NCT04745416

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 29, 2021

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Hospital General de México "Dr. Eduardo Liceaga"

Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

LeukemiaCOVID-19Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

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

Locations