Trial Outcomes & Findings for A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment (NCT NCT05597085)
NCT ID: NCT05597085
Last Updated: 2025-02-04
Results Overview
CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
COMPLETED
32 participants
From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
2025-02-04
Participant Flow
Data of eligible Indian participants with Relapsed/Refractory/ B Cell Acute lymphoblastic leukemia (R/R B cell ALL), who aged greater than or equal to 18 years at the time of initiating treatment with Inotuzumab ozogamicin (InO) \[index date\], was collected retrospectively from hospital medical records. For eligibility Index date could have been between Feb 2017 to Feb 2022. Available data was retrieved from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months) in the current observational study.
Participant milestones
| Measure |
Inotuzumab Ozogamicin (InO)
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Age, Customized
18-50 years
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23 Participants
n=32 Participants
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Age, Customized
Above (>) 50 years
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9 Participants
n=32 Participants
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Sex: Female, Male
Female
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11 Participants
n=32 Participants
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Sex: Female, Male
Male
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21 Participants
n=32 Participants
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PRIMARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO
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19 Participants
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PRIMARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation
Participants achieved CR/CRi during first salvage therapy
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6 Participants
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Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation
Participants achieved CR/CRi during second salvage therapy
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11 Participants
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Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation
Participants achieved CR/CRi during third salvage therapy
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2 Participants
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PRIMARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9 cells/L and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of bone marrow blasts (BMB). In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease
Participants achieved CR/CRi: BMB <50%
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10 Participants
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Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease
Participants achieved CR/CRi: BMB >=50%
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9 Participants
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolor flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=19 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi
Participants with CR who achieved MRD
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17 Participants
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Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi
Participants with CRi who achieved MRD
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1 Participants
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. Participants with either CR or CRi who achieved MRD negativity classified per number of lines of salvage therapies are reported in this outcome measure.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=19 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi
First Salvage Therapy
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5 Participants
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Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi
Second Salvage Therapy
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11 Participants
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Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi
Third Salvage Therapy
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2 Participants
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. Participants with either CR or CRi who achieved MRD negativity classified per high burden and low burden disease are reported in this outcome measure.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=19 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi
BMB <50%
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10 Participants
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Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi
BMB >=50%
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8 Participants
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=2 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years)
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2 Participants
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
The median number of cycles of InO a participant received during treatment were included. Standard dose of InO: 1.8 mg/m\^2 per 21 days cycle.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Median Number of Cycles of InO Treatment
|
2 Cycles of InO Treatment
Interval 1.0 to 6.0
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=19 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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Median Number of Cycles of InO Needed to Attain CR/CRi
|
2 Cycles of InO treatment
Interval 1.0 to 6.0
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=19 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies
First Salvage Therapy
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2.33 Cycles of InO treatment
Standard Deviation 1.21
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Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies
Second Salvage Therapy
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2.00 Cycles of InO treatment
Standard Deviation 1.48
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Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies
Third Salvage Therapy
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3.50 Cycles of InO treatment
Standard Deviation 3.54
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Remission was defined as either the reduction or disappearance of the signs and symptoms of leukemia for this study.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=17 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Duration of Remission (DOR)
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6 Months
Interval 0.5 to 61.0
