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.
Study Type
OBSERVATIONAL
Enrollment
28
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.
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
University College London Hospital NHS Foundation Trust
London, United Kingdom
The Royal Marsden NHS Foundation Trust of Fulham Road
London, United Kingdom
Taunton and Somerset NHS Foundation Trust of Musgrove Park Hospital
Taunton, United Kingdom
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
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
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
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
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Number of Participants Who Were Treated Previously With Blinatumomab
In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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