Precursor Cell Lymphoblastic Leukemia-Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGInotuzumab Ozogamicin
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.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with relapsed/refractory ALL. * Patients who initiated InO between 1st of June 2016 and date of data collection. * Patients who accessed InO treatment via NHS commissioning, via the CUP, or via private purchase. * Patient aged ≥18 years old at initiation of InO treatment
Exclusion criteria
* Patients initiated on treatment with InO at a different hospital than the ones selected in this study. * Patients with \<3 months of follow-up since index date, unless death occurs \<3 months from index date.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline | 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 | 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. |
| Number of Participants According to Number of Lines of Salvage Therapy | 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 | 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. |
| Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) | 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 | In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported. |
| Number of Participants According to Type of Conditioning Regimen for Each HSCT | 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 | 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. |
| Number of Participants Who Were Treated Previously With Blinatumomab | 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 | In this outcome measure, number of participants who were previously treated with blinatumomab, were reported. |
| Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies | 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 | In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy | 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 | In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported. |
| Duration of Concomitant Azole Antifungal Therapy | 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 | In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported. |
| Number of Participants Who Achieved Complete Remission (CR) by the End 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 | 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. |
| Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End 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 | 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. |
| Number of Participants With CR/CRi by the End 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 | 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. |
| Median Time to CR/CRi | 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 | 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. |
| Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi | 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 | 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. |
| Number of Participants Who Achieved Negative MRD Classified Per InO 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 | 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. |
| Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation | 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 | In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported. |
| Number of Participants Classified According to Their Cause of Death | 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 | In this outcome measure, number of participants according to their cause of death were reported. |
| Overall Survival (OS) | 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 | 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. |
| Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation | 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: 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. |
| Relapse-free Survival (RFS) | 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 | 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. |
| Total Duration of Treatment With Inotuzumab Ozogamicin | 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 | In this outcome measure, total duration of InO treatment was reported. |
| Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment | 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 | 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. |
| Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | 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 | 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%. |
| Number of Participants Who Survived Post InO Blinatumomab Treatment | 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 | In this outcome measure, number of participants who survived at completion of InO treatment were reported. |
| Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment | 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 | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
| Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | 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 | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
| Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | 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 | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
| Number of Participants With Interrupted InO Treatment Due to VOD/SOS | 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 | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
| Number of Participants With Moderate Severity VOD/SOS | 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 | VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked. |
| Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) 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 | 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. |
| Number of Participants According to Types of Treatments Received for Grade3/4 TRAE 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 | 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. |
| 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 | 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 | 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 |
| Time to Non-relapse Mortality (NRM) | 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 | NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse. |
| Number of Participants According to Number of Inotuzumab Ozogamicin Treatment 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 | In this outcome measure, number of participants were classified according to total number of InO treatment cycles received. |
| Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment 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 | In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment. |
| Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | 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 | In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles. |
| Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | 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 | In this outcome measure, number of participants according to prescribed starting InO dose, were reported. |
| Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | 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 | In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded. |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Inotuzumab Ozogamicin (InO) | — |
|---|---|---|
| Age, Continuous | 46.8 Years STANDARD_DEVIATION 19.7 | — |
| Blood Absolute Neutrophil Counts | 4.1 cells*10^9 per liter STANDARD_DEVIATION 6.5 | — |
| Blood Alanine Aminotransferase (ALT) Levels | 37.9 International units per liter (IU/L) STANDARD_DEVIATION 35.3 | — |
| Blood Albumin Levels | 3.6 Grams per deciliter (g/dL) STANDARD_DEVIATION 0.7 | — |
| Blood Alkaline Phosphatase (ALP) Levels | 112.7 International units per liter STANDARD_DEVIATION 95.1 | — |
| Blood Aspartate Aminotransferase (AST) Levels | 29 International units per liter STANDARD_DEVIATION 2.8 | — |
| Blood Bilirubin Levels | 0.6 Milligrams per deciliter (mg/dL) STANDARD_DEVIATION 0.4 | — |
| Blood Gamma Glutamyl Transferase (GGT) | 74.8 Units per liter (U/L) STANDARD_DEVIATION 82.7 | — |
| Blood Platelet Counts | 95.9 cells*10^9 per liter STANDARD_DEVIATION 76.2 | — |
| Number of Participants According to ALL Mutation Types (1;19)(q23;p13) | 1 Participants | — |
| Number of Participants According to ALL Mutation Types BCR-ABL | 4 Participants | — |
| Number of Participants According to ALL Mutation Types Complex karyotype | 1 Participants | — |
| Number of Participants According to ALL Mutation Types Cytogenetics failed | 1 Participants | — |
| Number of Participants According to ALL Mutation Types ETV6 Rearrangement | 1 Participants | — |
| Number of Participants According to ALL Mutation Types Gain 18 centromere | 1 Participants | — |
| Number of Participants According to ALL Mutation Types Gain part of chr 5 | 1 Participants | — |
| Number of Participants According to ALL Mutation Types Not Known | 16 Participants | — |
| Number of Participants According to ALL Mutation Types Relapse with clonal evolution | 1 Participants | — |
| Number of Participants According to ALL Mutation Types t(8:14) | 1 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 | 5 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) 1 | 4 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) Not recorded | 19 Participants | — |
| Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period No | 22 Participants | — |
| Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period Not known | 5 Participants | — |
| Number of Participants According to History of Liver Disease Recorded for Prior to Index Date Period Yes | 1 Participants | — |
| Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period 1 | 21 Participants | — |
| Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period 2 | 5 Participants | — |
| Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period 3 | 1 Participants | — |
| Number of Participants According to Number of ALL Relapses Recorded for Prior to Index Date Period Not known | 1 Participants | — |
| Number of Participants According to Their Phase of Disease at Index Date CR | 0 Participants | — |
| Number of Participants According to Their Phase of Disease at Index Date First relapse | 21 Participants | — |
| Number of Participants According to Their Phase of Disease at Index Date Fourth or greater relapse | 0 Participants | — |
| Number of Participants According to Their Phase of Disease at Index Date Second relapse | 6 Participants | — |
| Number of Participants According to Their Phase of Disease at Index Date Third relapse | 1 Participants | — |
| Percentage of Positive Cell Blasts (CD22 expression test) | 49.6 Percentage of cells STANDARD_DEVIATION 29.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
| Time from ALL Diagnosis to Index Date | 2.6 Years STANDARD_DEVIATION 5.3 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 19 / 28 |
| other Total, other adverse events | 2 / 28 |
| serious Total, serious adverse events | 2 / 28 |
Outcome results
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Number of Lines of Salvage Therapy | 1 | 6 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Number of Lines of Salvage Therapy | 2 | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Number of Lines of Salvage Therapy | No salvage therapy | 21 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) | At least one line of prior HSCT recorded | 10 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) | No prior HSCT | 15 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prior Hematopoietic Stem Cell Transplant (HSCT) | Not recorded | 3 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Type of Conditioning Regimen for Each HSCT | High-dose intensity myeloablative | 7 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Type of Conditioning Regimen for Each HSCT | Not known | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Type of Conditioning Regimen for Each HSCT | Reduced intensity/ non-myeloablative | 2 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies | Participants with prior CAR T-Cell therapy | 0 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies | Participants with no prior CAR T-Cell therapy | 18 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Treated With Chimeric Antigen Receptor (CAR) T-Cell Therapies | Not recorded | 10 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline | At least one line of prior chemotherapy recorded | 27 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Received First Line Chemotherapy According to National Trial or Treatment Guideline | Not recorded | 1 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Were Treated Previously With Blinatumomab | Prior treatment with blinatumomab | 4 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Were Treated Previously With Blinatumomab | No prior treatment with Blinatumomab | 24 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Duration of Concomitant Azole Antifungal Therapy | 20 Days | Standard Deviation 1.4 |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Median Time to CR/CRi | 1.7 Months |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles | 0 Cycle Interrupted | 20 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles | 1 Cycle Interrupted | 7 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Interrupted Inotuzumab Ozogamicin Treatment Cycles | 2 Cycle Interrupted | 1 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles | Received Total of 1 Cycle | 6 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles | Received Total of 2 Cycles | 13 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles | Received