involvement by ALL
  • History of relevant CNS pathology or current CNS pathology
  • Prior allogeneic HSCT
  • Eligibility for treatment with TKIs
  • Systemic cancer chemotherapy within 2 weeks prior to study treatment
  • Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
  • Previous treatment with blinatumomab
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207388

  Hide Study Locations
Locations
Austria
1102 - LKH Graz
Graz, Austria
1107 - Krankenhaus der Elisabethinen
Linz, Austria
1106
Salzburg, Austria
1101 - AKH Wien
Vienna, Austria
Belgium
1504
Antwerpen, Belgium
1502 - Cliniques Universitaires de Saint-Luc
Brussels, Belgium
1505
Brügge, Belgium
1503
Gent, Belgium
1501 - Cliniques Universitaires UCL de Mont Godinne
Yvoir, Belgium
France
1211 - CHU d'Angers
Angers, France
1210 - CHU de Besançon
Besançon, France
1206 - Hôpital de Pontoise
Cergy Pontoise, France
1205 - CHU Henri Mondor
Créteil, France
1209 - CHU de Lyon
Lyon, France
1212 - Hôpital de l'hôtel Dieu
Nantes, France
1213 - Centre Hospitalier Universitaire de Nice
Nice, France
1201 - Hôpital Saint Louis
Paris, France
1202 - CHU de Bordeaux - Hôpital Haut Lévêque
Pessac, France
1208 - CHU de Purpan
Toulouse, France
Germany
1011 - Charité Berlin
Berlin, Germany
1022 - Universitätsklinkum Carl Gustav Carus Dresden
Dresden, Germany
1009 - Universitätsklinikum Essen
Essen, Germany
1002 - Klinikum der Goethe Universität
Frankfurt, Germany
1014 - Asklepiosklinik St. Georg
Hamburg, Germany
1018 - Medizinische Hochschule Hannover
Hannover, Germany
1012 - Universitätsklinikum Heidelberg
Heidelberg, Germany
1003 - Universitätsklinikum Schleswig-Holstein
Kiel, Germany
1019 - Universitätsklinikum Leipzig
Leipzig, Germany
1010 - Klinikum der Universität München - Großhadern
Munich, Germany
1004 - Universitätsklinikum Münster
Münster, Germany
1016 - Universitätsklinikum Regensburg
Regensburg, Germany
1020 - Universitätsklinikum Rostock
Rostock, Germany
1007 - Robert-Bosch-Krankenhaus
Stuttgart, Germany
1015 - Universitätsklinikum Tübingen
Tübingen, Germany
1005 - Universitätsklinikum Ulm
Ulm, Germany
1001 - Julius-Maximilians-Universität Würzburg
Würzburg, Germany
Italy
1301 - Ospedali Riuniti di Bergamo
Bergamo, Italy
1303 - Istituto di Ematologia "L.& A.Seràgnoli" Azienda
Bologna, Italy
1314 - Azienda Ospedaliera Spedali Civili Brescia
Brescia, Italy
1313 - Universita di Catania
Catania, Italy
1312 - Azienda Ospedaliera Universitaria San Martino
Genoa, Italy
1305 - Ospedale San Gerardo
Monza, Italy
1309 - Azienda Ospedaliera Antonio Cardarelli
Napoli, Italy
1308 - Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy
1302 - Università La Sapienza di Roma
Rome, Italy
1310 - Fondazione Policlinico Tor Vergata
Rome, Italy
1315 - Azienda Ospedaliero-Universitaria S. Giovanni Battista (Le Molinette)
Torino, Italy
1311 - Azienda Ospedaliera di Verona
Verona, Italy
Netherlands
2204 - UMC Groningen
Groningen, Netherlands
2201 - Daniel Den Hoed Hospitaal
Rotterdam, Netherlands
Poland
1905 - Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Poland
1907 - Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
1908 - Swietokrzyskie Centrum Onkologii
Kielce, Poland
1902 - Uniwersytet Medyczny w Lublinie
Lublin, Poland
1901 - Klinika Hematologii - Instytut Hematologii i Transfuzjologii
Warsaw, Poland
1906 - MTZ Clinical Research Sp. z o.o.
Warsaw, Poland
1904 - Samodzielny Publiczny
Wrocław, Poland
Romania
2101 - Institutul Clinic Fundeni, Hematologie II
Bucharest, Romania
2102 - Spitalul Clinic Coltea, Hematologie
Bucharest, Romania
2106 - Institutul Oncologic "Prof. Dr. I. Chiricuta"
Cluj-Napoca, Romania
2105 - Institutul Regional de Oncologie
Iasi, Romania
Russian Federation
2001 - Russian Hematology Research Center
Moscow, Russian Federation
2003 - Municipal Hospital No. 15
St. Petersburg, Russian Federation
Spain
1401 - ICO Hospital Germans Trias I Pujol
Badalona, Spain
1404 - Hospital Clínic Servei d´Hematologia
Barcelona, Spain
1402 - Complexo Hospitalario Universitario A Coruña
La Coruña, Spain
1408 - Hospital 12 de Octubre
Madrid, Spain
1405 - Hospital Universitari Son Espases
Mallorca, Spain
1407 - Unidad de Citogenética Oncológica
Salamanca, Spain
1406 - Hospital Universitari i Politècnic La Fe de Valencia
Valencia, Spain
United Kingdom
1605 - Queen Elizabeth Hospital
Birmingham, United Kingdom
1602 - Bristol Royal Infirmary
Bristol, United Kingdom
1604 - University Hospital of Wales
Cardiff, United Kingdom
1601 - Royal Free Hospital
London, United Kingdom
1607 - Nottingham City Hospital NHS Trust
Nottingham, United Kingdom
Sponsors and Collaborators
Amgen Research (Munich) GmbH
Investigators
Principal Investigator: Ralf Bargou, MD Medizinische Klinik und Poliklinik II, Würzburg
Principal Investigator: Nicola Gökbuget, MD Klinikum der Goethe Universität Frankfurt
  More Information

No publications provided

Responsible Party: Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier: NCT01207388     History of Changes
Other Study ID Numbers: MT103-203
Study First Received: September 21, 2010
Last Updated: January 22, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Amgen Research (Munich) GmbH:
Blinatumomab
MRD
B-ALL
Minimal residual disease
adult ALL
Leukemia
ALL
Lymphatic diseases
Lymphoproliferative disorders
bispecific antibody
anti-CD19
Immunotherapeutic treatment

Additional relevant MeSH terms:
Burkitt Lymphoma
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasm, Residual
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014