Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia
Conditions
Keywords
Relapsed ALL, Refractory ALL, Adult Relapsed/Refractory ALL, Adult ALL, Relapsed B Cell ALL, Refractory B Cell ALL, Relapsed Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
Brief summary
The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment. This retrospective Study enroll adult patients who: * were CD22 positive (a molecule in the body that stops the over activity of the immune system) * Received only InO for the treatment of B-cell ALL that occurred again after the last treatment * were Philadelphia chromosome positive (which occurs because of changes in genes) * failed treatment with at least one Tyrosine Kinase Inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division). The patient data except their personal details are collected from a hospital based electronic medical record in India. In this study the effectiveness and safety of InO will be studied after it was released to the market. To do that, the study aims to gather details of B-cell ALL patients from 7 -10 hospitals across India: * in whom the disease occurred again * or those who never showed any improvement to earlier treatments * now being treated with InO alone Around 55 patients who have taken InO are likely to be enrolled in the study. Then by using a statistical model and with all the information gathered, the safety and effectiveness of InO will be decided.
Interventions
DRUGInotuzumab Ozogamicin
Inotuzumab Ozogamicin is an Antibody drug conjugate directed against CD 22 positive B Cell ALL
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 aged ≥18 years old at the initiation of InO treatment * Patients with relapsed/refractory B-cell ALL * Patients who initiated InO monotherapy between Feb'2017 and Feb'2022 and are CD22 positive * Ph+ patients who have failed treatment with at least 1 TKI
Exclusion criteria
* Patient not completing at least 1 cycle of InO therapy • Patient on InO in combination with chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. |
| Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. |
| Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9 cells/L and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of bone marrow blasts (BMB). In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years) | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. |
| Median Number of Cycles of InO Treatment | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | The median number of cycles of InO a participant received during treatment were included. Standard dose of InO: 1.8 mg/m\^2 per 21 days cycle. |
| Median Number of Cycles of InO Needed to Attain CR/CRi | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. |
| Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. |
| Duration of Remission (DOR) | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Remission was defined as either the reduction or disappearance of the signs and symptoms of leukemia for this study. |
| Number of Participants Categorized as Per InO Doses | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Standard dose of InO was 1.8 milligrams (mg) per meter square (m\^2) per cycle. Under dose of InO was less than 1.8 mg/m\^2 per cycle. Overdose of InO was more than 1.8 mg/m\^2 per cycle. |
| Number of Participants With InO Dose Modifications | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Number of participants for whom there was deviation in InO dose from the standard dose (1.8 mg/ m\^2 per cycle) were included. |
| Number of Participants Who Received Concomitant Medications | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Concomitant medication was defined as any medication other than, and in addition to, the study medication taken for any period of time during the treatment. |
| Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT) | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | HSCT is the transplantation of multipotent hematopoietic stem cells to treat some type of cancers and other diseases. |
| Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity | 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Survival rate: percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9 cells/L and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. In this outcome measure percentage of participants who had either CR or CRi with MRD negativity and survived at the end of 6 months and 12 months post initiation of InO treatment are reported on the basis of transplantation status. |
| Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on number of lines of salvage therapies. |
| Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolor flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. |
| Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years) | 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. In this outcome measure percentage of transplanted and non-transplanted participants greater than 65 years of age, who survived at the end of 6 months and 12 months post initiation of InO treatment are reported. |
| Number of Participants Categorized According to Cause of Death | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | — |
| Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | RFS was defined as time from index date to the earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), or the start of new induction therapy or posttherapy HSCT without achieving CR/CRi. Index date was defined as the date of initiation of the first cycle of InO. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Median duration of relapse free survival in all participants included those participants who had achieved CR/CRi is reported in this outcome measure. |
| Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | VOD occurs when the small blood vessels in the liver are blocked. |
| Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | VOD occurs when the small blood vessels in the liver are blocked. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. |
| Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | VOD occurs when the small blood vessels in the liver are blocked. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. |
| Percentage of Participants With VOD in Elderly Participants (>65 Years) | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | VOD occurs when the small blood vessels in the liver are blocked. |
