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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04562818
Recruitment Status : Completed
First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nidia Paulina Zapata-Canto, Instituto Nacional de Cancerologia de Mexico

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment
Promyelocytic Leukemia, Acute Diagnostic Test: Diagnosis Diagnostic Test: Molecular and Karyotype Diagnostic Test: Leucocytes

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 Design
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Study Type : Observational
Actual Enrollment : 360 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Results From a Mexican Long-term Multicentric Study on Acute Promyelocytic Leukemia.
Actual Study Start Date : January 1, 2007
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Groups and Cohorts
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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:
  • FISH
  • Karyotype
  • PCR

Diagnostic Test: Leucocytes
Other Name: 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:
  • FISH
  • Karyotype
  • PCR

Diagnostic Test: Leucocytes
Other Name: Risk status


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patient older 15 years old with acute promyelocytic Leukemia treated at a Mecican Center
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562818


Locations
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Mexico
Nidia Zapata
Mexico, Mexico City, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
More Information
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Publications of Results:
Platzbecker U, Avvisati G, Cicconi L, Thiede C, Paoloni F, Vignetti M, Ferrara F, Divona M, Albano F, Efficace F, Fazi P, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Wattad M, Lübbert M, Brandts CH, Hänel M, Röllig C, Schmitz N, Link H, Frairia C, Pogliani EM, Fozza C, D'Arco AM, Di Renzo N, Cortelezzi A, Fabbiano F, Döhner K, Ganser A, Döhner H, Amadori S, Mandelli F, Ehninger G, Schlenk RF, Lo-Coco F. Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial. J Clin Oncol. 2017 Feb 20;35(6):605-612. doi: 10.1200/JCO.2016.67.1982. Epub 2016 Oct 31.

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Responsible Party: Nidia Paulina Zapata-Canto, Assistant Professor of Hematology Department (Acute Myeloid Leukemia), Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT04562818    
Other Study ID Numbers: INCancerologiaMexico
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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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
Additional relevant MeSH terms:
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Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
 Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid