Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor ALL (BLAST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier:
NCT01207388
First received: September 21, 2010
Last updated: January 22, 2014
Last verified: January 2014
  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:
  • AMG103
  • MT103

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207388

  Show 75 Study Locations
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: January 22, 2014
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:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Burkitt Lymphoma
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, B-Cell
Neoplasms, Experimental
Neoplastic Processes
Pathologic Processes
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014