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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
B-cell Acute Lymphoblastic Leukemia

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Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MRD response rate

Outcome Time Frame:

within 6 weeks

Safety Issue:

No

Principal Investigator

Ralf Bargou, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medizinische Klinik und Poliklinik II, Würzburg

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

MT103-203

NCT ID:

NCT01207388

Start Date:

September 2010

Completion Date:

August 2016

Related Keywords:

  • B-cell Acute Lymphoblastic Leukemia
  • Blinatumomab
  • MRD
  • B-ALL
  • Minimal residual disease
  • adult ALL
  • Leukemia
  • ALL
  • Lymphatic diseases
  • Lymphoproliferative disorders
  • bispecific antibody
  • anti-CD19
  • Immunotherapeutic treatment
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neoplasm, Residual

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