Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute L… (NCT02013167) | Clinical Trial Compass
TerminatedPhase 3
Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)
United States405 participantsStarted 2014-01-03
Plain-language summary
The primary objective was to evaluate the effect of blinatumomab on overall survival when compared to standard of care (SOC) chemotherapy.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 blinatumom…
What they're measuring
1
Overall Survival
Timeframe: From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group.