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Standard dose of InO was 1.8 milligrams (mg) per meter square (m\^2) per cycle. Under dose of InO was less than 1.8 mg/m\^2 per cycle. Overdose of InO was more than 1.8 mg/m\^2 per cycle.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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Number of Participants Categorized as Per InO Doses
Under Dose
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17 Participants
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Number of Participants Categorized as Per InO Doses
Standard Dose
|
12 Participants
|
|
Number of Participants Categorized as Per InO Doses
Overdose
|
3 Participants
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Number of participants for whom there was deviation in InO dose from the standard dose (1.8 mg/ m\^2 per cycle) were included.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Number of Participants With InO Dose Modifications
Below standard dose
|
17 Participants
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Number of Participants With InO Dose Modifications
Above standard dose
|
3 Participants
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Concomitant medication was defined as any medication other than, and in addition to, the study medication taken for any period of time during the treatment.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Number of Participants Who Received Concomitant Medications
|
0 Participants
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SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
HSCT is the transplantation of multipotent hematopoietic stem cells to treat some type of cancers and other diseases.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT)
|
11 Participants
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SECONDARY outcome
Timeframe: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Survival rate: percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9 cells/L and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. In this outcome measure percentage of participants who had either CR or CRi with MRD negativity and survived at the end of 6 months and 12 months post initiation of InO treatment are reported on the basis of transplantation status.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=18 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity
Transplanted Participants: Survival rate at 6 Months
|
66.7 Percentage of participants
|
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Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity
Non-transplanted Participants: Survival rate at 6 Months
|
88.9 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity
Transplanted Participants: Survival rate at 12 Months
|
33.3 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity
Non-transplanted Participants: Survival rate at 12 Months
|
44.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on number of lines of salvage therapies.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=30 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
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|---|---|
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Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Transplanted participants: second salvage therapy: Survival rate at 6 months
|
66.7 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Transplanted participants: third salvage therapy: Survival rate at 6 months
|
50 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Transplanted participants: second salvage therapy: Survival rate at 12 months
|
33.3 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Transplanted participants: third salvage therapy: Survival rate at 12 months
|
50 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Non-transplanted participants: first salvage therapy: Survival rate at 6 months
|
56 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Non-transplanted participants: second salvage therapy: Survival rate at 6 months
|
25.0 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Non-transplanted participants: third salvage therapy: Survival rate at 6 months
|
50 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Non-transplanted participants: first salvage therapy: Survival rate at 12 months
|
33 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Non-transplanted participants: second salvage therapy: Survival rate at 12 months
|
12.5 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Non-transplanted participants: third salvage therapy: Survival rate at 12 months
|
50 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on high burden and low burden disease.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=30 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
Transplanted: BMB <50%: Survival rate at 6 Months
|
71.43 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
Transplanted: BMB >=50%: Survival rate at 6 Months
|
50 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
Transplanted: BMB <50%: Survival rate at 12 Months
|
42.86 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
Transplanted: BMB >=50%: Survival rate at 12 Months
|
25 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
Non-transplanted: BMB <50%: Survival rate at 6 Months
|
57.14 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
Non-transplanted: BMB >=50%: Survival rate at 6 Months
|
33.33 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
Non-transplanted: BMB <50%: Survival rate at 12 Months
|
28.57 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
Non-transplanted: BMB >=50%: Survival rate at 12 Months
|
25 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. In this outcome measure percentage of transplanted and non-transplanted participants greater than 65 years of age, who survived at the end of 6 months and 12 months post initiation of InO treatment are reported.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=2 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years)
Non-transplanted: >65 years: Survival rate at 6 Months
|
50.0 Percentage of participants
|
|
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years)
Non-transplanted: >65 years: Survival rate at 12 Months
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=17 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Number of Participants Categorized According to Cause of Death
Progression of disease
|
4 Participants
|
|
Number of Participants Categorized According to Cause of Death
Relapse
|
6 Participants
|
|
Number of Participants Categorized According to Cause of Death
Septic Shock
|
2 Participants
|
|
Number of Participants Categorized According to Cause of Death
Veno-occlusive disease (VOD)-related multiorgan failure
|
1 Participants
|
|
Number of Participants Categorized According to Cause of Death
VOD pneumonia
|
1 Participants
|
|
Number of Participants Categorized According to Cause of Death
Central nervous system (CNS) relapse
|
1 Participants
|
|
Number of Participants Categorized According to Cause of Death
Not mentioned
|
2 Participants
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.
