Outcomes of Acute Myeloid Leukemia Patients

Outcomes of Acute Myeloid Leukemia Patients in Assiut University Hospital

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia

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 Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute myeloid leukemia patients outcomes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients less than 18years old.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the overall survival of AML patients.	Assessment of the overall survival of AML patients.	One year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (ACTUAL): May 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: Outcomes of AML

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No