Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor ALL (BLAST)
This study is currently recruiting participants.
Verified November 2012 by Amgen Research (Munich) GmbH
Sponsor:
Amgen Research (Munich) GmbH
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier:
NCT01207388
First received: September 21, 2010
Last updated: November 20, 2012
Last verified: November 2012
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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:
|
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
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Contacts
| Contact: Dirk Nagorsen, MD | +49-89-895277 ext 337 | dirkn@amgen.com |
| Contact: Julia Stieglmaier, PhD | +49-89-895277 ext 359 | jstieglm@amgen.com |
Hide Study LocationsLocations
| Austria | |
| 1102 - LKH Graz | Recruiting |
| Graz, Austria | |
| Principal Investigator: Werner Linkesch, Prof. Dr. | |
| 1107 - Krankenhaus der Elisabethinen | Recruiting |
| Linz, Austria | |
| Principal Investigator: Hedwig Kasparu, Dr. | |
| 1106 | Recruiting |
| Salzburg, Austria | |
| Principal Investigator: Richard Greil, Prof. Dr. | |
| 1101 - AKH Wien | Recruiting |
| Vienna, Austria | |
| Principal Investigator: Ulrich Jäger, Prof. Dr. | |
| Sub-Investigator: Alexander Hauswirth, PD Dr. | |
| Belgium | |
| 1504 | Recruiting |
| Antwerpen, Belgium | |
| Principal Investigator: Pierre Zachee, Prof. Dr. | |
| 1502 - Cliniques Universitaires de Saint-Luc | Recruiting |
| Brussels, Belgium | |
| Principal Investigator: Violaine Havelange, Dr. | |
| 1505 | Recruiting |
| Brügge, Belgium | |
| Principal Investigator: Dominik L Selleslag, Dr. | |
| 1503 | Recruiting |
| Gent, Belgium | |
| Principal Investigator: Lucien Noens, Prof. Dr. | |
| 1501 - Cliniques Universitaires UCL de Mont Godinne | Recruiting |
| Yvoir, Belgium | |
| Principal Investigator: Carlos Graux, Prof. Dr. | |
| France | |
| 1211 - CHU d'Angers | Recruiting |
| Angers, France | |
| Principal Investigator: Mathilde Hunault, Dr. | |
| 1210 - CHU de Besançon | Recruiting |
| Besançon, France | |
| Principal Investigator: Pierre S Rohrlich, Prof. Dr. | |
| 1206 - Hôpital de Pontoise | Recruiting |
| Cergy Pontoise, France | |
| Contact: Riad Benramdane, Dr. | |
| Principal Investigator: Riad Benramdane, MD | |
| 1205 - CHU Henri Mondor | Recruiting |
| Créteil, France | |
| Principal Investigator: Sébastien Maury, Dr. | |
| 1209 - CHU de Lyon | Recruiting |
| Lyon, France | |
| Principal Investigator: Xavier Thomas, Prof. Dr. | |
| 1212 - Hôpital de l'hôtel Dieu | Recruiting |
| Nantes, France | |
| Principal Investigator: Patrice Chevallier, Dr. | |
| 1213 - Centre Hospitalier Universitaire de Nice | Recruiting |
| Nice, France | |
| Principal Investigator: Faézeh Legrand, Dr. | |
| 1201 - Hôpital Saint Louis | Recruiting |
| Paris, France | |
| Contact: Hervé Dombret, Prof. Dr. | |
| Principal Investigator: Hervé Dombret, Prof. Dr. | |
| 1202 - CHU de Bordeaux - Hôpital Haut Lévêque | Recruiting |
| Pessac, France | |
| Principal Investigator: Thibaut Leguay, Dr. | |
| 1208 - CHU de Purpan | Recruiting |
| Toulouse, France | |
| Principal Investigator: Françoise Rigal-Huguet, Dr. | |
| Germany | |
| 1011 - Charité Berlin | Recruiting |
| Berlin, Germany | |
| Principal Investigator: Stefan Schwartz, PD Dr. | |
| 1022 - Universitätsklinkum Carl Gustav Carus Dresden | Recruiting |
| Dresden, Germany | |
| Principal Investigator: Gerhard Ehninger, Prof. Dr. | |
| 1009 - Universitätsklinikum Essen | Recruiting |
| Essen, Germany | |
| Principal Investigator: Andreas Hüttmann, PD Dr. | |
| 1002 - Klinikum der Goethe Universität | Recruiting |
| Frankfurt, Germany | |
| Principal Investigator: Nicola Gökbuget, Dr. | |
