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Completed

NCT Number: NCT04562818

Results From a Mexican 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.

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Key information

Conditions

Promyelocytic Leukemia, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Neoplasms Neoplasms by Histologic Type

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nidia Zapata

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnosis

Diagnostic Test

Determine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17)

Molecular and Karyotype

Diagnostic Test

To realize the need of having more center we the technology to perform all of these tests

Other names: FISH, Karyotype, PCR

Leucocytes

Diagnostic Test

Other names: Risk status

Primary outcomes

  1. 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

Secondary outcomes

  1. Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin)

    Time frame: January 2007-January 2017

    Event free survival and overall survival with different anthracyclin

  2. Complications with different anthracycline

    Time frame: January 2007-January 2017

    Complications

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia de Mexico

Other

Registry information

Official study title

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

Acronym: Mexico APL

Important dates

Study start
2007
Primary completion
2017
Study completion
2018
First posted
Sep 24, 2020
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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