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Mexico APL: Results From a Mexican Acute Promyelocytic Leukemia.

Sponsor
Instituto Nacional de Cancerologia de Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT04562818
Collaborator
(none)
360
Enrollment
1
Location
132
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Jan 1, 2007
Actual Primary Completion Date :
Jan 31, 2017
Actual Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm 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 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:
  • FISH
  • Karyotype
  • PCR

    • Diagnostic Test: Leucocytes
    Other Names:
  • Risk status

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival in Mexico in patients with acute promyelocytic leukemia [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) [January 2007-January 2017]

      Event free survival and overall survival with different anthracyclin

    2. Complications with different anthracycline [January 2007-January 2017]

      Complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Nidia Zapata Mexico Mexico City Mexico 14080

    Sponsors and Collaborators

    • Instituto Nacional de Cancerologia de Mexico

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Sep 24, 2020
    Last Update Posted:
    Sep 24, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Leukemia
    Leukemia, Promyelocytic, Acute

    Study Results

    No Results Posted as of Sep 24, 2020