Clinical Characteristics of Patients With Leukemia and COVID-19
1 other identifier
observational
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2021
CompletedFirst Submitted
Initial submission to the registry
January 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 9, 2021
CompletedFebruary 9, 2021
February 1, 2021
1 year
January 29, 2021
February 8, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
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)
Study Arms (2)
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
Eligibility Criteria
Patients with first diagnosis of acute lymphoblastic leukemia
You may qualify if:
- Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization.
You may not qualify if:
- Age less than 18 years
- Incomplete medical records
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital Regional de Alta Especialidad de Ixtapaluca
Ixtapaluca, State of Mexico, 56530, Mexico
Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, 06720, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the hematology hospitalization area
Study Record Dates
First Submitted
January 29, 2021
First Posted
February 9, 2021
Study Start
January 1, 2020
Primary Completion
December 31, 2020
Study Completion
January 25, 2021
Last Updated
February 9, 2021
Record last verified: 2021-02