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

• Status: Terminated
• Trial end date: 2017-03-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Bispecific; Antineoplastic Agents; Blinatumomab

Criteria

• Subjects with Philadelphia negative B-precursor ALL, with any of the following:

• refractory to primary induction therapy or refractory to salvage therapy,

• in untreated first relapse with first remission duration <12 months

• in untreated second or greater relapse

• relapse at any time after allogeneic HSCT

• Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.

• Greater than 5% blasts in the bone marrow

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria

• 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.