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Leukemia, Promyelocytic, AcuteNCT02309333

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

An observational study of Leukemia, Promyelocytic, Acute, run by Emory University at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Leukemia, Promyelocytic, Acute
How many people
117 participants
Where
4 sitesUnited States
Study dates
Nov 2014to Sep 2018
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with APL treated predominantly across the states of Georgia and South Carolina, as well as from neighboring states.

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Gibbs Cancer Center and Research Institute

    Spartanburg, South Carolina, 29303

Other trials in United States

About this study

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

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.

Read the detailed 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.

Medical subject headings
Leukemia, Promyelocytic, Acute

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality in the first month after diagnosis

    Measured: 1 month after diagnosis

Secondary outcomes (8)

  1. Overall survival 18 months after accrual is completed

    Measured: 18 months after accrual completion

  2. 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

    Measured: 5 years from start of trial

  3. Mortality with the severity and duration of coagulopathy

    Correlation of mortality with the severity and duration of coagulopathy

    Measured: 5 years from start of trial

  4. Bleeding and infections and length of stay in hospital

    Correlation of bleeding and infections and length of stay in hospital

    Measured: 5 years from start of trial

  5. 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

    Measured: 5 years from start of trial

  6. Safety by grade 3 or 4 toxicity

    Assessment of safety by grade 3 or 4 toxicity

    Measured: 5 years from start of trial

  7. Time to initiation of treatment from diagnosis

    Correlation of outcomes with time to initiation of treatment from diagnosis

    Measured: 5 years from start of trial

  8. Outcomes across different treatment centers

    Comparison of outcomes across different treatment centers.

    Measured: 5 years from start of trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionNov 2016
  4. Study completionSep 2018

Why it stopped: Previous principal investigators left institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
117 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02309333
Sponsor's protocol ID
IRB00067432
Other IDs
WINSHIP2488-13
Status last verified
Dec 2018
First submitted
3 Dec 2014
Last updated
10 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jillella AP, Arellano ML, Gaddh M, Langston AA, Heffner LT, Winton EF, McLemore ML, Zhang C, Caprara CR, Simon KS, Bolds SL, DeBragga S, Karkhanis P, Krishnamurthy SH, Tongol J, El Geneidy MM, Pati A, Gerber JM, Grunwald MR, Cortes J, Bashey A, Stuart RK, Kota VK. Comanagement Strategy Between Academic Institutions and Community Practices to Reduce Induction Mortality in Acute Promyelocytic Leukemia. JCO Oncol Pract. 2021 Apr;17(4):e497-e505. doi: 10.1200/OP.20.00395. Epub 2020 Oct 30.

    PubMed 33125295

Questions about this trial

What is this clinical trial studying?

An observational study of Leukemia, Promyelocytic, Acute, run by Emory University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Previous principal investigators left institution). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality in the first month after diagnosis (time frame: 1 month after diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02309333, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.

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