Acute Myeloid LeukemiaNCT05057299
Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes
An observational study of Acute Myeloid Leukemia, run by King Hussein Cancer Center at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- retrospective data analysis
- How many people
- 32 participants
- Where
- 1 siteJordan
- Study dates
- 1 Oct 2020to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pediatric patients <18 year of age
- Patients, who lost their follow up within study period.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- retrospective data analysis
- Keywords
- AML, leukemia,, myeloid sarcoma, extramedullary disease
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Sarcoma, Myeloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective data analysisOther
chart review, analysis and reporting outcomes
| Study group | Role | What they receive |
|---|---|---|
| Patients with extramedullary leukemia(eAML) with myeloid neoplasms | Not described Receives: Other: retrospective data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS),
To calculate the median and estimated 4-year overall survival
Measured: "4 year, year 4"
Secondary outcomes (1)
Progression-Free Survival
To calculate the median and estimated 4-year PFS
Measured: "4 year, year 4"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Oct 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Halahleh, King Hussein Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057299
- Sponsor's protocol ID
- 20 KHCC 169
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31101526Shallis 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.
PubMed 33213985
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes
- ClinicalTrials.gov ID
- NCT05057299
- Acronym / sponsor ID
- 20 KHCC 169
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, leukemia,, myeloid sarcoma, extramedullary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with extramedullary leukemia(eAML) with myeloid neoplasms | – | Other: retrospective data analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pediatric patients <18 year of age
- Patients, who lost their follow up within study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective data analysischart review, analysis and reporting outcomes | Other | Patients with extramedullary leukemia(eAML) with myeloid neoplasms |
Primary outcome
Overall survival (OS),
Time frame: "4 year, year 4"
To calculate the median and estimated 4-year overall survival
1 secondary outcome
Progression-Free Survival
Time frame: "4 year, year 4"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 31101526Shallis 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.
- Results publication: PubMed 33213985Shallis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by King Hussein Cancer Center at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS), (time frame: "4 year, year 4"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05057299, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.