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The purpose of this study is to describe the demographics and clinical characteristics, treatment pathway, and effectiveness and safety of inotuzumab ozogamicin in patients with relapsed/refractory B-cell acute lymphoblastic leukaemia treated with inotuzumab ozogamicin in the real-world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult R/R ALL patients who have received InO | Relapsed/refractory ALL patients who are 18 years and over and initiated InO between 1st of June 2016 and date of data collection (to be confirmed). They will have accessed InO treatment via NHS commissioning, via the CUP, or via private purchase and will have at least 3 months follow up from the index date unless death occurs within that time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inotuzumab Ozogamicin | Drug | Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline | In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported. | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Number of Lines of Salvage Therapy | In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported. | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) | In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported. | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Type of Conditioning Regimen for Each HSCT | In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported. | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Measure | Description | Time Frame |
|---|---|---|
| Total Duration of Treatment With Inotuzumab Ozogamicin | In this outcome measure, total duration of InO treatment was reported. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with relapsed/refractory Acute Lymphoblastic Leukemia who are aged 18 and over and initiated Inotuzumab Ozogamicin between 1st of June 2016 and date of data collection and received treatment via NHS commissioning, via the Compassionate Use Programme, or via private purchase.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Bristol NHS Foundation Trust | Bristol | BS1 3NU | United Kingdom | |||
| University College London Hospital NHS Foundation Trust |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants who initiated treatment with inotuzumab ozogamicin (InO) for relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), in real world settings as a part of routine clinical care, between June 2016 and January 2021, were included. Data of these participants, were retrieved from hospital records and observed in this retrospective, observational study for approximately 1 year duration.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inotuzumab Ozogamicin (InO) | Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The full analysis set (FAS) comprised of medical records extracted for the purpose of the study from all eligible participants who were included in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Inotuzumab Ozogamicin (InO) | Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline | In this outcome measure, number of participants who were treated with the first-line chemotherapy during anytime between initial diagnosis of ALL and InO initiation, were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study
Same event may appear as both an AE and a serious AE. 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 a serious and non-serious event during the study. AEs were reported as per participants' medical records. There was no specific medical dictionary.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inotuzumab Ozogamicin (InO) | Participants with relapsed/refractory B-cell ALL, were treated with InO in real world settings as part of routine clinical care, between June 2016 to January 2021. Data of these participants were studied for approximately 1 year in this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 18, 2019 | Jan 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2020 | Jan 27, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000080045 | Inotuzumab Ozogamicin |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Number of Participants Who Were Treated Previously With Blinatumomab | In this outcome measure, number of participants who were previously treated with blinatumomab, were reported. | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies | In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported. | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles | In this outcome measure, number of participants were classified according to total number of InO treatment cycles received. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles | In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | In this outcome measure, number of participants according to prescribed starting InO dose, were reported. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy | In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Duration of Concomitant Azole Antifungal Therapy | In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment | CR was defined as documented in medical records or (if unavailable in the records) as less than (<) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to [>=] 100*10^9 cells per liter [/L] and absolute neutrophil counts [ANC] >=1*10^9 cells/L) and resolution of any extramedullary disease. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment | CRi was defined as documented in medical records or (if unavailable in the records) <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100* 10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants With CR/CRi by the End of InO Treatment | In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Median Time to CR/CRi | CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi | 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. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Achieved Negative MRD Classified Per InO Cycles | Negative MRD (among those who had CR/CRi) 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. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation | In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported. | At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Classified According to Their Cause of Death | In this outcome measure, number of participants according to their cause of death were reported. