Status:
COMPLETED
Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Amgen Research (Munich) GmbH
Conditions:
B-ALL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab is effective, safe and tolerable in the treatment of patients with relapsed/refractory B-precursor ALL.
Detailed Description
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. Blinatumom...
Eligibility Criteria
Inclusion
- Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
- More than 5% blasts in bone marrow
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Life expectancy of ≥ 12 weeks
Exclusion
- History or presence of clinically relevant central nervous system (CNS) pathology
- Infiltration of cerebrospinal fluid (CSF) by ALL
- Autologous/allogeneic hematopoietic stem cell transplantation (HSCT) within six weeks/three months prior to start of blinatumomab treatment
- Active Graft-versus-Host Disease (GvHD)
- Patients with Philadelphia chromosome (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 human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
- Pregnant or nursing women
- Previous treatment with blinatumomab
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01209286
Start Date
October 1 2010
End Date
October 1 2016
Last Update
March 6 2017
Active Locations (9)
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1
Frankfurt, Germany
2
Freiburg im Breisgau, Germany
3
Hanover, Germany
4
Kiel, Germany