| Number of Participants With Grade 3/4 Treatment Related Liver Toxicity (Hepatobiliary Disorder) Adverse Events (TEAEs) Following InO Initiation | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Treatment-related AE was any untoward medical occurrence in a participant who has received the study drug. Liver toxicity parameters included: Aspartate aminotransferase (level) \>=2.5\*upper limit of normal (ULN); alanine transaminase (level) \>=2.5\*ULN and total serum bilirubin \>=1.5\*ULN. Here, Grade 3 indicates severe events and Grade 4 indicates Life-threatening events where urgent intervention was required. |
| Number of Participants With Hematological Toxicities Following InO Initiation | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Hematological toxicities included: Febrile neutropenia= absolute neutrophil count (ANC) \< 1.0\*10\^9 cells/L, fever \>=38.5 degree C); Neutropenia= absolute granulocyte count \< 1.0\*10\^9 cells/L; Thrombocytopenia= platelet count \< 150,000 platelets per microliter. |
| Number of Participants With Extramedullary Disease (EMD) or Lymphoblastic Lymphoma (LBL) Who Achieved CR or CRi | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Extramedullary disease was the presence of leukemic cell aggregates in the form of solid tumor outside that of bone marrow. Lymphoblastic lymphoma, was a clonal hematopoietic stem cell disorder of B or T cell origin. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. |
| Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on high burden and low burden disease. |
| Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. Participants with either CR or CRi who achieved MRD negativity classified per number of lines of salvage therapies are reported in this outcome measure. |
| Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi | From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study) | Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. Participants with either CR or CRi who achieved MRD negativity classified per high burden and low burden disease are reported in this outcome measure. |
Countries
India
Participant flow
Recruitment details
Data of eligible Indian participants with Relapsed/Refractory/ B Cell Acute lymphoblastic leukemia (R/R B cell ALL), who aged greater than or equal to 18 years at the time of initiating treatment with Inotuzumab ozogamicin (InO) \[index date\], was collected retrospectively from hospital medical records. For eligibility Index date could have been between Feb 2017 to Feb 2022. Available data was retrieved from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months) in the current observational study.
Participants by arm
| Arm | Count |
|---|---|
| Inotuzumab Ozogamicin (InO) Participants who were treated with InO as a monotherapy and completed at least one cycle of InO and were CD22 positive, in real world setting under routine clinical practice outside of clinical trials were observed retrospectively. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Inotuzumab Ozogamicin (InO) | — |
|---|---|---|
| Age, Customized 18-50 years | 23 Participants | — |
| Age, Customized Above (>) 50 years | 9 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 21 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 17 / 32 |
| other Total, other adverse events | 28 / 32 |
| serious Total, serious adverse events | 19 / 32 |
Outcome results
Primary
Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO
CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO | 19 Participants |
Primary
Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation
CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation | Participants achieved CR/CRi during first salvage therapy | 6 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation | Participants achieved CR/CRi during second salvage therapy | 11 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation | Participants achieved CR/CRi during third salvage therapy | 2 Participants |
Primary
Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9 cells/L and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of bone marrow blasts (BMB). In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease | Participants achieved CR/CRi: BMB <50% | 10 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease | Participants achieved CR/CRi: BMB >=50% | 9 Participants |
Secondary
Duration of Remission (DOR)
Remission was defined as either the reduction or disappearance of the signs and symptoms of leukemia for this study.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Duration of Remission (DOR) | 6 Months |
Secondary
Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies | First Salvage Therapy | 2.33 Cycles of InO treatment | Standard Deviation 1.21 |
| Inotuzumab Ozogamicin (InO) | Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies | Second Salvage Therapy | 2.00 Cycles of InO treatment | Standard Deviation 1.48 |
| Inotuzumab Ozogamicin (InO) | Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies | Third Salvage Therapy | 3.50 Cycles of InO treatment | Standard Deviation 3.54 |
Secondary
Median Number of Cycles of InO Needed to Attain CR/CRi
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Median Number of Cycles of InO Needed to Attain CR/CRi | 2 Cycles of InO treatment |
Secondary
Median Number of Cycles of InO Treatment
The median number of cycles of InO a participant received during treatment were included. Standard dose of InO: 1.8 mg/m\^2 per 21 days cycle.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Median Number of Cycles of InO Treatment | 2 Cycles of InO Treatment |
Secondary
Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years)
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years) | 2 Participants |
Secondary
Number of Participants Categorized According to Cause of Death
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized According to Cause of Death | Progression of disease | 4 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized According to Cause of Death | Relapse | 6 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized According to Cause of Death | Septic Shock | 2 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized According to Cause of Death | Veno-occlusive disease (VOD)-related multiorgan failure | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized According to Cause of Death | VOD pneumonia | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized According to Cause of Death | Central nervous system (CNS) relapse | 1 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized According to Cause of Death | Not mentioned | 2 Participants |
Secondary
Number of Participants Categorized as Per InO Doses
