Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Stopped early · Phase 3

Conditions studied: Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

In brief

The primary objective was to evaluate the effect of blinatumomab on overall survival when compared to standard of care (SOC) chemotherapy.

Key facts

Study ID: NCT02013167
Run by: Amgen
People needed: 405
Starts: 2014-01-03
Expected to finish: 2017-03-14
Last updated by the study team: 2024-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Malignancy other than ALL within 5 years before blinatumomab treatment, except for adequately treated selected cancers without evidence of disease
Diagnosis of Burkitt's leukemia according to World Health Organization classification, or human immunodeficiency virus (HIV), Hepatitis B or C, or other clinically significant disorder
Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement
Isolated extramedullary disease
Current autoimmune disease or history of autoimmune disease with potential CNS involvement
Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment
Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment
Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert)
Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy
Abnormal laboratory values (alanine or aspartate transaminase [ALT or AST] or alkaline phosphatase [ALP] ≥ 5 × upper limit of normal [ULN]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance < 60 mL/min.

Where it is running

Research Site — Los Angeles, California, United States
Research Site — San Francisco, California, United States
Research Site — Atlanta, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Baltimore, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Boston, Massachusetts, United States
Research Site — Rochester, Minnesota, United States
Research Site — St Louis, Missouri, United States
Research Site — New York, New York, United States
Research Site — Durham, North Carolina, United States
Research Site — Greenville, South Carolina, United States
Research Site — Nashville, Tennessee, United States
Research Site — Houston, Texas, United States
Research Site — Milwaukee, Wisconsin, United States
Research Site — St Leonards, New South Wales, Australia
Research Site — Herston, Queensland, Australia
Research Site — Adelaide, South Australia, Australia
Research Site — Parkville, Victoria, Australia
Research Site — Prahran, Victoria, Australia
Research Site — Murdoch, Western Australia, Australia
Research Site — Salzburg, Austria
Research Site — Vienna, Austria
Research Site — Vienna, Austria
Research Site — Duarte, California, United States

Full record on ClinicalTrials.gov

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