NCT05383014

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

May 17, 2022

Last Update Submit

May 17, 2022

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (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.

    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

    baseline

Secondary Outcomes (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

    baseline

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Vela-Ojeda J, Cardenas PV, Garcia-Ruiz Esparza MA, Montiel Cervantes LA, Chavez JG, Caballero AH, Majluf-Cruz A, Vega-Lopez A, Reyes-Maldonado E. FLT3-ITD and CD135 Over-Expression are Frequent Findings of Poor Survival in Adult Patients with Acute Leukemias. Arch Med Res. 2021 Feb;52(2):217-223. doi: 10.1016/j.arcmed.2020.10.013. Epub 2020 Oct 24.

    PMID: 33109387BACKGROUND

  • Ambinder AJ, Levis M. Potential targeting of FLT3 acute myeloid leukemia. Haematologica. 2021 Mar 1;106(3):671-681. doi: 10.3324/haematol.2019.240754.

    PMID: 32703795BACKGROUND

  • Gilliland DG, Griffin JD. The roles of FLT3 in hematopoiesis and leukemia. Blood. 2002 Sep 1;100(5):1532-42. doi: 10.1182/blood-2002-02-0492.

    PMID: 12176867BACKGROUND

  • Juliusson G, Jadersten M, Deneberg S, Lehmann S, Mollgard L, Wennstrom L, Antunovic P, Cammenga J, Lorenz F, Olander E, Lazarevic VL, Hoglund M. The prognostic impact of FLT3-ITD and NPM1 mutation in adult AML is age-dependent in the population-based setting. Blood Adv. 2020 Mar 24;4(6):1094-1101. doi: 10.1182/bloodadvances.2019001335.

    PMID: 32203582BACKGROUND

  • Daver N, Schlenk RF, Russell NH, Levis MJ. Targeting FLT3 mutations in AML: review of current knowledge and evidence. Leukemia. 2019 Feb;33(2):299-312. doi: 10.1038/s41375-018-0357-9. Epub 2019 Jan 16.

    PMID: 30651634BACKGROUND

  • Khera R, Ahmed F, Mundada M, Nambaru L, Murthy SS, Devig S, Rajappa SJ, Mallavarapu KM, Santa A, Kumar P. Acute Myeloid Leukaemia with Gene Mutation: A Correlation with Haematological and Immunophenotypic Characteristics and Our Experience in a Tertiary Care Cancer Center in South India. Turk Patoloji Derg. 2018;34(2):171-174. doi: 10.5146/tjpath.2017.01415.

    PMID: 28984348BACKGROUND

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

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Marwa Mohammed Thabet, lecturer

    clinical pathology department , Assiut University Hospital.

    STUDY DIRECTOR

  • Alaa soliman Abd Elkadir, lecturer

    clinical pathology department , Assiut University Hospital.

    STUDY DIRECTOR

Central Study Contacts

Shaimaa Abdelazeem Selim, Assist. lecturer

CONTACT

01006214247Shaimaaselim95@gmail.com

Hanan Galal Abdel-Azeem, prof

CONTACT

01062226610Hanangalal2000@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. lecturer

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 19, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

May 19, 2022

Record last verified: 2022-05