Latin American Real-world Study in Acute Leukemia

NCT ID: NCT05166135

Last Updated: 2025-03-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

589 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-10

Study Completion Date

2022-11-15

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.

Conditions

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Acute Myeloid Leukemia Acute Lymphoid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

Site Status

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Site Status

FUNDALEU - Fundacion para combatir la Leucemia

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Site Status

Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, , Argentina

Site Status

Sanatorio Allende

Córdoba, , Argentina

Site Status

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Site Status

Fundação Doutor Amaral Carvalho

Jaú, SAO Paulo / Brazil, Brazil

Site Status

Instituto COI de Pesquisa

Rio de Janeiro, , Brazil

Site Status

ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

São Paulo, , Brazil

Site Status

Hospital Beneficência Portuguesa de São Paulo

São Paulo, , Brazil

Site Status

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Site Status

Hospital Guillermo Grant Benavente

Concepción, , Chile

Site Status

Fundacion Santa Fe de Bogota

Bogotá, , Colombia

Site Status

Oncomedica SA

Montería, , Colombia

Site Status

Countries

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Argentina Brazil Chile Colombia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=X9001302

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

Other Identifiers

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LOYAL

Identifier Type: OTHER

Identifier Source: secondary_id

X9001302

Identifier Type: -

Identifier Source: org_study_id

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