N/A
N=108
Besponsa Post Marketing Surveillance Study
Hematologic Malignancy
Bottom Line
View on ClinicalTrials.gov: NCT04307134 ↗Enrolled (actual)
108
Serious AEs
31.8%
Results posted
Dec 2025
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 99; 34 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Inotuzumab ozogamicin (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
99; 34 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs) |
53; 4 | — |
| PRIMARY Number of Participants With Unexpected AEs and SAEs |
85; 24 | — |
| PRIMARY Number of Participants With Unexpected ADRs and SADRs |
15; 1 | — |
| PRIMARY Number of AEs According to Severity |
252; 339; 179; 48; 27 | — |
| PRIMARY Number of AEs According to Action Taken |
46; 3; 0; 319; 0; 477 | — |
| PRIMARY Number of AEs According to SAEs' Category |
27; 9; 45; 1; 0; 0 | — |
| PRIMARY Number of AEs According to Their Outcomes |
593; 0; 91; 153; 8 | — |
| PRIMARY Number of AEs Based on Causality of AEs to the Study Drug |
10; 13; 135; 686; 1; 0 | — |
| PRIMARY Number of AEs Based on Other Causality of AEs |
442; 19; 119; 106 | — |
| PRIMARY Number of Participants With AEs Classified According to Their Age at Baseline |
82; 17 | — |
| PRIMARY Number of Participants With AEs Classified According to Their Sex at Baseline |
39; 60 | — |
| PRIMARY Number of Participants With AEs Classified According to Their Diagnosis at Baseline |
32; 67; 0 | — |
| PRIMARY Number of Participants With AEs Classified According to Their Disease Status at Baseline |
9; 54; 28; 8 | — |
| PRIMARY Number of Participants With AEs Classified According to Their Renal Disorder Status at Baseline |
7; 92 | — |
| PRIMARY Number of Participants With AEs Classified According to Their Hepatic Disorder Status at Baseline |
20; 79 | — |
| PRIMARY Number of Participants With AEs Classified According to Their Allergic History Status at Baseline |
49; 50 | =0.9509 |
| PRIMARY Number of Participants With AEs Classified According to Their Veno-occlusive Liver Disease/ Sinusoidal Obstruction Syndrome (VOD /SOS) Status at Baseline |
0; 99 | — |
| PRIMARY Number of Participants With AEs Classified According to Their Previous Systemic Therapy Status at Baseline |
99; 0; 0 | — |
| PRIMARY Number of Participants With AEs Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline |
53; 46; 0 | — |
| PRIMARY Number of Participants With AEs Classified According to Usage of Concomitant Medication Throughout the Study |
99; 0 | — |
| PRIMARY Number of Elderly Participants With ADRs |
10 | — |
| SECONDARY Number of Participants With Best Overall Response (BOR) |
74; 20 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Their Age at Baseline |
59; 15 | =0.1488 |
| SECONDARY Number of Participants With Effective BOR Classified According to Sex at Baseline |
32; 42 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Their Diagnosis at Baseline |
22; 52; 0 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Their Disease Status at Baseline |
8; 40; 21; 5 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Their Renal Disorder at Baseline |
4; 70 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Their Hepatic Disorder at Baseline |
17; 57 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Their Allergic History at Baseline |
32; 42 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Their VOD/SOS Status at Baseline |
0; 74 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Their Previous Systemic Therapy Status at Baseline |
74; 0; 0 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline |
36; 38; 0 | — |
| SECONDARY Number of Participants With Effective BOR Classified According to Usage of Concomitant Medication Throughout the Study |
74; 0 | — |
Summary
Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.
Eligibility Criteria
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study:
- Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.
- Patients to whom BESPONSA® is contraindicated as per the local labeling.
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Data sourced from ClinicalTrials.gov (NCT04307134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.