Total of 3 Cycles | 5 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles | Received Total of 4 Cycles | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles | Received Total of 5 Cycles | 0 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Number of Inotuzumab Ozogamicin Treatment Cycles | Received Total of 6 Cycles | 2 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 1: 0.8 milligram per meter square (mg/m^2) | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 1: 1.8 mg/m^2 | 27 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 2: 1.0 mg/m2 | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 2: 1.2 mg/m^2 | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 2: 1.5 mg/m^2 | 9 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 2: 1.8 mg/m^2 | 11 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 3: 1.5 mg/m^2 | 4 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 3: 1.8 mg/m^2 | 5 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 4: 0.5 mg/m^2 | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 4: 1.5 mg/m^2 | 3 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 5: 1.5 mg/m^2 | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Prescribed Inotuzumab Ozogamicin Doses | Cycle 6: 1.5 mg/m^2 | 2 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 1: Cycle was not Interrupted | 24 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle1: Interrupted Due to Death | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 1:Interrupted Due to Liver toxicity Treatment Related Adverse Events (TRAEs) | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 1: Interrupted Due to Neutropenia and Severe Constipation | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 1: Interrupted Due to SARS-CoV 2 infection | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 2: Cycle was not Interrupted | 19 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 2: Interrupted Due to High Fever, Rigors, Vomiting, Hypotension | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 2: Interrupted Due to Liver Toxicity TRAE(s) | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 2: Interrupted Due to Nausea, Poor oral intake, Neutropenic Sepsis | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 3: Cycle was not Interrupted | 7 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 3: Interrupted Due to Infection in Peripherally Inserted Central Catheter | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Reasons for Inotuzumab Ozogamicin Treatment Interruption | Cycle 3: Interrupted Due to Transferred to Another Hospital | 1 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | Spironolactone | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Type of Treatments Received for Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | Ursodeoxycholic Acid | 1 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment | Chemotherapy | 16 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment | HSCT | 9 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Types of Therapies Post Inotuzumab Ozogamicin Treatment | CAR-T cell therapy | 8 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation | Antibiotics/ Intensive Therapy Unit | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants According to Types of Treatments Received for Grade3/4 TRAE Following Inotuzumab Ozogamicin Initiation | High dose septrin + Caspofungi | 1 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified According to Their Cause of Death | Acute Lymphoblastic Leukaemia | 15 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified According to Their Cause of Death | Pneumonia | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified According to Their Cause of Death | SAR COV 2 | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified According to Their Cause of Death | Subarachnoid/Intraparenchymal Hemorrhage Stroke | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified According to Their Cause of Death | Veno-Occlusive Disease | 1 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 4 | No data recorded | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 5 | Participants with no dose modification | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 5 | No data recorded | 0 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 1 | Participants with no dose modification | 26 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 1 | No data recorded | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 2 | Participants with no dose modification | 20 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 2 | No data recorded | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 3 | Participants with no dose modification | 7 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 3 | No data recorded | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 4 | Participants with no dose modification | 3 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 6 | Participants with no dose modification | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Classified on the Basis of Any Modifications in Inotuzumab Ozogamicin Dose | Cycle 6 | No data recorded | 0 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Complete Remission (CR) by the End of InO Treatment | 15 Participants |
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%.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Blinatumomab: SD | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | HSCT: CR | 5 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | HSCT: CRi | 3 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | HSCT: Not Known | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | CAR-T cell therapy: CR | 5 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | CAR-T cell therapy: CRi | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | CAR-T cell therapy: PD | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | CAR-T cell therapy: Not Known | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Blinatumomab: CR | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Blinatumomab: Not Recorded | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Blinatumomab: PD | 3 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Other Chemotherapy: CR | 3 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Other Chemotherapy: CRi | 4 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Other Chemotherapy: Missing | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Other Chemotherapy: Not Recorded | 11 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Other Chemotherapy: PD | 4 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR, CRi, Progressive Disease and Stable Disease With Different Types of Post Inotuzumab Ozogamicin Treatments | Other Chemotherapy: SD | 1 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR With Incomplete Hematological Recovery (CRi) by the End of InO Treatment | 5 