|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Micromet AG |
| Information provided by: | Micromet AG |
| 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 |
| MedlinePlus related topics: | Cancer Lymphoma |
| ChemIDplus related topics: | Visilizumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
| 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: | 45 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | May 2009 |
| Arms | Assigned Interventions |
|
1: Experimental
Patients receive Blinatumomab as continuous intravenous infusion over 4-8 weeks
|
Drug: Blinatumomab (MT103)
doses from 5 to 120µg/m2/24h, continuous intravenous (CIV), over 4-8 weeks
|
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 renal or hepatic function as defined below:
Indication of hypercoagulative state as defined below:
Contacts and Locations| Contact: Petra Klappers | +4989895277 ext 321 | petra.klappers@micromet.de |
| Contact: Gerhard Zugmaier, MD | +4989895277 ext 335 | gerhard.zugmaier@micromet.de |
| Germany | |||||
| Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg | Recruiting | ||||
| Würzburg, Germany, 97080 | |||||
| Contact: Ralf Bargou, MD, PhD +4993120170000 bargou_r@medizin.uni-wuerzburg.de | |||||
| Principal Investigator: Ralf Bargou, MD, PhD | |||||
| Robert Rössle Klinik Campus Berlin Buch, Hämatologie Onkologie | Recruiting | ||||
| Berlin, Germany, 13125 | |||||
| Contact: Martin Hildebrand, MD, PhD +493094170 mhildebrandt@helios-kliniken.de | |||||
| Principal Investigator: Martin Hildebrandt, MD, PhD | |||||
| Universitätsklinikum Essen, Klinik für Hämatologie, Medizinische Klinik und Poliklinik | Recruiting | ||||
| Essen, Germany, 45147 | |||||
| Contact: Richard Noppeney, MD, PhD +492017233645 richard.noppeney@uni-essen.de | |||||
| Principal Investigator: Richard Noppeney, MD, PhD | |||||
| Klinikum der Johannes-Gutenberg Universität | Recruiting | ||||
| Mainz, Germany, 55131 | |||||
| Contact: Georg Hess, MD, PhD +496131175735 g.hess@3-med.klinik.uni-mainz.de | |||||
| Principal Investigator: Georg Hess, MD, PhD | |||||
| Universitätsklinikum Ulm, Abteilung Innere Medizin III | Recruiting | ||||
| Ulm, Germany, 89081 | |||||
| Contact: Andreas Viardot, MD, PhD +4973150045539 andreas.viardot@medizin.uni-ulm.de | |||||
| Principal Investigator: Andreas Viardot, MD, PhD | |||||
| Micromet AG |
| Principal Investigator: | Ralf Bargou, MD, PhD | Medizinische Poliklinik der Julius-Maximilians-Universität Würzburg, Klinikstrasse 6-8, D-97080 Würzburg |
More Information
| Responsible Party: | Micromet AG, Clinical Development ( Gerhard Zugmaier, MD ) |
| Study ID Numbers: | MT103-104 |
| First Received: | January 10, 2006 |
| Last Updated: | August 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00274742 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
|
|
|
|
|