NCT04699162

Brief Summary

The aim of this study is to describe the survival and relapses of patients with diagnosis of acute lymphoblastic leukemia at two tertiary level hospitals in the metropolitan area of the valley of Mexico

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

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

July 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

4.3 years

First QC Date

January 5, 2021

Last Update Submit

January 12, 2021

Conditions

Acute Lymphoblastic Leukemia

Keywords

SurvivalLeukemiaRelapseRetrospective study

Outcome Measures

Primary Outcomes (3)

  • Overall survival

    4-years

  • Progression free survival

    4-years

  • 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

    4-years

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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 15 years
  • Age over 60 years

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

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemiaRecurrence

Condition Hierarchy (Ancestors)

Leukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian O Ramos-Peñafiel, MD, Ph.D

    Hospital General de México Dr. Eduardo Liceaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the hematology hospitalization area

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

July 1, 2016

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Locations

ME(2)