Clinical Characteristics of Patients With Leukemia and COVID-19

Completed

• Conditions: Covid19; Leukemia, Lymphoblastic; Leukemia, Acute

• Registration Number: NCT04745416
• Lead Sponsor: Hospital General de Mexico

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-25
• Study First Submitted: 2021-01-29
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	through study completion, an average of 1 year
Number of relapses	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
Progression free survival	through study completion, an average of 1 year
Complete Remission	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	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

Trial Locations

Locations (2)

Hospital Regional de Alta Especialidad de Ixtapaluca; 🇲🇽 Ixtapaluca, State Of Mexico, Mexico

Hospital General de México "Dr. Eduardo Liceaga"; 🇲🇽 Mexico City, Mexico