Clinical Characteristics of Patients With Leukemia and COVID-19

Covid19 Clinical Trial

Official 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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745416
• Other study ID #: DECS/JPO-CT-400-2020
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: February 2021
• Source: Hospital General de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 25, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Leukemia
• Leukemia, Acute
• Leukemia, Lymphoblastic
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Mexico	Hospital Regional de Alta Especialidad de Ixtapaluca	Ixtapaluca	State Of Mexico
Mexico	Hospital General de México "Dr. Eduardo Liceaga"	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		through study completion, an average of 1 year
Primary	Progression free survival		through study completion, an average of 1 year
Primary	Number of relapses	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
Primary	Complete Remission	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
Primary	COVID-19 confirmed	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)