Promyelocytic Leukemia, Acute Clinical Trial
— Mexico APLOfficial title:
Results From a Mexican Long-term Multicentric Study on Acute Promyelocytic Leukemia.
| Verified date | September 2020 |
| Source | Instituto Nacional de Cancerologia de Mexico |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Completed |
| Enrollment | 360 |
| Est. completion date | January 1, 2018 |
| Est. primary completion date | January 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Nidia Zapata | Mexico | Mexico City |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto Nacional de Cancerologia de Mexico |
Mexico,
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* Note: There are 17 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin) | Event free survival and overall survival with different anthracyclin | January 2007-January 2017 | |
| Secondary | Complications with different anthracycline | Complications | January 2007-January 2017 |