InO - A Retrospective Study of UK Patients With Leukaemia

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.

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.

In this outcome measure, number of participants, who were treated with hematopoietic stem cell transplant (HSCT) before initiation of InO, were reported.

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.

In this outcome measure, number of participants who were previously treated with blinatumomab, were reported.

In this outcome measure, number of participants treated with chimeric antigen receptor (CAR) T-cell therapies before initiation of InO, were reported.

In this outcome measure, total duration of InO treatment was reported.

In this outcome measure, number of participants were classified according to total number of InO treatment cycles received.

In this outcome measure, number of participants were classified according to number of interrupted cycles of InO treatment.

In this outcome measure, number of participants, were reported according to reasons of interruption in respective Cycles.

In this outcome measure, number of participants according to prescribed starting InO dose, were reported.

In this outcome measure, number of participants were classified as following: 1) with no dose modification and 2) no data recorded.

In this outcome measure, number of participants who were treated with concomitant azole antifungal therapy along with InO treatment were reported.

In this outcome measure, time/duration between start date and end date of concomitant azole antifungal, was reported.

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.

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.

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.

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.

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.

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.

In this outcome measure, number of participants who survived 3, 6, and 12 post InO treatment, were reported.

In this outcome measure, number of participants according to their cause of death were reported.

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.

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.

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.

NRM was defined as the time from the date of follow-up HSCT until death due to any cause without disease progression or relapse.

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.

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%.

In this outcome measure, number of participants who survived at completion of InO treatment were reported.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

VOD, also called SOS, happens when the small blood vessels that lead into the liver and are inside the liver become blocked.

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.

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.

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