Status:
COMPLETED
Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Amgen Research (Munich) GmbH
Conditions:
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 antibody blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory Acute Lymphob...
Detailed Description
Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease with dismal prognosis. Several studies have reported long term survival to be below 10%. Major prognostic facto...
Eligibility Criteria
Inclusion
- Patients with Philadelphia chromosome (Ph)-negative B-precursor ALL, with any of the following:
- relapsed or refractory with first remission duration less than or equal to 12 months in first salvage or
- relapsed or refractory after first salvage therapy or
- relapsed or refractory within 12 months of allogeneic hematopoietic stem cell transplantation (HSCT)
- 10% or more blasts in bone marrow
- In case of clinical signs of additional extramedullary disease: measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Age ≥ 18 years
Exclusion
- Patients with Ph-positive ALL
- Patients with Burkitt's Leukemia according to World Health organization (WHO) classification
- History or presence of clinically relevant central nervous system (CNS) pathology
- Active ALL in the CNS or testes
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- Autologous HSCT within six weeks prior to start of blinatumomab treatment
- Allogeneic HSCT within three months prior to start of blinatumomab treatment
- Any active acute graft versus-host disease (GvHD), or active chronic GvHD Grade 2 - 4
- Any systemic therapy against GvHD within two weeks prior to start of blinatumomab treatment
- Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
- Radiotherapy within two weeks prior to start of blinatumomab treatment
- Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treat-ment
- Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
- Treatment with any other investigational medicinal product (IMP) after signature of informed consent
- Eligibility for allogeneic HSCT at the time of enrollment
- Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation
- Abnormal laboratory values indicative of inadequate renal or liver function
- History of malignancy requiring treatment other than ALL within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
- Any concurrent disease or medical condition that is deemed to interfere with the conduct of the study
- Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus
- Pregnant or nursing women
- Women of childbearing potential not willing to use an effective form of contraception. Male patients not willing to ensure not to beget a child
- Previous treatment with blinatumomab
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01466179
Start Date
December 1 2011
End Date
January 1 2017
Last Update
August 18 2017
Active Locations (39)
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1
City of Hope
Duarte, California, United States, 91010-3000
2
University of California Los Angeles
Los Angeles, California, United States, 90095-1678
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
4
Rush University Medical Center
Chicago, Illinois, United States, 60612