RFS was defined as time from index date to the earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), or the start of new induction therapy or posttherapy HSCT without achieving CR/CRi. Index date was defined as the date of initiation of the first cycle of InO. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Median duration of relapse free survival in all participants included those participants who had achieved CR/CRi is reported in this outcome measure.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=17 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT
All Participants
|
7 Months
Interval 5.0 to 18.2
|
|
Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT
With Follow-up HSCT
|
6 Months
Interval 4.8 to 10.6
|
|
Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT
Without Follow-up HSCT
|
9.5 Months
Interval 2.5 to 29.5
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
VOD occurs when the small blood vessels in the liver are blocked.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=31 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD
Transplanted Participants
|
45.45 Percentage of participants
|
|
Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD
Non-transplanted Participants
|
10 Percentage of participants
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
VOD occurs when the small blood vessels in the liver are blocked. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies
First Salvage Therapy
|
20 Percentage of participants
|
|
Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies
Second Salvage Therapy
|
17 Percentage of participants
|
|
Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies
Third Salvage Therapy
|
50 Percentage of participants
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under "Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
VOD occurs when the small blood vessels in the liver are blocked. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease
BMB <50%
|
18.75 Percentage of participants
|
|
Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease
BMB >=50%
|
25.00 Percentage of participants
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
VOD occurs when the small blood vessels in the liver are blocked.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=2 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Percentage of Participants With VOD in Elderly Participants (>65 Years)
|
50.00 Percentage of participants
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Treatment-related AE was any untoward medical occurrence in a participant who has received the study drug. Liver toxicity parameters included: Aspartate aminotransferase (level) \>=2.5\*upper limit of normal (ULN); alanine transaminase (level) \>=2.5\*ULN and total serum bilirubin \>=1.5\*ULN. Here, Grade 3 indicates severe events and Grade 4 indicates Life-threatening events where urgent intervention was required.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Number of Participants With Grade 3/4 Treatment Related Liver Toxicity (Hepatobiliary Disorder) Adverse Events (TEAEs) Following InO Initiation
|
12 Participants
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
Hematological toxicities included: Febrile neutropenia= absolute neutrophil count (ANC) \< 1.0\*10\^9 cells/L, fever \>=38.5 degree C); Neutropenia= absolute granulocyte count \< 1.0\*10\^9 cells/L; Thrombocytopenia= platelet count \< 150,000 platelets per microliter.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Number of Participants With Hematological Toxicities Following InO Initiation
|
28 Participants
|
SECONDARY outcome
Timeframe: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. "Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Extramedullary disease was the presence of leukemic cell aggregates in the form of solid tumor outside that of bone marrow. Lymphoblastic lymphoma, was a clonal hematopoietic stem cell disorder of B or T cell origin. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Outcome measures
| Measure |
Inotuzumab Ozogamicin (InO)
n=2 Participants
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Number of Participants With Extramedullary Disease (EMD) or Lymphoblastic Lymphoma (LBL) Who Achieved CR or CRi
|
1 Participants
|
Adverse Events
Inotuzumab Ozogamicin (InO)
Serious adverse events
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 participants at risk
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
General disorders
Death
|
53.1%
17/32 • From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
AEs were reported as per participants' medical records. There was no specific medical dictionary.
|
|
General disorders
Veno Occlusive Disease (VOD)
|
21.9%
7/32 • From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
AEs were reported as per participants' medical records. There was no specific medical dictionary.
|
Other adverse events
| Measure |
Inotuzumab Ozogamicin (InO)
n=32 participants at risk
Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively.
|
|---|---|
|
Hepatobiliary disorders
Aspartate aminotransferase high
|
28.1%
9/32 • From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
AEs were reported as per participants' medical records. There was no specific medical dictionary.
|
|
Hepatobiliary disorders
Alanine aminotransferase high
|
18.8%
6/32 • From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
AEs were reported as per participants' medical records. There was no specific medical dictionary.
|
|
Hepatobiliary disorders
Bilirubin high
|
25.0%
8/32 • From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
AEs were reported as per participants' medical records. There was no specific medical dictionary.
|
|
Blood and lymphatic system disorders
Neutropenia
|
62.5%
20/32 • From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
AEs were reported as per participants' medical records. There was no specific medical dictionary.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
43.8%
14/32 • From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
AEs were reported as per participants' medical records. There was no specific medical dictionary.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
84.4%
27/32 • From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
AEs were reported as per participants' medical records. There was no specific medical dictionary.
|
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