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Overall Survival (OS) | OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis. | InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation | Relapse free survival: the time from the start of treatment to 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), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9/L and ANC >=1*10^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9/L and ANC <1*10^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. | At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Relapse-free Survival (RFS) | RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells /L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. | From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Time to Non-relapse Mortality (NRM) | NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse. | Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment | In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies. | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not >50%. | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Survived Post InO Blinatumomab Treatment | In this outcome measure, number of participants who survived at completion of InO treatment were reported. | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants With Interrupted InO Treatment Due to VOD/SOS | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants With Moderate Severity VOD/SOS | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study |
| Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation | Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation | AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records. | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT | Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| Number of Participants With Significant Risk Factors for VOD/SOS | In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
| London |
| NW1 2PG |
| United Kingdom |
| The Royal Marsden NHS Foundation Trust of Fulham Road | London | SW3 6JJ | United Kingdom |
| Taunton and Somerset NHS Foundation Trust of Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Time from ALL Diagnosis to Index Date | Here, time from ALL diagnosis to index date was reported. Index date: date of initiation of the first cycle of InO. | Mean | Standard Deviation | Years |
|
| Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) | ECOG PS is used to measure quality of life of oncology participants with scores ranging from 0 to 5;where 0= fully active, able to carry on all pre-disease performance without restriction;1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work;2= ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (>)50 percent (%) of waking hours;3= capable of only limited self-care, confined to bed or chair >50% of waking hours;4= completely disabled, cannot carry on any self-care, totally confined to bed or chair;5= dead. | Count of Participants | Participants |
|
| Number of Participants According to Their Phase of Disease at Index Date | Here, number of participants are classified according to phase of ALL disease: complete remission (CR), 1st relapse, 2nd relapse, 3rd relapse, 4th or greater relapse. Remission = either the reduction or disappearance of the signs and symptoms of a disease. Relapse = return of a disease or the signs and symptoms of a disease after a period of improvement. Index date: date of initiation of the first cycle of InO. | Count of Participants | Participants |
|
| Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period | Here, number of participants are classified according to their history of liver disease prior to index date, as 1) No = no previous liver disease history, 2) Yes = previous liver disease history and 3) Not know. Prior to index date period: time post ALL diagnosis to index date. Index date: date of initiation of the first cycle of InO. | Count of Participants | Participants |
|
| Percentage of Positive Cell Blasts (CD22 expression test) | Here number analyzed signifies participants evaluable for this baseline characteristic. | Mean | Standard Deviation | Percentage of cells |
|
| Number of Participants According to ALL Mutation Types | Here, number of participants were classified per ALL mutation type. | Count of Participants | Participants |
|
| Blood Platelet Counts | Mean | Standard Deviation | cells*10^9 per liter |
|
| Blood Absolute Neutrophil Counts | Here number analyzed signifies participants evaluable for this baseline characteristic. | Mean | Standard Deviation | cells*10^9 per liter |
|
| Blood Alanine Aminotransferase (ALT) Levels | Mean | Standard Deviation | International units per liter (IU/L) |
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| Blood Aspartate Aminotransferase (AST) Levels | Here number analyzed signifies participants evaluable for this baseline characteristic. | Mean | Standard Deviation | International units per liter |
|
| Blood Bilirubin Levels | Here number analyzed signifies participants evaluable for this baseline characteristic. | Mean | Standard Deviation | Milligrams per deciliter (mg/dL) |
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| Blood Albumin Levels | Mean | Standard Deviation | Grams per deciliter (g/dL) |
|
| Blood Gamma Glutamyl Transferase (GGT) | Here number analyzed signifies participants evaluable for this baseline characteristic. | Mean | Standard Deviation | Units per liter (U/L) |
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| Blood Alkaline Phosphatase (ALP) Levels | Here number analyzed signifies participants evaluable for this characteristic. | Mean | Standard Deviation | International units per liter |
|
| Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period | Here, number of participants are classified according to number of relapses of ALL relapse prior to index date. Prior to index date period: time post ALL diagnosis to index date. Index date: date of initiation of the first cycle of InO. | Count of Participants | Participants |
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| Primary | Number of Participants According to Number of Lines of Salvage Therapy | In this outcome measure, number of participants according to number of lines of salvage therapy anytime between initial diagnosis of ALL and InO initiation, were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Primary | Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) | In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.5 years); retrieved data was analyzed during 12 months of this observational study |
