LOYAL: Latin American Real-world Study in Acute Leukemia

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05166135

Collaborator

(none)

700

Enrollment

Location

16.6

Anticipated Duration (Months)

42.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Acute Lymphoid Leukemia

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

700 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 10, 2021

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Acute Myeloid Leukemia 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 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.

Outcome Measures

Primary Outcome Measures

Number of Participants Diagnosed with de novo AML or R/R B-cell [01 January 2015 and 31 December 2019]
Bone marrow aspirate/biopsy results
Sites of the Disease [01 January 2015 and 31 December 2019]
Imaging exams results: computerized tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) scan
Treatment Patterns [Baseline up to 7 years]
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
ECOG (Eastern Cooperative Oncology Group) Performance Status [Baseline up to 7 years]
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
Cytogenetic profile [Baseline up to 7 years]
Evaluated by karyotyping, Fluorescent in situ hybridization (FISH) and/or Polymerase chain reaction (PCR)

Secondary Outcome Measures

Event Free Survival (EFS) [Baseline up to 7 years]
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.
Response rate - complete response (CR) [Baseline up to 7 years]
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.
Response rate - complete response with incomplete blood count recovery (CRi) [Baseline up to 7 years]
Definition includes all CR criteria except for residual neutropenia (<1.0 × 109/L [1000/µL]) or thrombocytopenia (<100 × 109/L [100 000/µL]).
Response rate - partial remission (PR) [Baseline up to 7 years]
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%.
Overall Survival [Baseline up to 7 years]
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.
Probability of Patient Survival in 1, 3- and 5-years follow up [From start of disease diagnosis or treatment initiation through 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.
Relapse Free Survival (RFS) [Baseline up to 7 years]
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.
Healthcare Resource Utilization (HCRU) [Baseline up to 7 years]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)