NCT02309333

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 10, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

December 3, 2014

Last Update Submit

December 6, 2018

Conditions

Leukemia, Promyelocytic, Acute

Outcome Measures

Primary Outcomes (1)

  • Mortality in the first month after diagnosis

    1 month after diagnosis

Secondary Outcomes (8)

  • Overall survival 18 months after accrual is completed

    18 months after accrual completion

  • Severity and duration of coagulopathy

    5 years from start of trial

  • Mortality with the severity and duration of coagulopathy

    5 years from start of trial

  • Bleeding and infections and length of stay in hospital

    5 years from start of trial

  • Differentiation syndrome and length of hospital stay

    5 years from start of trial

  • +3 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Gibbs Cancer Center and Research Institute

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (1)

  • 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.

    PMID: 33125295DERIVED

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, AcuteLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Martha Arellano, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2016

Study Completion

September 1, 2018

Last Updated

December 10, 2018

Record last verified: 2018-12

Locations

US(4)