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Negative Minimal Residual Disease (MRD) Among Those Who Had CR/CRi | 14 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Negative MRD Classified Per InO Cycles | 1 | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Negative MRD Classified Per InO Cycles | 2 | 7 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Negative MRD Classified Per InO Cycles | 3 and above | 6 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment | Participants With VOD/SOS | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Experienced a Documented Diagnosis of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Post InO Treatment | Participants Not With VOD/SOS | 26 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation | Grade 3 | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Experienced Grade 3 and Grade 4 (Lung/Cardiac/Kidney/Liver) Treatment Related Adverse Event (TRAE) Following Inotuzumab Ozogamicin Initiation | Grade 4 | 1 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation | 3 months | 25 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation | 6 months | 19 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Survived at 3, 6 and 12 Months Post InO Treatment Initiation | 12 months | 13 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Survived Following Treatment For Documented Diagnoses of Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) | 1 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Survived Post InO Blinatumomab Treatment | 8 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy | Not Treated With Concomitant Azole Antifungal Therapy | 26 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Were Treated With Concomitant Azole Antifungal Therapy | Treated With Concomitant Azole Antifungal Therapy | 2 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With CR/CRi by the End of InO Treatment | 20 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With Interrupted InO Treatment Due to VOD/SOS | 2 Participants |
Secondary
Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With Liver Dysfunction Following Inotuzumab Ozogamicin Initiation | 1 Participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With Moderate Severity VOD/SOS | 2 Participants |
Secondary
Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT
Time frame: 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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With Peripheral Blood Blast Counts Measurement Prior to Post InO HSCT | 0 Participants |
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
Time frame: 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
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Number of alkylating agents:1 | Experienced VOD/SOS: Yes | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Number of alkylating agents:1 | Experienced VOD/SOS: No | 7 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Number of alkylating agents: 3 | Experienced VOD/SOS: Yes | 0 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Number of alkylating agents: 3 | Experienced VOD/SOS: No | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Busulfan-containing regimen | Experienced VOD/SOS: Yes | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Busulfan-containing regimen | Experienced VOD/SOS: No | 8 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last bilirubin concentration prior to follow-up HSCT: > upper limit normal (ULN) | Experienced VOD/SOS: Yes | 0 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last bilirubin concentration prior to follow-up HSCT: > upper limit normal (ULN) | Experienced VOD/SOS: No | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last bilirubin concentration prior to follow-up HSCT: <ULN | Experienced VOD/SOS: Yes | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last bilirubin concentration prior to follow-up HSCT: <ULN | Experienced VOD/SOS: No | 6 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last bilirubin concentration prior to follow-up HSCT: Missing | Experienced VOD/SOS: Yes | 0 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last bilirubin concentration prior to follow-up HSCT: Missing | Experienced VOD/SOS: No | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Age: <55 years | Experienced VOD/SOS: Yes | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Age: <55 years | Experienced VOD/SOS: No | 7 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Age: >55 years | Experienced VOD/SOS: Yes | 0 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Age: >55 years | Experienced VOD/SOS: No | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last ALT concentration prior to follow-up HSCT: less than or equal to (≤)1.5 ULN | Experienced VOD/SOS: Yes | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last ALT concentration prior to follow-up HSCT: less than or equal to (≤)1.5 ULN | Experienced VOD/SOS: No | 7 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last ALT concentration prior to follow-up HSCT: Missing | Experienced VOD/SOS: Yes | 0 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last ALT concentration prior to follow-up HSCT: Missing | Experienced VOD/SOS: No | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last AST concentration prior to follow-up HSCT: ≤1.5 ULN | Experienced VOD/SOS: Yes | 0 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last AST concentration prior to follow-up HSCT: ≤1.5 ULN | Experienced VOD/SOS: No | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last AST concentration prior to follow-up HSCT: Missing | Experienced VOD/SOS: Yes | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With Significant Risk Factors for VOD/SOS | Last AST concentration prior to follow-up HSCT: Missing | Experienced VOD/SOS: No | 7 Participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Overall Survival (OS) | 11.7 Months |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation | 3 months | 82.1 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation | 6 months | 60.7 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Percentage of Participants Who Were Relapse-free at 3, 6 and 12 Months Post InO Treatment Initiation | 12 months | 39.3 Percentage of participants |
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.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Relapse-free Survival (RFS) | 8.86 Months |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Time to Non-relapse Mortality (NRM) | 12.69 Months |
Secondary
Total Duration of Treatment With Inotuzumab Ozogamicin
In this outcome measure, total duration of InO treatment was reported.
Time frame: 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
Population: FAS included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Total Duration of Treatment With Inotuzumab Ozogamicin | 71.4 Days | Standard Deviation 52.4 |