Acute Myeloid LeukemiaNCT04392310
Outcomes of Acute Myeloid Leukemia Patients
An observational study of Acute Myeloid Leukemia, run by Assiut University.
Trial summary
1. To assess overall survival of AML patient. 2. To measure rate of disease free survival. 3. rate of non relapse mortality. 4. rate of complete remission . 5. percentage of refractory disease. 6. percentage of relapsed disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Nov 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute myeloid leukemia patients outcomes
Who may be able to join
- AML patients, aged more than 18yrs and received chemotherapy (aggressive or palliative).
Who cannot join
- patients less than 18years old.
About this study
Official title: Outcomes of Acute Myeloid Leukemia Patients in Assiut University Hospital
- To assess overall survival of AML patient.
- To measure rate of disease free survival.
- rate of non relapse mortality.
- rate of complete remission .
- percentage of refractory disease.
- percentage of relapsed disease.
Read the detailed description
Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow which is characterized by malignant clonal expansion and differentiation arrest of myeloid progenitor cells.
The etiology of AML is heterogeneous. In some patients, prior exposure to therapeutic, occupational or environmental DNA-damaging agents is implicated, but most cases of AML remain without a clear etiology.
The incidence of AML had been higher than that of the other three subtypes of leukemia ( [ALL], [CML], and [CLL])\& accounts for the highest percentage (62%) of leukemic deaths.
AML is primarily a disease of older adults. The age-adjusted incidence for those aged 65 years or older is 20.1 per 100,000 persones in comparison to 2.0 per 100,000 person-years for those younger than 65 years old.
Males are 1.2-1.6 times more likely to develop AML during their lifetime as evidenced by population-based studies in the US, UK, Canada, Denmark, Australia and Algeria. AML is one of the most common form of Hematological Malignancy in adults and has the shortest survival (5-year survival = 24%). Curative therapies, including intensive chemotherapy and allogeneic stem cell transplantation, are generally applicable to a minority of patients who are younger and fit, while most older individuals exhibit poor prognosis and survival. Differences in patient outcomes are influenced by disease characteristics, access to care including active therapies and supportive care, and other factors. After many years without therapeutic advances, several new therapies have been approved and are expected to impact patient outcomes, especially for older patients and those with refractory disease.
- Conditions
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the overall survival of AML patients.
Assessment of the overall survival of AML patients.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelsalam Abodeif sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392310
- Sponsor's protocol ID
- Outcomes of AML
- Status last verified
- May 2020
- First submitted
- 27 Sep 2019
- Last updated
- 18 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Kouchkovsky I, Abdul-Hay M. 'Acute myeloid leukemia: a comprehensive review and 2016 update'. Blood Cancer J. 2016 Jul 1;6(7):e441. doi: 10.1038/bcj.2016.50.
PubMed 27367478
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Acute Myeloid Leukemia Patients in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT04392310
- Acronym / sponsor ID
- Outcomes of AML
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 18 May 2020 (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.
- To assess overall survival of AML patient.
- To measure rate of disease free survival.
- rate of non relapse mortality.
- rate of complete remission .
- percentage of refractory disease.
- percentage of relapsed disease.
Detailed description
Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow which is characterized by malignant clonal expansion and differentiation arrest of myeloid progenitor cells.
The etiology of AML is heterogeneous. In some patients, prior exposure to therapeutic, occupational or environmental DNA-damaging agents is implicated, but most cases of AML remain without a clear etiology.
The incidence of AML had been higher than that of the other three subtypes of leukemia ( [ALL], [CML], and [CLL])\& accounts for the highest percentage (62%) of leukemic deaths.
AML is primarily a disease of older adults. The age-adjusted incidence for those aged 65 years or older is 20.1 per 100,000 persones in comparison to 2.0 per 100,000 person-years for those younger than 65 years old.
Males are 1.2-1.6 times more likely to develop AML during their lifetime as evidenced by population-based studies in the US, UK, Canada, Denmark, Australia and Algeria. AML is one of the most common form of Hematological Malignancy in adults and has the shortest survival (5-year survival = 24%). Curative therapies, including intensive chemotherapy and allogeneic stem cell transplantation, are generally applicable to a minority of patients who are younger and fit, while most older individuals exhibit poor prognosis and survival. Differences in patient outcomes are influenced by disease characteristics, access to care including active therapies and supportive care, and other factors. After many years without therapeutic advances, several new therapies have been approved and are expected to impact patient outcomes, especially for older patients and those with refractory disease.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute myeloid leukemia patients outcomes
Key inclusion criteria (1 listed)
- AML patients, aged more than 18yrs and received chemotherapy (aggressive or palliative).
Key exclusion criteria (1 listed)
- patients less than 18years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the overall survival of AML patients.
Time frame: One year
Assessment of the overall survival of AML patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Background: PubMed 27367478De Kouchkovsky I, Abdul-Hay M. 'Acute myeloid leukemia: a comprehensive review and 2016 update'. Blood Cancer J. 2016 Jul 1;6(7):e441. doi: 10.1038/bcj.2016.50.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Assessment of the overall survival of AML patients. (time frame: One year). 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 NCT04392310, which also lists 1 linked publication.
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 18 May 2020.