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| Sponsor: | Micromet GmbH |
|---|---|
| Information provided by: | Micromet GmbH |
| ClinicalTrials.gov Identifier: | NCT00274742 |
Purpose
The purpose of this study is to determine whether a continuous infusion of Blinatumomab (MT103) is safe in the treatment of relapsed Non-Hodgkin's Lymphoma.
Furthermore, the study is intended to provide pharmacokinetic and pharmacodynamic data of Blinatumomab as well as to get first indication of tumour activity.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma, Relapsed |
Drug: Blinatumomab (MT103) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Multi-center Phase I Study to Investigate the Tolerability and Safety of a Continuous Infusion of the Bispecific T-cell Engager MT103 in Patients With Relapsed Non-Hodgkin's Lymphoma (NHL) |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patients receive Blinatumomab as continuous intravenous infusion over 4-8 weeks
|
Drug: Blinatumomab (MT103)
doses from 0.5 to 120µg/m2/24h, continuous intravenous (CIV), over 4-8 weeks
Other Names:
|
Non-Hodgkin's Lymphoma (NHL) represents the 6th most common cancer. Globally, around 165.000 new cases are diagnosed each year, with approx. 90.000 deaths per year. The vast majority of NHLs are B-cell derived (90%) and express common B-cell antigens such as CD19, CD20 and CD22. NHL can be divided into indolent (low-grade) and aggressive (high-grade) lymphomas. Still almost all patients with advanced stage indolent disease will die from their disease. Therefore, a high medical need exists to develop novel agents that further improve the survival of NHL patients.
Blinatumomab (MT103) is a bispecific antibody derivative, anti-CD19 x anti-CD3, designed to link B-cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response against CD19+ cells. Data of prior phase I studies show evidence of biological activity in humans. In vitro and ex-vivo data suggest that a longterm presence of the drug in target tissues may provide antitumour activity.
The study investigates the safety and tolerability of different doses of Blinatumomab administration in a continuous infusion regimen. MTD will be defined in a classical 3+3 dose escalation regimen.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with first or later relapse of histologically (WHO classification) confirmed:
Exclusion Criteria:
Abnormal laboratory values as defined below:
Abnormal renal or hepatic function as defined below:
Indication of hypercoagulative state as defined below:
-antithrombin activity <LLN
Contacts and Locations| Germany | |
| Medizinische Klinik 5, Hämatologie & Internistische Onkologie, Universitätsklinikum Erlangen | |
| Erlangen, Germany, 91054 | |
| Universitätsklinikum Essen, Klinik für Hämatologie, Medizinische Klinik und Poliklinik | |
| Essen, Germany, 45147 | |
| Klinikum der Johannes-Gutenberg Universität | |
| Mainz, Germany, 55131 | |
| Universtätsklinkum Tübingen | |
| Tübingen, Germany, 72076 | |
| Universitätsklinikum Ulm, Abteilung Innere Medizin III | |
| Ulm, Germany, 89081 | |
| Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg | |
| Würzburg, Germany, 97080 | |
| Principal Investigator: | Ralf Bargou, MD, PhD | Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg, Zentrum für Innere Medizin, Oberdürrbacherstr. 6 D-97080 Würzburg |
More Information
| Responsible Party: | Gerhard Zugmaier, MD, Micromet AG, Clinical Development |
| ClinicalTrials.gov Identifier: | NCT00274742 History of Changes |
| Other Study ID Numbers: | MT103-104 |
| Study First Received: | January 10, 2006 |
| Last Updated: | October 5, 2011 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
|
Non-Hodgkin's Lymphoma Cancer immunotherapy Monoclonal antibody anti-CD19 |
anti-CD3 BiTE Blinatumomab |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Antibodies, Bispecific Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |