Latin American Real-world Study in Acute Leukemia

Study Overview
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Brief Summary
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The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and de novo AML in 4 Latin American countries.

Detailed Description
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This is a retrospective multicenter non-interventional study using real-world data collected from medical records of newly diagnosed AML or with relapsed/refractory B-cell ALL diagnosed between 01 January 2015 and 31 December 2019 in 4 Latin American countries: Argentina, Brazil, Chile, and Colombia. In addition, as secondary objectives, the study will also describe molecular profile, cytogenetic risk, clinical outcomes, and healthcare resource utilization of treated B-cell ALL R/R and AML patients.

Official Title
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Real-world Study in Acute Leukemia: Epidemiology, Treatment Patterns and Outcomes for B-cell ALL and AML in Adult Patients From Latin America - LOYAL Study

Conditions
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Acute Myeloid Leukemia, Acute Lymphoid Leukemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years old at diagnosis Confirmed diagnosis of relapsed/refractory B-cell ALL or de novo AML diagnosed between 01 January 2015 and 31 December 2019 At least 1 line of treatment for R/R B-cell ALL or de novo AML within the study period Exclusion Criteria: Patients with no medical chart available Patients with unreliable data as per investigator's opinion (e.g. excessive missing data or inconsistence data) Patients that have participated in any interventional clinical trial for relapsed/refractory B-cell ALL or AML at any moment Patients with secondary AML Patients with any concomitant primary malignancy Patients with acute promyelocytic leukemia (APL)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Acute Myeloid Leukemia<br>Patients ≥18 years old at diagnosis, with de novo AML diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for AML within the study period. | |
| Relapsed/Refractory Acute Lymphoid Leukemia<br>Patients ≥18 years old at diagnosis, with R/R ALL diagnosed between 01 January 2015 and 31 December 2019, as documented in the medical chart and according to the physician's notes, and with at least 1 line of treatment for R/R ALL within the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Diagnosed with de novo AML or R/R B-cell | Bone marrow aspirate/biopsy results | 01 January 2015 and 31 December 2019 | 
| Sites of the Disease | Imaging exams results: computerized tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) scan | 01 January 2015 and 31 December 2019 | 
| Treatment Patterns | Treatment regimens used since diagnosis until loss of follow-up or death: front-line induction therapies, consolidation therapies, salvage therapies, conditioning therapy, hematological stem cell transplantation (autologous/allogeneic), intrathecal chemotherapy, palliative care | Baseline up to 7 years | 
| ECOG (Eastern Cooperative Oncology Group) Performance Status | Eastern Cooperative Oncology Group Performance Status (ECOG-PS) measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead | Baseline up to 7 years | 
| Cytogenetic profile | Evaluated by karyotyping, Fluorescent in situ hybridization (FISH) and/or Polymerase chain reaction (PCR) | Baseline up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival (EFS) | Time from treatment initiation to relapse, failure to achieve remission, resistant leukemia, second malignancy, or death of any cause, censored at the last valid disease assessment. | Baseline up to 7 years | 
| Response rate - complete response (CR) | No physical signs of leukemia, bone marrow with active hematopoiesis, <5% bone marrow blasts and more than 1 × 109/l granulocytes and more than 100 × 109/l platelets in the blood and no circulating leukemic blasts or evidence of extramedullary leukemia. | Baseline up to 7 years | 
| Response rate - complete response with incomplete blood count recovery (CRi) | Definition includes all CR criteria except for residual neutropenia (<1.0 × 109/L [1000/µL]) or thrombocytopenia (<100 × 109/L [100 000/µL]). | Baseline up to 7 years | 
| Response rate - partial remission (PR) | All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. | Baseline up to 7 years | 
| Overall Survival | Considered as death from any cause from the time of initiation of diagnosis or treatment. For participants who are alive, overall survival will be censored at the last contact. | Baseline up to 7 years | 
| Probability of Patient Survival in 1, 3- and 5-years follow up | Percentage of patients alive in 1, 3- and 5 years follow up since disease diagnosis or treatment initiation. | From start of disease diagnosis or treatment initiation through 1, 3- and 5 years follow-up | 
| Relapse Free Survival (RFS) | Interval between the date of remission until the date of relapse or death from any cause; patients not known to have relapsed or died at last follow-up are censored on the date they were last examined. Defined only for patients achieving CR, or CRi. | Baseline up to 7 years | 
| Healthcare Resource Utilization (HCRU) | Participants' utilization of healthcare resources evaluated as number of events for healthcare resources utilization including: inpatient admissions, hospitalization length of stay, surgical procedures, blood transfusions, concomitant medication (eg. prophylactic therapy for infections), and other conditions related to the AML/ALL treatment or disease). | Baseline up to 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LOYAL study, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Relapsed Refractory B-cell Acute Lymphoblastic Leukemia, Acute Leukemia in Latin America