Latin American Real-world Study in Acute Leukemia

Acute Myeloid Leukemia Clinical Trial

— LOYAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166135
• Other study ID #: X9001302
• Secondary ID: LOYAL
• Status: Completed
• Start date: December 10, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Argentina	FUNDALEU - Fundacion para combatir la Leucemia	Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Hospital Privado Centro Medico de Cordoba S.A.	Cordoba
Argentina	Sanatorio Allende	Cordoba
Argentina	Hospital Italiano de la Plata	La Plata	Buenos Aires
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Brazil	Fundação Doutor Amaral Carvalho	Jaú	SAO Paulo / Brazil
Brazil	Instituto COI de Pesquisa	Rio de Janeiro
Brazil	Hospital São Rafael	Salvador	Bahia
Brazil	Hospital Beneficência Portuguesa de São Paulo	São Paulo
Brazil	Hospital Israelita Albert Einstein	São Paulo
Brazil	ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira	São Paulo
Chile	Hospital Guillermo Grant Benavente	Concepcion
Colombia	Fundacion Santa Fe de Bogota	Bogotá
Colombia	Oncomedica SA	Montería

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cytogenetic profile	Evaluated by karyotyping, Fluorescent in situ hybridization (FISH) and/or Polymerase chain reaction (PCR)	Baseline up to 7 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   To obtain contact information for a study center near you, click here.