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| Primary | Number of Participants According to Type of Conditioning Regimen for Each HSCT | In this outcome measure, number of participants were classified according to different type of conditioning regimen for each HSCT (high-dose intensity myeloablative, reduced-intensity/non-myeloablative), were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure who had at least 1 line of prior HSCT recorded. | Posted | Count of Participants | Participants | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Primary | Number of Participants Who Were Treated Previously With Blinatumomab | In this outcome measure, number of participants who were previously treated with blinatumomab, were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Primary | Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies | In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | Anytime between initial diagnosis of ALL and InO initiation, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Total Duration of Treatment With Inotuzumab Ozogamicin | In this outcome measure, total duration of InO treatment was reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Mean | Standard Deviation | Days | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles | In this outcome measure, number of participants were classified according to total number of InO treatment cycles received. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles | In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies number of participants evaluable for specified rows. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | In this outcome measure, number of participants according to prescribed starting InO dose, were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for specific rows. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Secondary | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, number analyzed signifies participants evaluable for specific rows. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
| Secondary | Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy | In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
| Secondary | Duration of Concomitant Azole Antifungal Therapy | In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure and were treated with concomitant azole antifungal therapy. | Posted | Mean | Standard Deviation | Days | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Secondary | Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment | CR was defined as documented in medical records or (if unavailable in the records) as less than (<) 5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets greater than or equal to [>=] 100*10^9 cells per liter [/L] and absolute neutrophil counts [ANC] >=1*10^9 cells/L) and resolution of any extramedullary disease. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Secondary | Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment | CRi was defined as documented in medical records or (if unavailable in the records) <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100* 10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Secondary | Number of Participants With CR/CRi by the End of InO Treatment | In this outcome, number of participants who achieved CR/CRi at the end of InO treatment are reported. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
| Secondary | Median Time to CR/CRi | CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi. | Posted | Median | 95% Confidence Interval | Months | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi | 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. This outcome measure was analyzed in participants with CR/CRi. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with CR/CRi. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Number of Participants Who Achieved Negative MRD Classified Per InO Cycles | Negative MRD (among those who had CR/CRi) 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. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'overall number of participants analyzed' signifies participants evaluable for this outcome measure with negative MRD. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation | In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | At 3, 6, and 12 months post InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Number of Participants Classified According to Their Cause of Death | In this outcome measure, number of participants according to their cause of death were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from the index date to the date of death. Participants were censored at date of latest visit at the time of data collection. Kaplan-Meier method was used for OS analysis. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Median | 95% Confidence Interval | Months | InO initiation date to death due to any cause or last visit at time of data collection, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation | Relapse free survival: the time from the start of treatment to 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), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR: documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9/L and ANC >=1*10^9/L) and resolution of any extramedullary disease. CRi: documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9/L and ANC <1*10^9/L) and resolution of any extramedullary disease. Progressive disease (PD): a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 3, 6, and 12 months from InO initiation date, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Relapse-free Survival (RFS) | RFS was defined as the time from the start of treatment to earliest date of the following events: death, PD (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi; as documented in medical records. CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells /L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD: a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Median | 95% Confidence Interval | Months | From InO initiation date to death or progressive disease, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Time to Non-relapse Mortality (NRM) | NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall number of Participants" signifies evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | Post InO treatment from date of follow up HSCT to death, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment | In this outcome measure, number of participants according to therapies they initiated post InO treatment were reported. One participant could have more than 1 type of therapies. