Trial Outcomes & Findings for BESPONSA Injection 1 mg Special Investigation (NCT NCT05923112)
NCT ID: NCT05923112
Last Updated: 2025-12-05
Results Overview
An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to BESPONSA Injection 1mg in a participant who received BESPONSA Injection 1mg. A serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: results in death; is life-threatening; requires inpatient hospitalization or prolongation of hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
COMPLETED
421 participants
From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
2025-12-05
Participant Flow
421 participants were considered to be enrolled because they used this drug after marketing. CRFs were collected from 383 of these participants. Although data were analyzed from 383 participants for all-case surveillance, only 136 participants provided informed consent for results disclosure and are reported in the record.
Participant milestones
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and overall survival (OS). The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo hematopoietic stem cell transplant (HSCT) within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for venoocclusive disease (VOD)/sinusoidal obstruction syndrome (SOS), and effectiveness was observed as survival time.
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|---|---|
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Overall Study
STARTED
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383
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Overall Study
COMPLETED
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136
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Overall Study
NOT COMPLETED
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247
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Reasons for withdrawal
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and overall survival (OS). The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo hematopoietic stem cell transplant (HSCT) within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for venoocclusive disease (VOD)/sinusoidal obstruction syndrome (SOS), and effectiveness was observed as survival time.
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|---|---|
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Overall Study
Protocol Violation
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4
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Overall Study
No informed consent on publication of study results
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243
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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|---|---|
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Age, Customized
<15 years
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11 participants
n=136 Participants
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Age, Customized
≥15 and <65 years
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61 participants
n=136 Participants
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Age, Customized
≥65 years
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64 participants
n=136 Participants
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Sex: Female, Male
Female
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69 Participants
n=136 Participants
|
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Sex: Female, Male
Male
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67 Participants
n=136 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeksPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to BESPONSA Injection 1mg in a participant who received BESPONSA Injection 1mg. A serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: results in death; is life-threatening; requires inpatient hospitalization or prolongation of hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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The Incidence of Adverse Drug Reactions
ADR
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72 Participants
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The Incidence of Adverse Drug Reactions
SADR
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21 Participants
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PRIMARY outcome
Timeframe: No HSCT: up to 52 weeks, HSCT: up to 104 weeksPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
Risk ratios for the proportion of participants with ADRs in different subgroups were determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. ADRs meeting definition of liver disorder including safety specification events of VOD/SOS were analyzed by each of the following factors: Age; Hepatic impairment; Medical history (past) - VOD/SOS, Hepatitis or hepatic disease; Medical history (present) - VOD/SOS, Hepatitis or hepatic disease; Eastern Cooperative Oncology Group performance status (ECOG PS); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels; gamma glutamyl transpeptidase (γ-GTP) level; Total bilirubin level; Platelet count; Peripheral blast count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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The Incidence of Liver Disorder Including VOD/SOS (ADRs)/ (All CTCAE Grades)
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25 Participants
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PRIMARY outcome
Timeframe: No HSCT: up to 52 weeks, HSCT: up to 104 weeksPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. ADRs meeting definition of liver disorder including safety specification events of VOD/SOS were analyzed by each of the following factors: Age; Hepatic impairment; Medical history (past) - VOD/SOS, Hepatitis or hepatic disease; Medical history (present) - VOD/SOS, Hepatitis or hepatic disease; ECOG PS; AST and ALT levels; γ-GTP level; Total bilirubin level; Platelet count; Peripheral blast count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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The Incidence of Liver Disorder Including VOD/SOS (ADRs)/ (CTCAE Grade 3 or Higher)
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15 Participants
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PRIMARY outcome
Timeframe: From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participantsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. ADRs meeting definition of safety specification events of myelosuppression were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \> 1.8 mg/m2; ECOG PS; White blood cell count; Neutrophil count; Platelet count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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The Incidence of Myelosuppression (ADRs)/ (All CTCAE Grades)
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52 Participants
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PRIMARY outcome
Timeframe: From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participantsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. ADRs meeting definition of safety specification events of myelosuppression were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \> 1.8 mg/m2; ECOG PS; White blood cell count; Neutrophil count; Platelet count; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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The Incidence of Myelosuppression (ADRs)/ (CTCAE Grade 3 or Higher)
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43 Participants
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PRIMARY outcome
Timeframe: From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participantsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. In category (B) The risk ratio and confidence interval could not be estimated because no ADRs were observed in either the numerator, the denominator, or both. ADRs meeting definition of safety specification events of infection were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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The Incidence of Infections (ADRs)/ (All CTCAE Grades)
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7 Participants
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PRIMARY outcome
Timeframe: From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participantsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. In category (B) The risk ratio and confidence interval could not be estimated because no ADRs were observed in either the numerator, the denominator, or both. ADRs meeting definition of safety specification events of infection were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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The Incidence of Infections (ADRs)/ (CTCAE Grade 3 or Higher)
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4 Participants
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PRIMARY outcome
Timeframe: From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participantsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. In category(A) The risk ratio was calculable; however, the confidence interval could not be estimated due to the absence of ADRs in the numerator. In category (B) The risk ratio and confidence interval could not be estimated because no ADRs were observed in either the numerator, the denominator, or both. ADRs meeting definition of safety specification events of hemorrhage were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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The Incidence of Hemorrhage (ADRs)/ (All CTCAE Grades)
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2 Participants
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PRIMARY outcome
Timeframe: From the start date of administration to Day 28 post-final dose, approximately 27 weeks for HSCT and no HSCT participantsPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
Risk ratios for the proportion of participants with ADRs in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. ADRs meeting definition of safety specification events of hemorrhage were analyzed by each of the following factors: Age; Hepatic impairment; Renal impairment; Total dose per cycle \> 1.8 mg/m2; ECOG PS; Salvage line of the induction treatment with this drug; HSCT before the start of this drug.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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The Incidence of Hemorrhage (ADRs)/ (CTCAE Grade 3 or Higher)
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0 Participants
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PRIMARY outcome
Timeframe: Within 100 days or greater than 100 days after the first HSCT after the start of BESPONSA 1 mg injection up to 52 weeksPopulation: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received BESPONSA Injection 1mg at least once. Participants with protocol violation and without informed consent on publication of study results were excluded.
