Impact of a Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL) by Maintaining a Database
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|ClinicalTrials.gov Identifier: NCT02309333|
Recruitment Status : Terminated (Previous principal investigators left institution)
First Posted : December 5, 2014
Last Update Posted : December 10, 2018
Acute promyelocytic leukemia (APL) is a very rare type of leukemia. Because it is so rare, many doctors do not have experience treating it. APL has been shown to be curable most of the time. Unfortunately, some patients die early after they become sick with APL, sometimes even before starting treatment. The early period is from the time of diagnosis through the first treatments for the disease. This is approximately 30 days. Early deaths are often due to complications caused by of the effects of leukemia and the treatments of it. These complications may not be noticed quickly by doctors who don't have much experience with managing APL.
The purpose of this study is to collect information about the diagnosis and management of APL patients by review of their medical records. This information will be stored in a central database at Emory University. This data will be analyzed to discover the impact of increased physician knowledge of recommended management of APL. The goal is to reduce the events of early death of APL patients.
|Condition or disease|
|Leukemia, Promyelocytic, Acute|
The investigators propose to collect data on patients with APL treated predominantly across the states of Georgia and South Carolina but will also extend it to cover patients from neighboring states. The treatment will be as per the treating physician and would be standard of care and no new drugs or changes to standard of care are being proposed in educating the treating physicians.
This is a multi-center study. At the lead sites, patients will sign the consent form and data will be collected at those respective sites. The sites outside of Emory are centers in the catchment area that treat leukemia. The lead investigators are available around the clock to co-manage the APL patients.
The objective of the study is to collect data to assess for improvement in mortality at the primary centers as well as at the local treatment centers. This change in mortality would depend on educating the community physicians and nursing staff and requires regular visits both by the physicians and the nurse coordinator. The community hematologists/oncologists in the catchment area will be educated by sending emails from investigators at 3 month intervals to inform them of the high early death rate associated with APL. In addition, a brief pamphlet will be mailed to them once every 3 months as a reminder. The lead investigators in each state will make presentations in regional meetings, visit practices, and also call local practices. In addition, a nurse coordinator will be instrumental in calling upon nursing staff in outlying hospitals in the catchment area to apprise them of early deaths in APL and also make them aware of the study and resources available. This will be done aggressively during the first 6 months prior to initiating the trial and will be continued during the three-year study period.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||117 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Assessing the Impact of a Simplified Patient Care Strategy to Decrease Early Deaths In Acute Promyelocytic Leukemia (APL) By Maintaining A Database|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||September 2018|
- Mortality in the first month after diagnosis [ Time Frame: 1 month after diagnosis ]
- Overall survival 18 months after accrual is completed [ Time Frame: 18 months after accrual completion ]
- Severity and duration of coagulopathy [ Time Frame: 5 years from start of trial ]Assessment of the severity and duration of coagulopathy, including presence or absence of clinically evident bleeding or bruising, and laboratory data including prothrombin time, activated partial thromboplastin time, international normalized ratio (INR), D-dimer, and fibrinogen
- Mortality with the severity and duration of coagulopathy [ Time Frame: 5 years from start of trial ]Correlation of mortality with the severity and duration of coagulopathy
- Bleeding and infections and length of stay in hospital [ Time Frame: 5 years from start of trial ]Correlation of bleeding and infections and length of stay in hospital
- Differentiation syndrome and length of hospital stay [ Time Frame: 5 years from start of trial ]Correlation of differentiation syndrome (dyspnea, unexplained fever, weight gain, peripheral edema, unexplained hypotension, acute renal failure [ARF], congestive heart failure [CHF], pleuropericardial effusions and interstitial pulmonary infiltrates) and length of hospital stay
- Safety by grade 3 or 4 toxicity [ Time Frame: 5 years from start of trial ]Assessment of safety by grade 3 or 4 toxicity
- Time to initiation of treatment from diagnosis [ Time Frame: 5 years from start of trial ]Correlation of outcomes with time to initiation of treatment from diagnosis
- Outcomes across different treatment centers [ Time Frame: 5 years from start of trial ]Comparison of outcomes across different treatment centers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309333
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Atlanta, Georgia, United States, 30342|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Gibbs Cancer Center and Research Institute|
|Spartanburg, South Carolina, United States, 29303|
|Principal Investigator:||Martha Arellano, MD||Emory University|