Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier:
NCT01209286
First received: September 23, 2010
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of patients with relapsed/refractory B-precursor ALL.


Condition Intervention Phase
B-ALL
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: An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:


Further study details as provided by Amgen Research (Munich) GmbH:

Primary Outcome Measures:
  • Percentage of patients with Complete Remission (CR/CRh*) [ Time Frame: within 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with Minimal Residual Disease (MRD) response [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
  • Time to hematological relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number and severity of adverse events [ Time Frame: within 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: September 2010
Estimated Study Completion Date: December 2016
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blinatumomab Drug: Blinatumomab
15µg/m2/day blinatumomab c.i.v.
Other Names:
  • AMG103
  • MT103
Drug: Blinatumomab
30µg/m2/day blinatumomab c.i.v.
Other Names:
  • AMG103
  • MT103

Detailed Description:

Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease with dismal prognosis and unmet medical need. Additional therapeutic approaches are urgently needed. Blinatumomab 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 investigate the efficacy, safety and tolerability of two doses of the bispecific T-cell engager blinatumomab (MT103) in adult patients with relapsed/refractory B-precursor ALL. Patients will receive up to five 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 relapsed after at least induction and consolidation or having refractory disease
  • More than 5% blasts in bone marrow
  • ECOG performance status ≤ 2
  • Life expectancy of ≥ 12 weeks

Exclusion Criteria:

  • History or presence of clinically relevant CNS pathology
  • Infiltration of cerebrospinal fluid (CSF) by ALL
  • Autologous/allogeneic HSCT within six weeks/three months prior to start of blinatumomab treatment
  • Active Graft-versus-Host Disease (GvHD)
  • Patients with Ph+ ALL eligible for treatment with dasatinib or imatinib
  • Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
  • Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab treatment
  • Infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
  • Pregnant or nursing women
  • 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: NCT01209286

Locations
Germany
Frankfurt, Germany
Freiburg, Germany
Hannover, Germany
Kiel, Germany
Münster, Germany
Regensburg, Germany
Tübingen, Germany
Ulm, Germany
Würzburg, Germany
Sponsors and Collaborators
Amgen Research (Munich) GmbH
Investigators
Principal Investigator: Max Topp, MD Universität Würzburg
  More Information

No publications provided

Responsible Party: Amgen Research (Munich) GmbH
ClinicalTrials.gov Identifier: NCT01209286     History of Changes
Other Study ID Numbers: MT103-206
Study First Received: September 23, 2010
Last Updated: January 22, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Amgen Research (Munich) GmbH:
Blinatumomab
B-ALL
adult ALL
relapsed ALL
refractory 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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014