Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes

September 15, 2021 updated by: Khaled Halahleh, King Hussein Cancer Center
Patients with extramedullary leukemia were identified over 10 years (January 2003 to September 2019). Clinicopathological,genetic-molecular features were identified and survival outcomes were studied and analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We retrospectively collected patients demographics ,including clinicopathological and genetic-molecular parameters in patients with extramedullary leukemia between January 2003 till September 2019 from King Hussein cancer center(KHCC) electronic medical records. All potential prognostic factors were identified and compared with worldwide data published previously. Treatment and survival outcomes were studies and analyzed.

Primary endpoint : Overall survival (OS).

Secondary endpoint :

  • Progression Free Survival (PFS).
  • incidence of extramedullary leukemia.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11941
        • King Hussein Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with eAML and treated at medical oncology department of KHCC-lymphoma section between January 2003-september 2019.Patients identified by searching KHCC registry databases, using key terms of myeloid sarcoma, granulocytic sarcoma, chloroma, AML, MDS, MPN, relapse. All clinicopathological and molecular data were collected and cases, that satisfied the WHO criteria for the diagnosis of myeloid sarcoma were included in the study. The clinicopathological data included age, sex, prior diagnoses and treatment, disease location, phenotype using flow cytometry or immunohistochemistry, status of bone marrow disease (prior, concurrent or after diagnosis of eAMl), treatment for eAML and their overall survival.

Description

Inclusion Criteria:

  • Adult subjects aged ≥18 year and up to 75 years
  • Male and females.
  • Initially diagnosed and treated with extramedullary leukemia at KHCC and followed till last encounter.
  • Patients, who underwent an allogeneic stem cell transplant.
  • Period January 2003-September 2019

Exclusion Criteria:

  • Pediatric patients <18 year of age
  • Patients, who lost their follow up within study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with extramedullary leukemia(eAML) with myeloid neoplasms
Other: retrospective data analysis
chart review, analysis and reporting outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS),
Time Frame: "4 year, year 4"
To calculate the median and estimated 4-year overall survival
"4 year, year 4"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: "4 year, year 4"
To calculate the median and estimated 4-year PFS
"4 year, year 4"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Hussein Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (ACTUAL)

September 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20 KHCC 169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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