An observational study describing the effectiveness and safety of BLINCYTO® in Chinese adults with Philadelphia chromosome-positive relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (Ph+ R/R B-cell precursor ALL) (20210061)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other

Study drug and medical condition

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

  blinatumomab
• Additional medical condition(s):
  Philadelphia chromosome-positive relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (Ph+ R/R B-cell precursor ALL)

Population studied

• 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)
• Estimated number of subjects:
  30

Study design details

• Main study objective:
  The main objective of the study is to estimate the percentage of patients with complete remission/complete remission with partial hematological recovery (CR/CRh) within two cycles of treatment with BLINCYTO® in Chinese adults with Ph+ R/R B-cell precursor ALL, and to estimate the incidence of adverse events of interest (EOI).
• Outcomes:
  - To estimate the percentage of patients with CR/CRh within two cycles of treatment with BLINCYTO in Chinese adults with Ph+ R/R B-cell precursor ALL To estimate the incidence of adverse EOI (recorded within 6 months of first infusion of BLINCYTO), ; - To describe the treatment patterns of BLINCYTO and tyrosine kinase inhibitors in clinical practice ; - To estimate the occurrence of allogeneic haemopoietic stem cell transplant after BLINCYTO treatment ; - To estimate the percentage of patients achieving minimal residual disease negative status after CR/CRh ; - To estimate relapse-free survival at 6 months To estimate overall survival at 6 months
• Data analysis plan:
  Analyses will be descriptive in nature. Demographic and patient characteristics will be summarized by descriptive statistics. ; Continuous variables will be summarized by n, mean, standard deviation, median, Q1 (25th percentile), Q3 (75th percentile), and ranges. Categorical variables will be summarized by counts and percentages for each category. Proportion and 95% CIs will be reported for patients with CR/CRh, MRD negative status, and alloHSCT. ; For time-to-event outcomes, the Kaplan-Meier (K-M) method will be used to estimate the 6-month OS probability, including survival rates at selected timepoints (eg, 3-or 6-month, 12-month).

Documents

Study results

20210061_ORSR_abstract_Redacted (1).pdf