| 1014 - Asklepiosklinik St. Georg | Recruiting |
| Hamburg, Germany | |
| Principal Investigator: Norbert Schmitz, Prof. Dr. | |
| 1018 - Medizinische Hochschule Hannover | Recruiting |
| Hannover, Germany | |
| Principal Investigator: Arnold Ganser, Prof. Dr. | |
| 1012 - Universitätsklinikum Heidelberg | Recruiting |
| Heidelberg, Germany | |
| Principal Investigator: Eike Buss, Dr. | |
| 1003 - Universitätsklinikum Schleswig-Holstein | Recruiting |
| Kiel, Germany | |
| Principal Investigator: Svenja Neumann, Dr. | |
| 1019 - Universitätsklinikum Leipzig | Recruiting |
| Leipzig, Germany | |
| Principal Investigator: Dietger Niederwieser, Prof. Dr. | |
| 1010 - Klinikum der Universität München - Großhadern | Recruiting |
| Munich, Germany | |
| Principal Investigator: Marion Subklewe, PD Dr. | |
| 1004 - Universitätsklinikum Münster | Recruiting |
| Münster, Germany | |
| Principal Investigator: Matthias Stelljes, Prof. Dr. | |
| 1016 - Universitätsklinikum Regensburg | Recruiting |
| Regensburg, Germany | |
| Principal Investigator: Albrecht Reichle, Prof. Dr. | |
| 1020 - Universitätsklinikum Rostock | Recruiting |
| Rostock, Germany | |
| Principal Investigator: Christian Junghanß, Prof. Dr. | |
| 1007 - Robert-Bosch-Krankenhaus | Recruiting |
| Stuttgart, Germany | |
| Principal Investigator: Walter-Erich Aulitzky, Prof. Dr. | |
| 1015 - Universitätsklinikum Tübingen | Recruiting |
| Tübingen, Germany | |
| Principal Investigator: Christoph Faul, Dr. | |
| 1005 - Universitätsklinikum Ulm | Recruiting |
| Ulm, Germany | |
| Contact: Andreas Viardot, Dr. | |
| Principal Investigator: Andreas Viardot, Dr. | |
| 1001 - Julius-Maximilians-Universität Würzburg | Recruiting |
| Würzburg, Germany | |
| Contact: Ralf C Bargou, Prof. Dr. | |
| Principal Investigator: Ralf C Bargou, Prof. Dr. | |
| Italy | |
| 1301 - Ospedali Riuniti di Bergamo | Recruiting |
| Bergamo, Italy | |
| Principal Investigator: Alessandro Rambaldi, Prof. Dr. | |
| 1303 - Istituto di Ematologia "L.& A.Seràgnoli" Azienda | Recruiting |
| Bologna, Italy | |
| Principal Investigator: Giovanni Martinelli, Dr. | |
| 1314 - Azienda Ospedaliera Spedali Civili Brescia | Recruiting |
| Brescia, Italy | |
| Principal Investigator: Guiseppe Rossi, Dr. | |
| 1313 - Universita di Catania | Recruiting |
| Catania, Italy | |
| Principal Investigator: Francesco Di Raimondo, Prof. Dr. | |
| 1312 - Azienda Ospedaliera Universitaria San Martino | Recruiting |
| Genoa, Italy | |
| Principal Investigator: Angelomichele Carella, Dr. | |
| 1305 - Ospedale San Gerardo | Recruiting |
| Monza, Italy | |
| Principal Investigator: Enrico M Pogliani, Prof. Dr. | |
| 1309 - Azienda Ospedaliera Antonio Cardarelli | Recruiting |
| Napoli, Italy | |
| Principal Investigator: Felicetto Ferrara, Dr. | |
| 1308 - Ospedali Riuniti "Villa Sofia-Cervello" | Recruiting |
| Palermo, Italy | |
| Principal Investigator: Franceso Fabbiano, Dr. | |
| 1302 - Università La Sapienza di Roma | Recruiting |
| Rome, Italy | |
| Principal Investigator: Robin Foà, Prof. Dr. | |
| 1310 - Fondazione Policlinico Tor Vergata | Recruiting |
| Rome, Italy | |
| Principal Investigator: Sergio Amadori, Prof. Dr. | |
| 1315 - Azienda Ospedaliero-Universitaria S. Giovanni Battista (Le Molinette) | Recruiting |
| Torino, Italy | |
| Principal Investigator: Fillippo Marmont, Dr. | |
| 1311 - Azienda Ospedaliera di Verona | Recruiting |
| Verona, Italy | |
| Principal Investigator: Giovanni Pizzolo, Prof. Dr. | |
| Netherlands | |
| 2204 - UMC Groningen | Recruiting |
| Groningen, Netherlands | |
| Principal Investigator: Simon Daenen, Dr. | |
| 2201 - Daniel Den Hoed Hospitaal | Recruiting |
| Rotterdam, Netherlands | |
