N/A
Completed N=383
BESPONSA Injection 1 mg Special Investigation
Source: ClinicalTrials.gov NCT05923112 ↗Enrolled (actual)
383
Serious AEs
31.6%
Results posted
Dec 2025
Primary outcomePrimary: The Incidence of Adverse Drug Reactions — 72; 21 Participants
Summary
The purpose of this study is to learn about the safety and effectiveness of BESPONSA. BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia.
Registration criteria for this study is all patients who starting BESPONSA in Japan from its launch to the market to April 30, 2020.
All patients in this study will receive BESPONSA according to the prescriptions.
Patients will be followed up as follow.
* 52 weeks for patients who did not have a HSCT (Hematopoietic Stem Cell Transplant) within 52 weeks after starting BESPONSA.
* Up to 52 weeks after a HSCT for patients who had a HSCT within 52 weeks after starting BESPONSA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Adverse Drug Reactions |
72; 21 | — |
| PRIMARY The Incidence of Liver Disorder Including VOD/SOS (ADRs)/ (All CTCAE Grades) |
25 | — |
| PRIMARY The Incidence of Liver Disorder Including VOD/SOS (ADRs)/ (CTCAE Grade 3 or Higher) |
15 | — |
| PRIMARY The Incidence of Myelosuppression (ADRs)/ (All CTCAE Grades) |
52 | — |
| PRIMARY The Incidence of Myelosuppression (ADRs)/ (CTCAE Grade 3 or Higher) |
43 | — |
| PRIMARY The Incidence of Infections (ADRs)/ (All CTCAE Grades) |
7 | — |
| PRIMARY The Incidence of Infections (ADRs)/ (CTCAE Grade 3 or Higher) |
4 | — |
| PRIMARY The Incidence of Hemorrhage (ADRs)/ (All CTCAE Grades) |
2 | — |
| PRIMARY The Incidence of Hemorrhage (ADRs)/ (CTCAE Grade 3 or Higher) |
— | — |
| PRIMARY Early Death After HSCT |
18; 10; 8 | — |
| SECONDARY Hematologic Remission Rate |
61.8 | — |
| SECONDARY Overall Survival (OS) |
10.28 | — |
Eligibility Criteria
Inclusion Criteria
- All patients prescribed BESPONSA
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT05923112). 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. Informational only — not medical advice.