Clinical trial NCT04562818: Results From a Mexican Acute Promyelocytic Leukemia.
Official title: Results From a Mexican Long-term Multicentric Study on Acute Promyelocytic Leukemia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Promyelocytic Leukemia, Acute
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 360
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient older 15 years old with acute promyelocytic Leukemia treated at a Mecican Center

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.

Eligibility 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

Primary outcomes:
measure: Overall survival in Mexico in patients with acute promyelocytic leukemia
timeFrame: January 2007- January 2017
Secondary outcomes:
measure: Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin)
timeFrame: January 2007-January 2017
measure: Complications with different anthracycline
timeFrame: January 2007-January 2017
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Nidia Zapata
state: Mexico City
Study officials:
References:
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