Standard dose of InO was 1.8 milligrams (mg) per meter square (m\^2) per cycle. Under dose of InO was less than 1.8 mg/m\^2 per cycle. Overdose of InO was more than 1.8 mg/m\^2 per cycle.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized as Per InO Doses | Under Dose | 17 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized as Per InO Doses | Standard Dose | 12 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Categorized as Per InO Doses | Overdose | 3 Participants |
Secondary
Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino 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. MRD was assessed by multicolor flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi | Participants with CR who achieved MRD | 17 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi | Participants with CRi who achieved MRD | 1 Participants |
Secondary
Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. Participants with either CR or CRi who achieved MRD negativity classified per high burden and low burden disease are reported in this outcome measure.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi | BMB <50% | 10 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi | BMB >=50% | 8 Participants |
Secondary
Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi
Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. Participants with either CR or CRi who achieved MRD negativity classified per number of lines of salvage therapies are reported in this outcome measure.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi | First Salvage Therapy | 5 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi | Second Salvage Therapy | 11 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi | Third Salvage Therapy | 2 Participants |
Secondary
Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT)
HSCT is the transplantation of multipotent hematopoietic stem cells to treat some type of cancers and other diseases.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT) | 11 Participants |
Secondary
Number of Participants Who Received Concomitant Medications
Concomitant medication was defined as any medication other than, and in addition to, the study medication taken for any period of time during the treatment.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants Who Received Concomitant Medications | 0 Participants |
Secondary
Number of Participants With Extramedullary Disease (EMD) or Lymphoblastic Lymphoma (LBL) Who Achieved CR or CRi
Extramedullary disease was the presence of leukemic cell aggregates in the form of solid tumor outside that of bone marrow. Lymphoblastic lymphoma, was a clonal hematopoietic stem cell disorder of B or T cell origin. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With Extramedullary Disease (EMD) or Lymphoblastic Lymphoma (LBL) Who Achieved CR or CRi | 1 Participants |
Secondary
Number of Participants With Grade 3/4 Treatment Related Liver Toxicity (Hepatobiliary Disorder) Adverse Events (TEAEs) Following InO Initiation
Treatment-related AE was any untoward medical occurrence in a participant who has received the study drug. Liver toxicity parameters included: Aspartate aminotransferase (level) \>=2.5\*upper limit of normal (ULN); alanine transaminase (level) \>=2.5\*ULN and total serum bilirubin \>=1.5\*ULN. Here, Grade 3 indicates severe events and Grade 4 indicates Life-threatening events where urgent intervention was required.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With Grade 3/4 Treatment Related Liver Toxicity (Hepatobiliary Disorder) Adverse Events (TEAEs) Following InO Initiation | 12 Participants |
Secondary
Number of Participants With Hematological Toxicities Following InO Initiation
Hematological toxicities included: Febrile neutropenia= absolute neutrophil count (ANC) \< 1.0\*10\^9 cells/L, fever \>=38.5 degree C); Neutropenia= absolute granulocyte count \< 1.0\*10\^9 cells/L; Thrombocytopenia= platelet count \< 150,000 platelets per microliter.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With Hematological Toxicities Following InO Initiation | 28 Participants |
Secondary
Number of Participants With InO Dose Modifications
Number of participants for whom there was deviation in InO dose from the standard dose (1.8 mg/ m\^2 per cycle) were included.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Number of Participants With InO Dose Modifications | Below standard dose | 17 Participants |
| Inotuzumab Ozogamicin (InO) | Number of Participants With InO Dose Modifications | Above standard dose | 3 Participants |
Secondary
Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD
VOD occurs when the small blood vessels in the liver are blocked.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD | Transplanted Participants | 45.45 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD | Non-transplanted Participants | 10 Percentage of participants |
Secondary
Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease
VOD occurs when the small blood vessels in the liver are blocked. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease | BMB <50% | 18.75 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease | BMB >=50% | 25.00 Percentage of participants |
Secondary
Percentage of Participants With VOD in Elderly Participants (>65 Years)
VOD occurs when the small blood vessels in the liver are blocked.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inotuzumab Ozogamicin (InO) | Percentage of Participants With VOD in Elderly Participants (>65 Years) | 50.00 Percentage of participants |
Secondary
Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies
VOD occurs when the small blood vessels in the liver are blocked. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies | First Salvage Therapy | 20 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies | Second Salvage Therapy | 17 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies | Third Salvage Therapy | 50 Percentage of participants |
Secondary
Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT
RFS was defined as time from index date to the earliest date of the following events: death, progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), or the start of new induction therapy or posttherapy HSCT without achieving CR/CRi. Index date was defined as the date of initiation of the first cycle of InO. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9/L and absolute neutrophil count of \>1\*10\^9/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Median duration of relapse free survival in all participants included those participants who had achieved CR/CRi is reported in this outcome measure.
