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Results From a Mexican Acute Promyelocytic Leukemia.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04562818
Acronym
Mexico APL
Enrollment
360
Registered
2020-09-24
Start date
2007-01-01
Completion date
2018-01-01
Last updated
2020-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Promyelocytic Leukemia, Acute

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.

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.

Interventions

DIAGNOSTIC_TESTDiagnosis

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

DIAGNOSTIC_TESTMolecular and Karyotype

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

DIAGNOSTIC_TESTLeucocytes

Sponsors

Instituto Nacional de Cancerologia de Mexico
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Overall survival in Mexico in patients with acute promyelocytic leukemiaJanuary 2007- January 2017Overall survival in different institutions in Mexico, in patient with diagnostic with acute promyelocytic leukemia

Secondary

MeasureTime frameDescription
Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin)January 2007-January 2017Event free survival and overall survival with different anthracyclin
Complications with different anthracyclineJanuary 2007-January 2017Complications

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026