Clinical Characteristics of Patients With Leukemia and COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Leukemia, Acute, Covid19, Leukemia, Lymphoblastic

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leukemia and COVID-19<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | through study completion, an average of 1 year | 
| Progression free survival |  | through study completion, an average of 1 year | 
| 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 | 
| 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 | 
| 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) |