Latin American Real-world Study in Acute Leukemia

Completed

• Conditions: Acute Lymphoid Leukemia; Acute Myeloid Leukemia

• Registration Number: NCT05166135
• Lead Sponsor: Pfizer

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-12-07
• Study Start: 2021-12-10
• Study First Posted: 2021-12-21
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 589

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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

Name	Time	Method
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.
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.
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).

Trial Locations

Locations (14)

FUNDALEU - Fundacion para combatir la Leucemia; 🇦🇷 Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Hospital São Rafael; 🇧🇷 Salvador, Bahia, Brazil

Hospital Privado Centro Medico de Cordoba S.A.; 🇦🇷 Cordoba, Argentina

Sanatorio Allende; 🇦🇷 Cordoba, Argentina

Fundação Doutor Amaral Carvalho; 🇧🇷 Jaú, SAO Paulo / Brazil, Brazil

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira; 🇧🇷 São Paulo, Brazil

Hospital Beneficência Portuguesa de São Paulo; 🇧🇷 São Paulo, Brazil

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil

Hospital Guillermo Grant Benavente; 🇨🇱 Concepcion, Chile

Fundacion Santa Fe de Bogota; 🇨🇴 Bogotá, Colombia

Oncomedica SA; 🇨🇴 Montería, Colombia

Hospital Italiano de la Plata; 🇦🇷 La Plata, Buenos Aires, Argentina

Hospital Universitario Austral; 🇦🇷 Pilar, Buenos Aires, Argentina

Instituto COI de Pesquisa; 🇧🇷 Rio de Janeiro, Brazil