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
Show 75 Study Locations
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 |
Show 75 Study LocationsSponsors 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