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

Study Overview
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Brief Summary
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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.

Official Title
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A Retrospective Analysis of Inotuzumab Ozogamicin (InO) Usage in Adult Patients With Relapsed/Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (ALL)

Conditions
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Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: Inotuzumab Ozogamicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult relapsed or refractory B Cell ALL<br>Adult patients whose B Cell ALL has occurred again after the last treatment or patients who never responded to prior treatment | Drug: Inotuzumab Ozogamicin<br>* Inotuzumab Ozogamicin is an Antibody drug conjugate directed against CD 22 positive B Cell ALL<br>* Other names: Inonza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in 1st salvage |  | From last dose of InO; up to 6 months | 
| Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in 2nd salvage |  | From last dose of InO; up to 6 months | 
| Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in 3rd salvage |  | From last dose of InO; up to 6 months | 
| Percentage of participants who have achieved complete remission or complete remission with incomplete haematological recovery following treatment with InO in >3 lines of salvage |  | From last dose of InO; up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving Minimum Residual Disease (MRD) Negativity in participants achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) | MRD analysis performed in participants who achieved CR or CRi. Bone marrow aspirates, collected and sent to laboratory and analyzed using multiparametric flow cytometry | Up to approximately 6 months from last dose of InO | 
| Number of cycles of InO needed to attain CR/CRi determined by laboratory testing |  | Up to 6 months after the last dose of InO | 
| Duration of Remission (DoR) for participants who achieved CR/CRi (per investigator assessment). | DoR was defined as time from date of first response in responders (CR/CRi per investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). | Up to 6 months after the last dose of InO | 
| Number of participants categorized according to dose modifications |  | Up to 6 months after the last dose of InO | 
| Number of participants categorized according to number of cycles |  | Up to 6 months from last dose of InO | 
| Number of participants with concomitant medications |  | Upto 6 months after last dose of InO | 
| Hematopoietic stem cell transplantation (HSCT) rate was defined as the percentage of participants who underwent stem cell transplantation (SCT) following treatment with InO | Number of patients who proceed to transplant | Up to 6 months from last dose | 
| Overall survival (OS) in transplanted participants | OS is defined as the time from start of therapy to date of death due to any cause. | At 6 months and 1 year after the last dose of InO | 
| Overall survival (OS) in non transplanted participants | OS is defined as the time from start of therapy to date of death due to any cause. | At 6 months & 1 year after the last dose of InO | 
| Number of participants categorized according to cause of death |  | At 6 months & 1 year after the last dose of InO | 
| Relapse-free-survival in months determined by progression of disease and flowcytometric evaluation (all participants) |  | From last dose of InO; up to 6 months & 12 months | 
| Relapse free survival in months determined by progression of disease and flowcytometric evaluation (participants with follow up HSCT) |  | Up to 6 months & 1 year after last dose of InO | 
| Relapse free survival in months determined by progression of disease and flowcytometric evaluation (participants without follow up HSCT) |  | From last dose of InO; up to 6 months & 12 months | 
| Rate of Hepatic veno-occlusive disease (VOD) in transplanted participants determined by Liver function tests | VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules. | Up to 1 year from last dose of InO | 
| Rate of Hepatic veno-occlusive disease (VOD) in non-transplanted participants determined by Liver function tests | VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules. | Up to 1 year from last dose of InO | 
| Number of participants reporting Grade 3/4 treatment related Adverse Events following InO initiation | Grades 3 are severe and undesirable adverse events and grade 4 are life threatening or disabling adverse events | Up to 1 year from last dose of InO | 
| Percentage of participants who achieved complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) in extramedullary disease and Lymphoblastic Lymphoma (LBL) |  | Up to 1 year from last dose of InO | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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