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | CR was defined as documented in medical records or as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets >=100*10^9 cells/L and ANC >=1*10^9 cells/L) and resolution of any extramedullary disease. CRi was defined as documented in medical records or <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100*10^9 cells/L and ANC <1*10^9 cells/L) and resolution of any extramedullary disease. PD was defined as a doubling of peripheral blasts with an absolute increase of >5*10^9 cells/L. Stable disease was defined as increase of peripheral blasts with an absolute increase not >50%. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'number analyzed' signifies participants evaluable for each category. | Posted | Count of Participants | Participants | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Number of Participants Who Survived Post InO Blinatumomab Treatment | In this outcome measure, number of participants who survived at completion of InO treatment were reported. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| Secondary | Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS. | Posted | Count of Participants | Participants | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS. | Posted | Count of Participants | Participants | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Number of Participants With Interrupted InO Treatment Due to VOD/SOS | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Post InO treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
|
| Secondary | Number of Participants With Moderate Severity VOD/SOS | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with VOD/SOS. | Posted | Count of Participants | Participants | Post InO Treatment, during data identification period from June 2016 to January 2021 (approximately 4.5 years); from the data collected and observed retrospectively over approximately 12 months of this study |
|
|
|
| Secondary | Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation | Adverse event (AE) was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records. | Safety analysis set (SAS) included the medical records extracted for the purpose of the study from all eligible participants who were included in the study and had at least one dose of study medication. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Secondary | Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation | AE was defined as any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 were severe events. Grade 4 were life-threatening events. Information for grades was recorded as per participants' medical records. | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure with Grade 3 or 4 TRAE. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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|
| Secondary | Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Secondary | Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Prior to post InO HSCT, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
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| Secondary | Number of Participants With Significant Risk Factors for VOD/SOS | In this outcome measure, participants with significant risk factor for VOD/ SOS occurrence were reported. VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked | FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for each category. | Posted | Count of Participants | Participants | From InO initiation date to date of end of treatment, during data identification period from June 2016 to January 2021 (approximately 4.7 years); retrieved data was analyzed during 12 months of this observational study |
|
|
|
| 19 |
| 28 |
| 2 |
| 28 |
| 2 |
| 28 |
| Liver | General disorders | Systematic Assessment |
|
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 the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Received Total of 4 Cycles |
|
| Received Total of 5 Cycles |
|
| Received Total of 6 Cycles |
|
|
| Cycle 1:Interrupted Due to Liver toxicity Treatment Related Adverse Events (TRAEs) |
|
|
| Cycle 1: Interrupted Due to Neutropenia and Severe Constipation |
|
|
| Cycle 1: Interrupted Due to SARS-CoV 2 infection |
|
|
| Cycle 2: Cycle was not Interrupted |
|
|
| Cycle 2: Interrupted Due to High Fever, Rigors, Vomiting, Hypotension |
|
|
| Cycle 2: Interrupted Due to Liver Toxicity TRAE(s) |
|
|
| Cycle 2: Interrupted Due to Nausea, Poor oral intake, Neutropenic Sepsis |
|
|
| Cycle 3: Cycle was not Interrupted |
|
|
| Cycle 3: Interrupted Due to Infection in Peripherally Inserted Central Catheter |
|
|
| Cycle 3: Interrupted Due to Transferred to Another Hospital |
|
|
|
| Cycle 2: 1.0 mg/m2 |
|
|
| Cycle 2: 1.2 mg/m^2 |
|
|
| Cycle 2: 1.5 mg/m^2 |
|
|
| Cycle 2: 1.8 mg/m^2 |
|
|
| Cycle 3: 1.5 mg/m^2 |
|
|
| Cycle 3: 1.8 mg/m^2 |
|
|
| Cycle 4: 0.5 mg/m^2 |
|
|
| Cycle 4: 1.5 mg/m^2 |
|
|
| Cycle 5: 1.5 mg/m^2 |
|
|
| Cycle 6: 1.5 mg/m^2 |
|
|
| Cycle 2 |
|
|
| Cycle 3 |
|
|
| Cycle 4 |
|
|
| Cycle 5 |
|
|
| Cycle 6 |
|
|
| Title | Measurements |
|---|
|
| Subarachnoid/Intraparenchymal Hemorrhage Stroke |
|
| Veno-Occlusive Disease |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| HSCT: Not Known |
|
|
| CAR-T cell therapy: CR |
|
|
| CAR-T cell therapy: CRi |
|
|
| CAR-T cell therapy: PD |
|
|
| CAR-T cell therapy: Not Known |
|
|
| Blinatumomab: CR |
|
|
| Blinatumomab: Not Recorded |
|
|
| Blinatumomab: PD |
|
|
| Blinatumomab: SD |
|
|
| Other Chemotherapy: CR |
|
|
| Other Chemotherapy: CRi |
|
|
| Other Chemotherapy: Missing |
|
|
| Other Chemotherapy: Not Recorded |
|
|
| Other Chemotherapy: PD |
|
|
| Other Chemotherapy: SD |
|
|
| Number of alkylating agents: 3 |
|
|
| Busulfan-containing regimen |
|
|
| Last bilirubin concentration prior to follow-up HSCT: > upper limit normal (ULN) |
|
|
| Last bilirubin concentration prior to follow-up HSCT: <ULN |
|
|
| Last bilirubin concentration prior to follow-up HSCT: Missing |
|
|
| Age: <55 years |
|
|
| Age: >55 years |
|
|
| Last ALT concentration prior to follow-up HSCT: less than or equal to (≤)1.5 ULN |
|
|
| Last ALT concentration prior to follow-up HSCT: Missing |
|
|
| Last AST concentration prior to follow-up HSCT: ≤1.5 ULN |
|
|
| Last AST concentration prior to follow-up HSCT: Missing |
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