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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
B-ALL

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Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of patients with Complete Remission (CR/CRh*)

Outcome Time Frame:

within 12 weeks

Safety Issue:

No

Principal Investigator

Max Topp, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universität Würzburg

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

MT103-206

NCT ID:

NCT01209286

Start Date:

September 2010

Completion Date:

Related Keywords:

  • B-ALL
  • Blinatumomab
  • B-ALL
  • adult ALL
  • relapsed ALL
  • refractory ALL
  • Leukemia
  • ALL
  • Lymphatic diseases
  • Lymphoproliferative disorders
  • bispecific antibody
  • anti-CD19
  • Immunotherapeutic treatment
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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