Outcomes of Acute Myeloid Leukemia Patients

Acute Myeloid Leukemia Clinical Trial

Official title:

Outcomes of Acute Myeloid Leukemia Patients in Assiut University Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04392310
• Other study ID #: Outcomes of AML
• Status: Not yet recruiting
• Start date: June 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• AML patients, aged more than 18yrs and received chemotherapy (aggressive or palliative).

Exclusion Criteria:

• patients less than 18years old.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the overall survival of AML patients.	Assessment of the overall survival of AML patients.	One year