A Non-Interventional Post-Authorisation Safety Study (PASS) of Inotuzumab Ozogamicin to Characterize Complications Post-Hematopoietic Stem Cell Transplantation (HSCT) Following Inotuzumab Ozogamicin Treatment in Adult and Pediatric Patients with B-Cell Precursor Acute Lymphoblastic Leukemia (ALL).

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-authorisation safety study

Study drug and medical condition

• Medical condition to be studied:
  B-cell type acute leukaemia

Population studied

• Short description of the study population:
  The study population focused on all adult and pediatric US patients with B-cell precursor acute lymphoblastic leukemia (ALL) treated with inotuzumab ozogamicin post-hematopoietic stem cell transplantation (HSCT) identified from the CIBMTR database between 18 August 2017 to 17 August 2022.; Inclusion Criteria:; 1. A record of B-cell precursor ALL diagnosis for adult and pediatric patients receiving dispensation/prescription of inotuzumab ozogamicin prior to or at the; time of the dispensation/prescription.; 2. At least 1 dose of inotuzumab ozogamicin prior to proceeding to HSCT.; 3. Received HSCT from a US transplant center.; ; Exclusion Criteria:; Only data from patients who have consented will be used in this study.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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 lymphoblastic leukemia patients
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  Based on collected data obtained from CIBMTR registry, the following will be evaluated in adult and pediatric patients with B-cell ALL who received inotuzumab ozogamicin and proceeded to HSCT: • Patient-, disease- and HSCT-related characteristics, including details of all prior anti-cancer therapies, • Timing of inotuzumab ozogamicin treatment prior to HSCT, • Transplant-related mortality
• Outcomes:
  1. Patient-, disease- and HSCT-related characteristics, including details of all prior therapies, 2. Timing of inotuzumab ozogamicin treatment in relation to HSCT, 3. Transplant-related mortality (non-relapse mortality), non-transplant related mortality, relapse, and OS in the first 180 days, 4. Post-HSCT adverse events of interest, including VOD/SOS in the first 100 days, 5. COD.
• Data analysis plan:
  There will be no hypothesis testing in this study. All statistical analyses performed will be descriptive. For any p-value reported, there will be no adjustment for multiplicity and no definite conclusion should be made based on the p-value.

Documents

Study results

B1931028 Inotuzumab Final Study Report ABSTRACT 18FEB2023

Study report

B1931028 Inotuzumab Final Study Report 18Feb2023

B1931028 Inotuzumab Interim Report 2_20 Feb 2020 V1_Final

B1931028 Inotuzumab Interim Report 3 Final 17Feb2021

B1931028_INOTUZUMAB INTERIM REPORT 4 FINAL_18 FEB 2022

InO_Study B1931028_Interim report 1_FINAL

Study, other information

B1931028 Inotuzumab Interim Report 2_20 Feb 2020 V1_Final.pdf

B1931028 Inotuzumab Interim Report 3 Final 17Feb2021.pdf

B1931028_INOTUZUMAB INTERIM REPORT 4 FINAL_18 FEB 2022.pdf

InO_Study B1931028_Interim report 1_FINAL.pdf