Clinical trial NCT05057299: Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes
Official title: Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Keywords: AML
leukemia,
myeloid sarcoma
extramedullary disease
Lead sponsor: King Hussein Cancer Center
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS),
timeFrame: "4 year, year 4"
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: "4 year, year 4"
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
References:
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.
citation: 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.