Time frame: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT | All Participants | 7 Months |
| Inotuzumab Ozogamicin (InO) | Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT | With Follow-up HSCT | 6 Months |
| Inotuzumab Ozogamicin (InO) | Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT | Without Follow-up HSCT | 9.5 Months |
Secondary
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years)
Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. In this outcome measure percentage of transplanted and non-transplanted participants greater than 65 years of age, who survived at the end of 6 months and 12 months post initiation of InO treatment are reported.
Time frame: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years) | Non-transplanted: >65 years: Survival rate at 6 Months | 50.0 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years) | Non-transplanted: >65 years: Survival rate at 12 Months | 50.0 Percentage of participants |
| Unknown | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years) | Transplanted: >65 years: Survival rate at 6 Months | — Percentage of participants |
| Unknown | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years) | Transplanted: >65 years: Survival rate at 12 Months | — Percentage of participants |
Secondary
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease
Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Disease burden was defined using percentage of BMB. In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on high burden and low burden disease.
Time frame: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | Transplanted: BMB <50%: Survival rate at 6 Months | 71.43 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | Transplanted: BMB >=50%: Survival rate at 6 Months | 50 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | Transplanted: BMB <50%: Survival rate at 12 Months | 42.86 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | Transplanted: BMB >=50%: Survival rate at 12 Months | 25 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | Non-transplanted: BMB <50%: Survival rate at 6 Months | 57.14 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | Non-transplanted: BMB >=50%: Survival rate at 6 Months | 33.33 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | Non-transplanted: BMB <50%: Survival rate at 12 Months | 28.57 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease | Non-transplanted: BMB >=50%: Survival rate at 12 Months | 25 Percentage of participants |
Secondary
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies
Survival rate was defined as the percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission. In this outcome measure percentage of transplanted and non-transplanted participants who survived at the end of 6 months and 12 months post initiation of InO treatment are classified based on number of lines of salvage therapies.
Time frame: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Non-transplanted participants: third salvage therapy: Survival rate at 12 months | 50 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Non-transplanted participants: first salvage therapy: Survival rate at 12 months | 33 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Non-transplanted participants: second salvage therapy: Survival rate at 12 months | 12.5 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Transplanted participants: second salvage therapy: Survival rate at 6 months | 66.7 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Transplanted participants: third salvage therapy: Survival rate at 6 months | 50 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Transplanted participants: second salvage therapy: Survival rate at 12 months | 33.3 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Transplanted participants: third salvage therapy: Survival rate at 12 months | 50 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Non-transplanted participants: first salvage therapy: Survival rate at 6 months | 56 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Non-transplanted participants: second salvage therapy: Survival rate at 6 months | 25.0 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Non-transplanted participants: third salvage therapy: Survival rate at 6 months | 50 Percentage of participants |
| Unknown | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Transplanted participants: first salvage therapy: Survival rate at 12 months | — Percentage of participants |
| Unknown | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies | Transplanted participants: first salvage therapy: Survival rate at 6 months | — Percentage of participants |
Secondary
Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity
Survival rate: percentage of participants in a study or treatment group who were still alive for a certain period of time after they were diagnosed with or started treatment for a disease. Negative MRD was defined as documented in medical records or (if unavailable in the records) as leukemic cells comprising \<1\*10\^-4 (\<0.01%) of bone marrow nucleated cells. MRD was assessed by multicolour flow cytometry. CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9 cells/L and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. In this outcome measure percentage of participants who had either CR or CRi with MRD negativity and survived at the end of 6 months and 12 months post initiation of InO treatment are reported on the basis of transplantation status.
Time frame: 6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity | Transplanted Participants: Survival rate at 6 Months | 66.7 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity | Non-transplanted Participants: Survival rate at 6 Months | 88.9 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity | Transplanted Participants: Survival rate at 12 Months | 33.3 Percentage of participants |
| Inotuzumab Ozogamicin (InO) | Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity | Non-transplanted Participants: Survival rate at 12 Months | 44.4 Percentage of participants |