Clinical Characteristics of Patients With Leukemia and COVID-19

February 8, 2021 updated by: Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico

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"

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 06720
        • Hospital General de México "Dr. Eduardo Liceaga"
    • State Of Mexico
      • Ixtapaluca, State Of Mexico, Mexico, 56530
        • Hospital Regional de Alta Especialidad de Ixtapaluca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with first diagnosis of acute lymphoblastic leukemia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Leukemia and COVID-19
Patients diagnosed with acute lymphoblastic leukemia according to the criteria of the World Health Organization and confirmed diagnosis of COVID-19 by RT-PCR test
Leukemia
Patients diagnosed with acute lymphoblastic leukemia according to the criteria of the World Health Organization without suspicion of COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Progression free survival
Time Frame: through study completion, an average of 1 year
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
through study completion, an average of 1 year
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
through study completion, an average of 1 year
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
From the date of leukemia diagnosis to the end of the induction chemotherapy cycle 1 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

January 25, 2021

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DECS/JPO-CT-400-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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