Results From a Mexican Long-term Multicentric Study on Acute Promyelocytic Leukemia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Overall survival in Mexico in patients with acute promyelocytic leukemia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Actute Promyelocytic leukemia PML/RAR alfa + Diabetes mellitus Hypertension Asthma Chronic renal disease
排除标准
- •Non Acute Promyelocytic leukemia Younger than 15 years old
结局指标
主要结局
Overall survival in Mexico in patients with acute promyelocytic leukemia
时间窗: January 2007- January 2017
Overall survival in different institutions in Mexico, in patient with diagnostic with acute promyelocytic leukemia
次要结局
- Difference in survival with different anthracycline (Daunorrubicin vs idarrubicin)(January 2007-January 2017)
- Complications with different anthracycline(January 2007-January 2017)
研究者
Nidia Paulina Zapata-Canto
Assistant Professor of Hematology Department (Acute Myeloid Leukemia)
Instituto Nacional de Cancerologia de Mexico