| Principal Investigator: Jan Cornelissen, Prof. Dr. | |
| Poland | |
| 1905 - Uniwersytecki Szpital Kliniczny w Białymstoku | Recruiting |
| Bialystok, Poland | |
| Principal Investigator: Janusz Kłoczko, Prof. Dr. | |
| 1907 - Uniwersyteckie Centrum Kliniczne | Recruiting |
| Gdansk, Poland | |
| Principal Investigator: Andrzej Hellmann, Prof. Dr. | |
| 1908 - Swietokrzyskie Centrum Onkologii | Recruiting |
| Kielce, Poland | |
| Principal Investigator: Marcin Pasiarski, Dr. | |
| 1902 - Uniwersytet Medyczny w Lublinie | Recruiting |
| Lublin, Poland | |
| Principal Investigator: Maria Cioch, Dr. | |
| 1901 - Klinika Hematologii - Instytut Hematologii i Transfuzjologii | Recruiting |
| Warsaw, Poland | |
| Principal Investigator: Krzysztof Warzocha, Prof. Dr. | |
| 1906 - MTZ Clinical Research Sp. z o.o. | Recruiting |
| Warsaw, Poland | |
| Principal Investigator: Wiesław Wiktor Jędrzejczak, Prof. Dr. | |
| 1904 - Samodzielny Publiczny | Recruiting |
| Wrocław, Poland | |
| Principal Investigator: Kazimierz Kuliczkowski, Prof. Dr. | |
| Romania | |
| 2101 - Institutul Clinic Fundeni, Hematologie II | Recruiting |
| Bucharest, Romania | |
| Principal Investigator: Daniel Coriu, Prof | |
| 2102 - Spitalul Clinic Coltea, Hematologie | Recruiting |
| Bucharest, Romania | |
| Principal Investigator: Gabriela Borsaru, Dr. | |
| 2106 - Institutul Oncologic "Prof. Dr. I. Chiricuta" | Recruiting |
| Cluj-Napoca, Romania | |
| Principal Investigator: Andrei Mircea Cucuianu, Dr. | |
| 2105 - Institutul Regional de Oncologie | Recruiting |
| Iasi, Romania | |
| Principal Investigator: Catalin Doru Danaila, Dr. | |
| Russian Federation | |
| 2001 - Russian Hematology Research Center | Recruiting |
| Moscow, Russian Federation | |
| Principal Investigator: Elena Parovichnikova, Dr. | |
| 2003 - Municipal Hospital No. 15 | Not yet recruiting |
| St. Petersburg, Russian Federation | |
| Principal Investigator: Elena Karyagina, Dr. | |
| Spain | |
| 1401 - ICO Hospital Germans Trias I Pujol | Recruiting |
| Badalona, Spain | |
| Principal Investigator: Jose-María Ribera, Dr. | |
| 1404 - Hospital Clínic Servei d´Hematologia | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Jordi Esteve, Dr. | |
| 1402 - Complexo Hospitalario Universitario A Coruña | Recruiting |
| La Coruña, Spain | |
| Principal Investigator: Guillermo Deben, Dr. | |
| 1408 - Hospital 12 de Octubre | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Carlos Grande García, Dr. | |
| 1405 - Hospital Universitari Son Espases | Recruiting |
| Mallorca, Spain | |
| Principal Investigator: Juan Besalduch-Vidal, Dr. | |
| 1407 - Unidad de Citogenética Oncológica | Recruiting |
| Salamanca, Spain | |
| Principal Investigator: Jesús María Hernández-Rivas, Dr. | |
| 1406 - Hospital Universitari i Politècnic La Fe de Valencia | Recruiting |
| Valencia, Spain | |
| Principal Investigator: Miguel Ángel Sanz, Dr. | |
| United Kingdom | |
| 1605 - Queen Elizabeth Hospital | Recruiting |
| Birmingham, United Kingdom | |
| Principal Investigator: Sridhar Chaganti, Dr. | |
| 1602 - Bristol Royal Infirmary | Recruiting |
| Bristol, United Kingdom | |
| Principal Investigator: David Marks, Prof. | |
| 1604 - University Hospital of Wales | Recruiting |
| Cardiff, United Kingdom | |
| Principal Investigator: Clare Judith Rowntree, Dr. | |
| 1601 - Royal Free Hospital | Recruiting |
| London, United Kingdom | |
| Principal Investigator: Adele Fielding, Dr. | |
| 1607 - Nottingham City Hospital NHS Trust | Recruiting |
| Nottingham, United Kingdom | |
| Principal Investigator: Andrew McMillan, Dr. | |
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: | November 20, 2012 |
| 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 May 16, 2013