An observational study in Promyelocytic Leukemia, Acute, sponsored by Instituto Nacional de Cancerologia de Mexico. Completed at 1 site in Mexico. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-24.
Sponsored by Instituto Nacional de Cancerologia de Mexico · Observational
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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 360 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Instituto Nacional de Cancerologia de Mexico is the lead sponsor of 41 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patient older 15 years old with acute promyelocytic Leukemia treated at a Mecican Center
Exclusion Criteria:
Patient treated with daunorrubicin
Diagnostic Test: Diagnosis · Diagnostic Test: Molecular and Karyotype · Diagnostic Test: Leucocytes
Patient treated with idarrubicin
Diagnostic Test: Diagnosis · Diagnostic Test: Molecular and Karyotype · Diagnostic Test: Leucocytes
Determine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17)
To realize the need of having more center we the technology to perform all of these tests
Also known as: FISH, Karyotype, PCR
Also known as: Risk status
Overall survival in Mexico in patients with acute promyelocytic leukemia
Overall survival in different institutions in Mexico, in patient with diagnostic with acute promyelocytic leukemia
Time frame: January 2007- January 2017
Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin)
Event free survival and overall survival with different anthracyclin
Time frame: January 2007-January 2017
Complications with different anthracycline
Complications
Time frame: January 2007-January 2017
Plan to share: No — 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
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Cancerologia de Mexico