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NCT Number: NCT07157579

Notch 1 Mutation in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patient

* Detection of Notch1 mutation in BM or peripheral blood of of patients with NHL * Detection of Notch1 mutation in BM or peripheral blood of of patients with chronic lymphocytic leukemia . * Comparison between expression of mutation in patient with CLL and NHL.

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Key information

About this study

Chronic Lymphocytic Leukemia (CLL), is the most common leukemia in the western world. with a higher incidence in males (1.7:1),Current treatment strategies vary depending on disease burden, from active monitoring in asymptomatic patients, to targeted therapies in more advanced disease.

CLL is characterized by the clonal expansion of B cells with a characteristic immunophenotype (i.e., smIgweak, CD29+, CD23+, CD20weak) that slowly accumulate in peripheral blood, bone marrow, and lymphoid tissues mainly as a result of defects in the apoptosis machinery such as the overexpression of Bcl2 family anti-apoptotic proteins .

The clinical heterogeneity of CLL does reflect differences in the biology of the disease, particularly the IGHV mutational status and chromosomal alterations (i.e., del13q, del11q, trisomy 12 and del17p). Beside del17p/TP53 mutation which is the strongest CLL biomarker for response to therapy, other mutations (e.g., SF3B1, ATM, NOTCH1, BRIC3) have been reported to correlate with the outcome of the disease, but they are not actionable yet .

Non-Hodgins's lymphoma (NHL), the most common hematological malignancy worldwide, refers to a diverse class of B-cell and T-cell proliferations. NHL is differentiated from Hodgkin's lymphoma by different clinical characteristics and the absence of Reed-Sternberg cells and Cd15 and Cd30 staining on histology .

There are over 40 major subtypes, the most common types include indolent follicular lymphoma (FL) and aggressive diffuse large B-cell lymphoma (DLBCL). Each type is associated with unique driver genetic mutations (e.g., 14:18 translocation in FL, 11:14 translocation in Mantle Cell, 8:14 in Burkitts lymphoma ) and unique risk factors (Epstein-Barr Virus (EBV) for Burkitt's lymphoma, human T-cell lymphoma virus (HTLV-1) for T-cell lymphoma (de Leval et Jaffe,2020) The NOTCH gene was first named in studies of Drosophila melanogaster with notched wings in the 1910s, Homologs of NOTCH were then identified in multiple metazoans, and all these NOTCH homologs shared similar structures and signaling components.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

IncluInclusion criteria: approval to sign an informed written consent, patient with NHL and CLL .

Exclusion criteria

Refusal to sign an informed written consent, patient on chemotherapy sion Criteria:

Treatment and study plan

Detection of Notch1 mutation using real time pcr on bone marrow aspirate samples or peripheral blood samples.

Diagnostic Test

Detection of Notch1 mutation using real time pcr on bone marrow aspirate samples or peripheral blood samples.

Primary outcomes

  1. -Detection of Notch1 mutation in BM or peripheral blood of of patients with NHL and patients with chronic lymphocytic leukemia . - Comparison between expression of mutation in patient with CLL and NHL using real time pcr

    Time frame: baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Hayam Gamal Ahmed

CONTACT

[email protected]

01093522899

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Study of Notch 1 Mutation in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patient

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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