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Sponsored by: |
Micromet AG |
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Information provided by: | Micromet AG |
ClinicalTrials.gov Identifier: | NCT00560794 |
The purpose of this study is to determine whether the bispecific T-cell engager (BiTE®) Blinatumomab (MT103) is effective in the treatment of ALL patients with minimal residual disease.
Condition | Intervention | Phase |
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Acute Lymphoblastic Leukemia |
Drug: Blinatumomab (MT103) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Open-label, Multicenter Phase II Study to Investigate the Efficacy, Safety, and Tolerability of the Bispecific T-cell Engager (BiTE®) MT103 in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia |
Estimated Enrollment: | 21 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | February 2010 |
Arms | Assigned Interventions |
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1: Experimental
Patients will receive Blinatumomab (MT103) as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 weeks treatment free period, defined as one treatment cycle (up to a maximum of 10 cycles)
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Drug: Blinatumomab (MT103)
15µg/m2/24h,30µg/m2/24h, or 60µg/m2/24h continuous intravenous (CIV) over 4 weeks, up to 10 cycles or progression or unacceptable toxicity
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The presence of leukemia cells below the cytological detection limit (5% leukemic cells) is defined as minimal residual disease (MRD). If no MRD is detectable (<10-4 =< 1 leukemia cell per 104 bone marrow cells) a complete molecular remission is reached. In the last years a series of retrospective studies has shown that MRD in adult ALL is an independent prognostic factor as already demonstrated for childhood leukemia. Diagnostic tools for MRD are polymerase chain reaction (PCR) and/or flow cytometry. PCR analysis can detect fusion transcripts such as bcr/abl and individual clonal rearrangements of immu-noglobulins (IgH) and/or T-cell receptor genes (TCR). About 25% of patients with MRD defined by rearrangement comprise a high-risk group with a 94% relapse rate within 3 years. In general for patients with MRD, who are not eligible for allogenic stem cell transplantation, curative treatment is not available. This accounts for MRD defined by the Philadelphia chromosome translocation as well as for MRD defined by rearrangement. The current study is set up to address the question of treating MRD positive ALL with the bispecific anti-CD19 x anti-CD3 antibody derivative Blinatumomab (MT103).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ralf Bargou, Professor | +49 931 202-0 ext 70150 | bargou_r@klinik.uni-wuerzburg.de |
Contact: Max Topp, MD | +49 931 202-0 ext 70490 | topp_m@klinik.uni-wuerzburg.de |
Germany, Baden-Württemberg | |
Universitätsklinikum Ulm | Recruiting |
Ulm, Baden-Württemberg, Germany, 89081 | |
Contact: Andreas Viardot, MD +49 731 500-0 ext 45501 andreas.viardot@uniklinik-ulm.de | |
Contact: Mathias Schmid, MD +49 731 500-0 ext 45501 mathias.schmid@uniklinik-ulm.de | |
Principal Investigator: Andreas Viardot, MD | |
Germany, Bayern | |
Julius-Maximilians-Universität Würzburg | Recruiting |
Würzburg, Bayern, Germany, 97080 | |
Contact: Ralf Bargou, Professor +49 931 201-0 ext 70800 bargou_r@klinik.uni-wuerzburg.de | |
Contact: Max Topp, MD +49 931 201-0 ext 70490 topp_m@klinik.uni-wuerzburg.de | |
Principal Investigator: Ralf Bargou, Professor | |
Germany, Hessen | |
Klinikum der J.W. Goethe Universität | Recruiting |
Frankfurt, Hessen, Germany, 60590 | |
Contact: Nicola Gökbuget, MD +49 69 6301-0 ext 6365 goekbuget@em.uni-frankfurt.de | |
Contact: Oliver Ottmann, MD +49 69 6301-0 ext 6365 ottmann@em.uni-frankfurt.de | |
Principal Investigator: Nicola Gökbuget, MD | |
Germany, Nordrhein-Westfalen | |
Universitätsklinikum Essen | Recruiting |
Essen, Nordrhein-Westfalen, Germany, 45147 | |
Contact: Richard Noppeney, MD +49 201 723-0 ext 3645 richard.noppeney@uk-essen.de | |
Contact: Christine Kuhnert +49 201 723-0 ext 2553 chrisitine.kuhnert@uk-essen.de | |
Principal Investigator: Richard Noppeney, MD | |
Universitätsklinikum Münster | Recruiting |
Münster, Nordrhein-Westfalen, Germany, 48129 | |
Contact: Matthias Stelljes, MD +49 251 83-0 ext 52801 stelljes@uni-muenster.de | |
Contact: Christian Pohlkamp, MD +49 251 83-0 ext 52801 christian.pohlkamp@hotmail.de | |
Principal Investigator: Matthias Stelljes, MD | |
Germany, Sachsen | |
Universitätsklinikum Carl Gustav Carus | Recruiting |
Dresden, Sachsen, Germany, ´01307 | |
Contact: Ralph Naumann, MD +49 351 458-0 ext 3855 ralph.naumann@uniklinikum-dresden.de | |
Contact: Thomas Illmer, MD +49 351 458-0 ext 2046 thomas.illmer@uniklinikum-dresden.de | |
Principal Investigator: Ralph Naumann, MD | |
Germany, Schleswig-Holstein | |
Universitätsklinikum Schleswig-Holstein im Städtischen Krankenhaus Kiel | Recruiting |
Kiel, Schleswig-Holstein, Germany, 24116 | |
Contact: Heinz-A. Horst, Professor +49 431 1697-0 ext 1207 h.horst@med2.uni-kiel | |
Contact: Svenja Neumann, MD +49 431 1697-0 ext 5215 | |
Principal Investigator: Heinz-A. Horst, Professor |
Principal Investigator: | Ralf Bargou, Professor | Julius-Maximilians-Universität Würzburg |
Responsible Party: | Micromet AG, Clinical Development ( Gerhard Zugmaier, MD ) |
Study ID Numbers: | MT103-202 |
Study First Received: | November 19, 2007 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00560794 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Minimal Residual Disease adult ALL immunotherapeutic treatment |
anti-CD19 bispecific antibody derivative Blinatumomab MT103 |
Neoplasm, Residual Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antibodies, Bispecific Leukemia Lymphatic Diseases |
Antibodies Bites and Stings Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia Immunoglobulins |
Neoplasm, Residual Lymphatic Diseases Leukemia Neoplastic Processes Neoplasms Leukemia, Lymphoid |
Pathologic Processes Immunoproliferative Disorders Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Lymphoproliferative Disorders |