Clinical Characteristics of Patients With Leukemia and COVID-19

The purpose of this study is to describe the main clinical characteristics of patients with de novo acute lymphoblastic leukemia treated inside the third level hospitals converted to Coronavirus disease 2019 (COVID-19) attention for the metropolitan area of Mexico City.

Completed

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Key information

Conditions

Leukemia, Acute COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoblastic Leukemia, Lymphoid Lung Diseases Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nidovirales Infections Pneumonia Pneumonia, Viral Precursor Cell Lymphoblastic Leukemia-Lymphoma RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional de Alta Especialidad de Ixtapaluca, Ixtapaluca, State of Mexico, Mexico

About this study

Retrospective, observational study in patients with diagnosis of acute lymphoblastic leukemia, according to the criteria of the World Health Organization, from April 2020 to December 2020. Patients was cared for in the hematology department of the Hospital Regional de Alta Especialidad de Ixtapaluca or the Hospital General de México. Both hospitals have been assigned as Coronavirus disease 2019 (COVID-19) hospitals, limiting the access, number of outpatient visits and chemotherapy protocols.

Real-time polymerase chain reaction (RT-PCR) test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was performed for patients with respiratory symptoms or history of contact with suspected / confirmed cases of COVID-19 Upon having a positive RT-PCR test, patients were transferred to a respiratory isolation unit to continue their recovery. Support treatment for COVID-19 was based on local considerations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization.

Exclusion criteria

Age less than 18 years
Incomplete medical records

Treatment and study plan

Primary outcomes

Overall survival

Time frame: through study completion, an average of 1 year
Progression free survival

Time frame: through study completion, an average of 1 year
Number of relapses

Time frame: through study completion, an average of 1 year

Cases with more than 5 percent of blasts in bone marrow and as relapse to the central nervous system with the presence of blasts in cerebrospinal fluid
Complete Remission

Time frame: through study completion, an average of 1 year

Bone marrow has less than 5 percent blast cells, blood cell counts are within the normal range, and there are no signs or symptoms of leukemia
COVID-19 confirmed

Time frame: From the date of leukemia diagnosis to the end of the induction chemotherapy cycle 1 (each cycle is 28 days)

Reactive SARS-CoV-2 RT-PCR test

Sponsors and collaborators

Lead sponsor

Hospital General de Mexico

Other Gov

Registry information

Official study title

Clinical Characteristics of Patients With Hematological Cancer Diagnosed and Severe Acute Respiratory Syndrome Coronavirus 2 Infection at the Hospital de Alta Especialidad de Ixtapaluca and the Hospital General de México "Dr. Eduardo Liceaga"

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Feb 9, 2021
Registry last updated: Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed