Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005163

Trial Description

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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)

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Trial Acronym

BLAST

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00005163
  •   2013/10/21
  •   2010/09/21
  •   no
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Secondary IDs

  •   NCT01207388  (ClinicalTrials.gov)
  •   MT103-203  (Amgen Research (Munich) GmbH)
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Health Condition or Problem studied

  •   B-cell Acute Lymphoblastic Leukemia
  •   C91.0 -  Acute lymphoblastic leukaemia
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Interventions/Observational Groups

  •   Drug: Blinatumomab
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

- MRD response rate; time frame: within 6 weeks

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Secondary Outcome

- Hematological relapse-free survival rate; time frame: 18 months
- Overall survival; time frame: 5 years
- Duration of complete MRD response; time frame: 2 years
- Overall incidence and severity of AEs; time frame: until EoS
- Quality of Life; time frame: until EoS

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Countries of Recruitment

  •   Austria
  •   Belgium
  •   France
  •   Germany
  •   Italy
  •   Netherlands
  •   Poland
  •   Romania
  •   Russian Federation
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2010/09/30
  •   130
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Amgen Research (Munich) GmbH
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    •   [---]*
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    • Medizinische Klinik und Poliklinik II, Würzburg
    • Ralf Bargou, MD 
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    •   [---]*
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    • Dirk Nagorsen, MD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.