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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05057299
• Other study ID #: 20 KHCC 169
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: September 2021
• Source: King Hussein Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• retrospective data analysis
chart review, analysis and reporting outcomes

Locations

Country	Name	City	State
Jordan	King Hussein Cancer Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
King Hussein Cancer Center

Country where clinical trial is conducted

Jordan, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS),	To calculate the median and estimated 4-year overall survival	"4 year, year 4"
Secondary	Progression-Free Survival	To calculate the median and estimated 4-year PFS	"4 year, year 4"