A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment

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.

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.

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.

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.

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.

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.

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.

Remission was defined as either the reduction or disappearance of the signs and symptoms of leukemia for 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 for whom there was deviation in InO dose from the standard dose (1.8 mg/ m^2 per cycle) were included.

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.

HSCT is the transplantation of multipotent hematopoietic stem cells to treat some type of cancers and other diseases.

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 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.

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.

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.

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.

VOD occurs when the small blood vessels in the liver are blocked.

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.

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%.

VOD occurs when the small blood vessels in the liver are blocked.

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.

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.

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.