Long-term Follow-up of Adult Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia Relapsed Refractory Patients Enrolled in Study 00103311 (TOWER Follow-up Study)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  One-time follow-up on patients that were alive and still participating in the Phase III Study 00103311 at the end of the 00103311 study results being reported.

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BLINATUMOMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX07) blinatumomab

  blinatumomab
• Medical condition to be studied:
  Acute lymphocytic leukaemia

Population studied

• Short description of the study population:
  The population in this study will be the patients who were enrolled originally in the 00103311 trial (A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)). This study (20180138) will be a one-time follow-up on patients that were alive and still participating in the Phase III Study 00103311 at the end of the 00103311 study results being reported.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Acute lymphocytic leukaemia patients
• Estimated number of subjects:
  108

Study design details

• Main study objective:
  The objective of this study is to update the overall survival (OS) Kaplan-Meier probability estimates and the plot last reported in the randomized Phase 3 blinatumomab 00103311 study.
• Outcomes:
  Overall survival
• Data analysis plan:
  The endpoint in this study is overall survival. Overall survival is defined as time from randomization of blinatumomab or investigator choice chemotherapy (the two treatment arms in the 00103311 trial) until the event of death or censoring at end of follow-up.For the analysis, overall survival Kaplan-Meier probabilities and plot last reported in the 00103311 study will be updated to provide a final table of survival probabilities at defined time points (3 months, 6 months, 12 months, 18 months, 24 months, 36 months) with relevant 95% confidence intervals and a final plot.A sensitivity analysis will be conducted assessing whether patients in thestandard of care arm who had blinatumomab use during the 00103311 trial and after the study's termination had an effect on the survival outcomes of this group.