Results From a Mexican Acute Promyelocytic Leukemia. (Mexico APL)

September 18, 2020 updated by: Nidia Paulina Zapata-Canto, Instituto Nacional de Cancerologia de Mexico

Results From a Mexican Long-term Multicentric Study on Acute Promyelocytic Leukemia.

Retrospective, observational study, comparing treatments of acute promyelocytic leukemia in different centers in México.

There is no sufficient information about acute promyelocytic leukemia in America Latina, particularly in Mexico.

For these reason the investigators started a study adding all promyelocityc patients from the main Hospital in Mexico in order to put together a group of patient and analyze the response, overall survival and what are the characteristics of the population.

The investigators included 5 Hospital in Mexico City and states as Monterrey, Guadalajara, San Luis Potosi, Puebla, Veracruz, Yucatán, Oaxaca, Guanajuato, Estado de México.

Even do, the investigators didn´t have arsenic trioxide they are treating patients with standard chemotherapy. These paper will help to show the authorities that the cost of treating patient with standard chemotherapy is much more higher than ATO-ATRA. The investigators are now doing a cost benefit analysis so the investigators, can soon have ATO treatment as standard of care in Mexico for the treatment of acute promyelocytic leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multicentric, retrospective, descriptive, longitudinal study was carried out. Between January 2007 and January 2017, patients of both sexes and different ages, who were candidates for receiving intensive chemotherapy along with tretinoin were included in the study. The diagnosis for Acute Promyelocytic Leukemia was determined based on the following criteria: abnormal promyelocytes in the bone marrow and verification of the t(15;17) translocation by karyotype or using RT-PCR to determine the genetic lesion and define the type of PML/RARA isoform.

In Mexico the investigators still treating patients with anthracycline and cytarabine + transretinoic acid. These information will help the authorities to realize the importance of having arsenic trioxide as part of the treatment of these disease, knowing the amount of patient that the investigators have in Mexico, knowing that in the hispanic race the incidence is greater.

Study Type

Observational

Enrollment (Actual)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City
      • Mexico, Mexico City, Mexico, 14080
        • Nidia Zapata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patient older 15 years old with acute promyelocytic Leukemia treated at a Mecican Center

Description

Inclusion Criteria:

  • Actute Promyelocytic leukemia PML/RAR alfa + Diabetes mellitus Hypertension Asthma Chronic renal disease

Exclusion Criteria:

  • Non Acute Promyelocytic leukemia Younger than 15 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Daunorrubicin
Patient treated with daunorrubicin
Diagnostic test: Diagnosis
Determine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17)
Diagnostic test: Molecular and Karyotype
To realize the need of having more center we the technology to perform all of these tests
Other Names:
  • PCR
  • FISH
  • Karyotype
Diagnostic test: Leucocytes
Other Names:
  • Risk status
Idarrubicin
Patient treated with idarrubicin
Diagnostic test: Diagnosis
Determine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17)
Diagnostic test: Molecular and Karyotype
To realize the need of having more center we the technology to perform all of these tests
Other Names:
  • PCR
  • FISH
  • Karyotype
Diagnostic test: Leucocytes
Other Names:
  • Risk status

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival in Mexico in patients with acute promyelocytic leukemia
Time Frame: January 2007- January 2017
Overall survival in different institutions in Mexico, in patient with diagnostic with acute promyelocytic leukemia
January 2007- January 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin)
Time Frame: January 2007-January 2017
Event free survival and overall survival with different anthracyclin
January 2007-January 2017
Complications with different anthracycline
Time Frame: January 2007-January 2017
Complications
January 2007-January 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2007

Primary Completion (ACTUAL)

January 31, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (ACTUAL)

September 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCancerologiaMexico

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Plan is to published the information in Mexico, so we can start planing with the Mexican government the cost of treating a patient with Chemotherapy vs ATO/ATRA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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