Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (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 28, 2015
Last verified: January 2014

September 21, 2010
January 28, 2015
November 2010
February 2014   (final data collection date for primary outcome measure)
Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle [ Time Frame: During the first cycle (6 weeks) ] [ Designated as safety issue: No ]

At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory.

Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle.

MRD response rate [ Time Frame: within 6 weeks ] [ Designated as safety issue: No ]
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 ]
  • 100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant [ Time Frame: 100 days after HSCT ] [ Designated as safety issue: No ]
  • Time to Hematological Relapse [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Duration of Complete MRD Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • MRD Level [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events [ Time Frame: Adverse events are reported until the data cut-off date of 21 February 2014; the median treatment duration was 52 days. ] [ Designated as safety issue: Yes ]

    Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.

    The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.

    An AE was considered "serious" if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition.

  • Quality of Life [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Resource Utilization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (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.

Participants will receive up to four 4-week cycles of intravenous blinatumomab treatment followed by an infusion-free period of 14 days. A safety follow-up will be performed 30 days after the end of the last infusion and efficacy follow-ups will occurr until 24 months after treatment start. Participants will be followed for up to 5 years after the start of treatment for survival.

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
Continuous intravenous infusion
Other Names:
  • AMG103
  • MT103
  • BLINCYTO™
Experimental: Blinatumomab
Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
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
116
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 human immunodeficiency virus (HIV) test, negative hepatitis B (HbsAg) test and hepatitis C virus (anti-HCV) test
  • Negative pregnancy test in women of childbearing potential
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

  • Presence of circulating blasts or current extra-medullary involvement by ALL
  • History of relevant central nervous system (CNS) pathology or current CNS pathology
  • Prior allogeneic hematopoietic stem cell transplant (HSCT)
  • Eligibility for treatment with tyrosine-kinase inhibitors (TKI)
  • 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