NCT05057299

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 2, 2021

Last Update Submit

September 15, 2021

Conditions

Keywords

AMLleukemia,myeloid sarcomaextramedullary disease

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS),

    To calculate the median and estimated 4-year overall survival

    "4 year, year 4"

Secondary Outcomes (1)

  • Progression-Free Survival

    "4 year, year 4"

Study Arms (1)

Patients with extramedullary leukemia(eAML) with myeloid neoplasms

Other: retrospective data analysis

Interventions

chart review, analysis and reporting outcomes

Patients with extramedullary leukemia(eAML) with myeloid neoplasms

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmales and females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Hussein Cancer Center

Amman, 11941, Jordan

Location

Related Publications (2)

  • Shallis RM, Wang R, Davidoff A, Ma X, Zeidan AM. Epidemiology of acute myeloid leukemia: Recent progress and enduring challenges. Blood Rev. 2019 Jul;36:70-87. doi: 10.1016/j.blre.2019.04.005. Epub 2019 Apr 29.

    PMID: 31101526BACKGROUND
  • Shallis RM, Gale RP, Lazarus HM, Roberts KB, Xu ML, Seropian SE, Gore SD, Podoltsev NA. Myeloid sarcoma, chloroma, or extramedullary acute myeloid leukemia tumor: A tale of misnomers, controversy and the unresolved. Blood Rev. 2021 May;47:100773. doi: 10.1016/j.blre.2020.100773. Epub 2020 Oct 30.

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemiaSarcoma, Myeloid

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesSarcomaNeoplasms, Connective and Soft Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Medical Oncologist-BMT consultant

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 27, 2021

Study Start

October 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations