Results From a Mexican Acute Promyelocytic Leukemia.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Promyelocytic Leukemia, Acute

Intervention / Treatment
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* Diagnostic Test: Diagnosis
* Diagnostic Test: Molecular and Karyotype
* Diagnostic Test: Leucocytes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Daunorrubicin<br>Patient treated with daunorrubicin | Diagnostic Test: Diagnosis<br>* Determine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17)<br>Diagnostic Test: Molecular and Karyotype<br>* To realize the need of having more center we the technology to perform all of these tests<br>* Other names: PCR;Diagnostic Test: Leucocytes<br> <br> * Other names: Risk status;|
| Idarrubicin<br>Patient treated with idarrubicin | Diagnostic Test: Diagnosis<br>* Determine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17)<br>Diagnostic Test: Molecular and Karyotype<br>* To realize the need of having more center we the technology to perform all of these tests<br>* Other names: PCR;Diagnostic Test: Leucocytes<br> <br> * Other names: Risk status;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | January 2007- January 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin) | Event free survival and overall survival with different anthracyclin | January 2007-January 2017 | 
| Complications with different anthracycline | Complications | January 2007-January 2017 |