Risk ratios for the proportion of participants with early death in different subgroups was determined. However, if there was a category with fewer than 10 participants and it was considered difficult to determine the risk ratio for that category after reconsideration, the risk ratio was not determined for that category. Participants in the safety analysis set who underwent HSCT after the start of BESPONSA Injection 1mg and have completed the study were included in the analysis. Early death after HSCT was defined as death occurring within 100 days after the first HSCT following the start of BESPONSA Injection 1mg. Early death was considered to be absent if the participant died on Day 101 or later, or was confirmed alive at the time of study completion/discontinuation.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=39 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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Early Death After HSCT
Death after HSCT in participants who underwent HSCT after starting treatment
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18 participants
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Early Death After HSCT
Death within 100 days post-HSCT in participants who died after HSCT
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10 participants
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Early Death After HSCT
Death after > 100 days post-HSCT in participants who died after HSCT
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8 participants
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SECONDARY outcome
Timeframe: 52 Weeks. However, if subsequent treatment for the target disease was started or HSCT was performed, the best overall response before the start of the subsequent treatment or HSCT, whichever was earlier, was entered.Population: The effectiveness analysis set excluded participants in the safety analysis set who had diseases that were outside the scope of the study. Participants without informed consent on publication of study results were excluded.
The best overall response was evaluated for its clinical effect of hematologic remission during the observation period. The proportions of CR or CRi and their 95% confidence intervals were determined. However, if subsequent treatment for the target disease was started or HSCT was performed, the best overall response before the start of the subsequent treatment or HSCT, whichever occurred earlier, was recorded.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=131 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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|---|---|
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Hematologic Remission Rate
|
61.8 Percentage
Interval 52.9 to 70.2
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SECONDARY outcome
Timeframe: No HSCT: up to 52 weeks, HSCT: up to 104 weeksPopulation: The effectiveness analysis set excluded participants in the safety analysis set who had diseases that were outside the scope of the study. Participants without informed consent on publication of study results were excluded.
OS was defined and evaluated as the number of months from the start of BESPONSA Injection 1mg to all-cause death. The participant's survival status was confirmed at the time of completion or discontinuation of the study. The endpoint was censored on the day when participant's survival was last confirmed. For time-to-event data, the median was determined using the Kaplan-Meier method.
Outcome measures
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=131 Participants
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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|---|---|
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Overall Survival (OS)
|
10.28 Months
Interval 7.46 to 16.49
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Adverse Events
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
Serious adverse events
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 participants at risk
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
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Blood and lymphatic system disorders
Aplastic anaemia
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Blood and lymphatic system disorders
Cytopenia
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Blood and lymphatic system disorders
Neutropenia
|
2.9%
4/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Blood and lymphatic system disorders
Pancytopenia
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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Cardiac disorders
Cardiac failure
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Liver disorder
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
9.6%
13/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Bacteraemia
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Intervertebral discitis
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia
|
1.5%
2/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Viraemia
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Neutrophil count decreased
|
1.5%
2/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Platelet count decreased
|
2.9%
4/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
11.0%
15/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemic infiltration extramedullary
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.74%
1/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
Other adverse events
| Measure |
BESPONSA Injection 1mg (Inotuzumab Ozogamicin)
n=136 participants at risk
Participants who received BESPONSA Injection 1mg as indicated in the approved local product document were observed for up to 104 weeks. The dosage can be adjusted as per physician's discretion. The observation period was divided into two phases: the treatment phase and the follow-up phase. The treatment phase was from the first day of treatment to 28 days after the last treatment, and safety was observed for adverse events, and effectiveness was observed for hematological response and OS. The follow-up phase was from the 29th day after the last administration to week 52 for participants who did not undergo HSCT within 52 weeks of the start of administration, or was up to 52 weeks after HSCT for participants who underwent HSCT within 52 weeks of the start of administration. Safety was observed for VOD/SOS, and effectiveness was observed as survival time.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
8/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.6%
13/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
2.2%
3/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.7%
5/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
4/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
9/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
4/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Malaise
|
2.9%
4/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
General disorders
Pyrexia
|
7.4%
10/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.9%
4/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Herpes simplex
|
1.5%
2/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Infections and infestations
Pneumonia
|
2.2%
3/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.2%
3/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Alanine aminotransferase increased
|
6.6%
9/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Amylase increased
|
2.2%
3/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
5/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
1.5%
2/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.7%
5/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Hepatic enzyme increased
|
1.5%
2/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Neutrophil count decreased
|
11.8%
16/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
Platelet count decreased
|
20.6%
28/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Investigations
White blood cell count decreased
|
6.6%
9/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
3/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Dizziness
|
1.5%
2/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Nervous system disorders
Headache
|
1.5%
2/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
2/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
2/136 • From first dose up to 28 days after last dose. VOD/SOS: No HSCT: up to 52 weeks, HSCT: up to 104 weeks
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER