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FLT3-ITD Gene Mutation and CD135 Expression in Acute Myeloid Leukemia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05383014
Recruitment Status : Not yet recruiting
First Posted : May 19, 2022
Last Update Posted : May 19, 2022
Information provided by (Responsible Party):
Shaimaa Abd Elazeem Saber Selim, Assiut University

Brief Summary:
  1. To evaluate expression levels of CD135
  2. To assess the frequency of FLT3 gene mutations (ITD)
  3. association between FLT3-ITD mutation and CD135 expression and their correlation with hematological, immunophenotypic,and biochemical features.

Condition or disease
Acute Myeloid Leukemia

Detailed Description:
Acute leukemias are clonal malignant diseases of immature hematopoietic system ,characterized by clonal evolution and considerable genetic, epigenetic, and phenotypic heterogeneity,and constitute a common cause of morbidity and mortality worldwide.[1] Gene expression profiling has improved the molecular classification and prognosis of Acute leukemias, where molecular testing has become mandatory for further classify into prognostic groups. Among the genetic aberrations, alterations of the FMS-like tyrosine kinase 3 (FLT3) gene. [2] FLT3 is a type 3 receptor tyrosine kinase that plays an important role in the expansion and proliferation of multi-potent progenitor cells within the bone marrow.[3] mutations of FLT3 induce a constitutional activation of tyrosine kinases and several downstream targets resulting in proliferation and growth of malignant cells ,myeloproliferative phenotype , high tumor burden,and a characteristic hematological , immunophenotypic and biochemical profile that can be identified during routine diagnostic workup.[4]Two mutations exist in these cells: FLT3-ITD (internal tandem duplication), and FLT3-TKD, a point mutation in the tyrosine kinase domain.[5] FLT3-ITD is a common driver mutation, seen with a frequency of 20 to 30% ,and significantly affecting the pathogenesis and the clinical outcome . Genetic testing for FLT3-ITD mutation at diagnosis is done to risk stratify patients and to guide therapeutic decisions.[6-8] FLT3 receptor/CD135 is a transmembrane tyrosine kinase receptor, normally expressed on the surface of hematopoietic stem cells and is lost upon cell differentiation , activation of the receptor resulting in stimulating survival and proliferation, and inhibiting apoptosis of progenitor cells . Overexpression of the FLT3 receptor has been reported to be associated with high risk for relapse in patients with acute leukemia .[2]

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Study Type : Observational
Estimated Enrollment : 82 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of Association Between FLT3-ITD Gene Mutation and CD135 Expression and Their Correlation With Hematological,Immunophenotypic and Biochemical Characteristics in Acute Myeloid Leukemia.
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : July 1, 2024

Primary Outcome Measures :
  1. Correlation between FLT3 gene mutation and the expression of CD135 and their association with clinical outcome ,haematological, immunophenotypic , biochemical characteristics in the development and progression of AML. [ Time Frame: baseline ]
    analysis of association between FLT3 gene mutation and the level of expression of CD135 and analysis of clinical outcome , hematological,and immunophenotypic characteristics between patients with positive FLT3-ITD mutation and negatine patients

Secondary Outcome Measures :
  1. To detect expression levels of CD135 and the frequency of FLT3- ITD gene mutations in the development and progression of AML -follow up of patient after induction of chemotherapy [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA
FLT3-ITD mutations will be determined from genomic DNA using polymerase chain reaction (PCR)-based method on Peripheral blood samples of AML patients

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed Patients with acute myeloid leukemia (AML), who fullfill the WHO criteria.

Inclusion Criteria:

  • Newly diagnosed Patients with acute myeloid leukemia (AML), who fullfill the WHO criteria.

Exclusion Criteria:

  • AML on top of myeloproliferative neoplasms or MDS.
  • previously diagnosed AML on treatment
  • Patients with any other type of malignant tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05383014

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Contact: Shaimaa Abdelazeem Selim, Assist. lecturer 01006214247
Contact: Hanan Galal Abdel-Azeem, prof 01062226610

Sponsors and Collaborators
Assiut University
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Study Director: Marwa Mohammed Thabet, lecturer clinical pathology department , Assiut University Hospital.
Study Director: Alaa soliman Abd Elkadir, lecturer clinical pathology department , Assiut University Hospital.

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Responsible Party: Shaimaa Abd Elazeem Saber Selim, Assist. lecturer, Assiut University Identifier: NCT05383014    
Other Study ID Numbers: FLT3-ITD and CD135 in AML
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Hematologic Diseases