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CompletedNCT04745416Updated Feb 9, 2021

Clinical Characteristics of Patients With Leukemia and COVID-19

An observational study in Leukemia, Acute, Covid19 and Leukemia, Lymphoblastic, sponsored by Hospital General de Mexico. Completed at 2 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by Hospital General de Mexico · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Leukemia, Acute
  • Covid19
  • Leukemia, Lymphoblastic
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 30 is below the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Hospital General de Mexico is the lead sponsor of 26 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with first diagnosis of acute lymphoblastic leukemia

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age less than 18 years
  • Incomplete medical records
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Overall survival

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

  2. Progression free survival

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

  3. 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

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

  4. 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

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

  5. COVID-19 confirmed

    Reactive SARS-CoV-2 RT-PCR test

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

07

Study locations

2 sites
  • Hospital Regional de Alta Especialidad de Ixtapaluca
    Ixtapaluca, State Of Mexico 56530, Mexico
  • Hospital General de México "Dr. Eduardo Liceaga"
    Mexico City, 06720, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04745416
Lead sponsor
Hospital General de Mexico
Responsible party
Christian Omar Ramos-Peñafiel, MD, PhD (Head of the hematology hospitalization area, Hospital General de Mexico) — Principal investigator
First posted
Feb 9, 2021
Start date
Jan 1, 2020
Primary completion
Dec 31, 2020
Completion
Jan 25, 2021
Last update
Feb 9, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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