Impact of a Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL) by Maintaining a Database

Leukemia, Promyelocytic, Acute Clinical Trial

Official title:

Assessing the Impact of a Simplified Patient Care Strategy to Decrease Early Deaths In Acute Promyelocytic Leukemia (APL) By Maintaining A Database

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02309333
• Other study ID #: IRB00067432
• Secondary ID: WINSHIP2488-13
• Status: Terminated
• Start date: November 2014
• Est. completion date: September 2018

Study information

• Verified date: December 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: September 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of APL

• Positive t (15:17) by fluorescence in situ hybridization (FISH)

• Promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha by polymerase chain reaction (PCR)

Exclusion Criteria:

• Only patients who refuse to provide consent will be excluded from the study

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Promyelocytic, Acute

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Gibbs Cancer Center and Research Institute	Spartanburg	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality in the first month after diagnosis		1 month after diagnosis
Secondary	Overall survival 18 months after accrual is completed		18 months after accrual completion
Secondary	Severity and duration of coagulopathy	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	5 years from start of trial
Secondary	Mortality with the severity and duration of coagulopathy	Correlation of mortality with the severity and duration of coagulopathy	5 years from start of trial
Secondary	Bleeding and infections and length of stay in hospital	Correlation of bleeding and infections and length of stay in hospital	5 years from start of trial
Secondary	Differentiation syndrome and length of hospital stay	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	5 years from start of trial
Secondary	Safety by grade 3 or 4 toxicity	Assessment of safety by grade 3 or 4 toxicity	5 years from start of trial
Secondary	Time to initiation of treatment from diagnosis	Correlation of outcomes with time to initiation of treatment from diagnosis	5 years from start of trial
Secondary	Outcomes across different treatment centers	Comparison of outcomes across different treatment centers.	5 years from start of trial