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NCT04699162 Clinical Trial

Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia Clinical Trial

— HGMHRAEI/ALL  

Official title:
Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia. Experience of Two Centers in Mexico City

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04699162
Other study ID # DECS/JPO-CT-397-2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2016
Est. completion date December 31, 2020

Study information
Verified date January 2021
Source Hospital General de Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Description:

Retrospective, observational study in patients with diagnosis of acute lymphoblastic leukemia, according to the criteria of the World Health Organization, from July, 2016, to October, 2020. The patients were cared for in the hematology department of the Hospital General de Mexico and in the hematology department of the Hospital Regional de Alta Especialidad Ixtapaluca. Relapse was considered in those cases with more than 5% of blasts in bone marrow and as relapse to the central nervous system with the presence of blasts in cerebrospinal fluid.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date December 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 15 Years to 60 Years
Eligibility Inclusion Criteria: - Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization. Exclusion Criteria: - Age less than 15 years - Age over 60 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Mexico Hospital Regional de Alta Especialidad de Ixtapaluca Ixtapaluca State Of Mexico
Mexico Hospital General de México "Dr. Eduardo Liceaga" Mexico City

Sponsors (1)
Lead Sponsor Collaborator
Christian Omar Ramos-Peñafiel, MD, PhD

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival 4-years
Primary Progression free survival 4-years
Primary 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
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