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Not yet recruitingNCT07162532Updated Sep 9, 2025

Clinico-hematological and Molecular Characteristics of Chronic Lymphocytic Leukemia Patients

An observational study in Chronic Lymphocytic Leukemia (CLL), sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
45
Ages
18 Years and older
Sex
All
01

Study summary

the goal of this study is To describe the clinical, hematologic, and cytogenetic characteristics of CLL cases.

The main questions it aims to answer are:

  1. what is the impact of cytogenetics abnormalities [e.g., IGHV mutation status, del(17p)] on patients' treatment response?
  2. what is th correlation between clinical and hematological characteristic with patients' outcome.

All participants will be subjected to history taking , Physical examination. and Laboratory investigations (Complete blood picture Cytogenetic profiles: del(17p) molecular study :IGHV mutation status).

Read the detailed description

Chronic Lymphocytic Leukemia (CLL) is a CD 5 positive hematological malignancy that is characterized by the excess accumulation of small, mature appearing neoplastic B lymphocytes in the blood, marrow, and other lymphoid tissues, resulting in lymphocytosis, leukemia cell infiltration of the marrow, lymphadenopathy, and splenomegaly. Clonal B lymphocytes with a distinctive immunophenotype where B-cell markers (CD19, CD23) are expressed along with CD5, with low-level expression of CD20 and surface immunoglobulins . CLL is more common in men than women, and its incidence varies geographically, with higher rates reported in Western countries [5]. Clinical characteristics in the form of organomegaly and lymphadenopathy in addition to hematological characteristics in the form of lymphocytosis and cytopenia affect disease coarse and patients' outcome .The clinical course of CLL is highly variable, ranging from indolent disease that may never require treatment to aggressive forms that necessitate prompt intervention. Some patients may remain asymptomatic for many years, while others may experience symptoms such as fatigue, weight loss, and recurrent infections due to immune dysfunction . Cytogenetic and molecular genetic studies have identified a range of genetic abnormalities in CLL, including deletions, translocations, and mutations . These genetic alterations can affect the behavior of the disease and influence treatment outcomes.

Recently immunological (flowcytometry), and cytogenetic characters namely deletion 17p and immunoglobulin heavy chain gene (IgVH) mutation of CLL patients added more impact of patients' morbidity and response to treatment .

Recent research has focused on the development of targeted therapies for CLL, including venetoclax-based regimens and Bruton tyrosine kinase inhibitors . These agents have shown promise in improving outcomes for patients with CLL, particularly those with high-risk disease or refractory/relapsed disease .

New studies have also explored the role of novel therapies in CLL treatment, including combination regimens and immunotherapies. These approaches have shown encouraging results in early clinical trials, and may offer new options for patients with CLL. in this study we will study the impact of cytogenetics abnormalities [e.g., IGHV mutation status, del(17p)] on patients' treatment response.

A-History taking and clinical examination.

All participants will be subjected to the following: history taking including age at diagnosis, gender, residence, occupation, smoking, comorbidities, duration and symptoms .

Physical findings (lymphadenopathy, splenomegaly, hepatomegaly) Dates of diagnosis, treatment start and type and response to treatment. Treatment and Outcome: First-line therapy, response (CR, PR, SD, PD), follow-up, survival status (PFS, overall survival (OS)) B- Laboratory investigations

Complete blood picture (CBC) with blood film, lymphocytic count Routine liver and kidney function and viral hepatitis Immunophenotyping LDH Coomb's tests Erythrocyte sedimentation rate (ESR). C reactive protein (CRP). Cytogenetic profiles: del(17p) molecular study :IGHV mutation status. C- Other investigation MSCT neck, chest, abdomen, and pelvis.

02

Conditions studied

  • Chronic Lymphocytic Leukemia (CLL)
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

1,603 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 243 are open to participants now.

This study's planned enrollment of 45 is below the median of 146 across 187 observational studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  1. Age ≥ 18 years newly diagnosed with CLL.
  2. Adequate diagnostics (flowcytometry and cytogenetics) and follow-up data (at least 1 year).
  3. Patients giving informed consent.

Inclusion criteria

  • Age ≥ 18 years newly diagnosed with CLL.
  • Adequate diagnostics (flowcytometry and cytogenetics) and follow-up data (at least 1 year).
  • Patients giving informed consent.

Exclusion criteria

Exclusion Criteria:

  • Incomplete diagnostics (e.g. flowcytometry of cytogenetics)
  • Lost to follow-up within 12 months of diagnosis.
  • Refused to give informed consent
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
45 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic test1 Complete blood picture (CBC) with blood film, lymphocytic count 2 and viral hepatitis 3 Immunophenotyping 4 LDH 5 Coomb's tests ,deletion 17p,IGVH mutation,ESR

    Complete blood picture (CBC) with blood film, lymphocytic count 2 Routine liver and kidney function and viral hepatitis 3 Immunophenotyping 4 LDH 5 Coomb's tests 6 Erythrocyte sedimentation rate (ESR). 7 C reactive protein (CRP). 8 Cytogenetic profiles: del(17p) 9 molecular study :IGHV mutation status.

06

What researchers measure

Primary outcomes

  1. 1)A detailed profile of genetic characteristics in CLL patients . 2)Identification of relation between IGHV Mutation and treatment response.(complete remission,partial remission,stable disease,progressive disease and minimal residual disease response)

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Chiorazzi N, Rai KR, Ferrarini M. Chronic lymphocytic leukemia. N Engl J Med. 2005 Feb 24;352(8):804-15. doi: 10.1056/NEJMra041720. No abstract available. PubMed 15728813 ↗
  • Korsholm C, Bulow C, Christensen M, Dalhoff K, Feinberg JB, Lund TM, Niemann CU, Petersen TS, Andersen MA. Drug exposure and measurable residual disease in chronic lymphocytic leukemia: a systematic review. Leuk Lymphoma. 2025 Feb;66(2):229-239. doi: 10.1080/10428194.2024.2412289. Epub 2024 Nov 7. PubMed 39509142 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07162532
Lead sponsor
Assiut University
Responsible party
sawsan abdelllah (specialist of clinical hematology, Assiut University) — Principal investigator
First posted
Sep 9, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Aug 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Sep 9, 2025

Study contacts

sawsan abdellah abdelaal, master degree
Contact
sawsan.abdellah@yahoo.com
00201032203190
Mai Mostafa Mohamed, MD
Contact
maialy24983@gmail.com
00201223971678
Mai Mostafa Mohamed, MD
study director · assuit univeristy hospitals
Mohamed Ramadan Abdel-Hameed, MD
study director · assuit univeristy hospitals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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