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

September 21, 2010
January 22, 2014
September 2010
February 2014   (final data collection date for primary outcome measure)
MRD response rate [ Time Frame: within 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01207388 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor ALL
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)

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
B-cell Acute Lymphoblastic Leukemia
Drug: Blinatumomab
intravenous infusion
Other Names:
  • AMG103
  • MT103
Experimental: Blinatumomab
single arm
Intervention: Drug: Blinatumomab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
August 2016
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Poland,   Romania,   Russian Federation,   Spain,   United Kingdom
 
NCT01207388
MT103-203
Yes
Amgen Research (Munich) GmbH
Amgen Research (Munich) GmbH
Not Provided
Principal Investigator: Ralf Bargou, MD Medizinische Klinik und Poliklinik II, Würzburg
Principal Investigator: Nicola Gökbuget, MD Klinikum der Goethe Universität Frankfurt
Amgen Research (Munich) GmbH
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP