Status:
COMPLETED
Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Amgen Research (Munich) GmbH
Conditions:
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 avail...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2019
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01207388
Start Date
November 1 2010
End Date
January 7 2019
Last Update
February 10 2020
Active Locations (75)
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1
1102 - LKH Graz
Graz, Austria
2
1107 - Krankenhaus der Elisabethinen
Linz, Austria
3
1106
Salzburg, Austria
4
1101 - AKH Wien
Vienna, Austria