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Chronic Lymphocytic Leukemia (CLL)NCT07162532

Clinico-hematological and Molecular Characteristics of Chronic Lymphocytic Leukemia Patients

An observational study of Chronic Lymphocytic Leukemia (CLL), run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia (CLL)
What is being tested?
1 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
How many people
45 participants
Where
No sites listed yet
Study dates
1 Oct 2025to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

sawsan abdellah abdelaal, master degree contact

00201032203190

sawsan.abdellah@yahoo.com

Mai Mostafa Mohamed, MD contact

00201223971678

maialy24983@gmail.com

About this study

Official title: Impact of Clinico-hematological and Molecular Characteristics on Treatment Outcomes of Chronic Lymphocytic Leukemia Patients

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.

Being tested
1 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
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1 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,ESRDiagnostic test

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07162532
Sponsor's protocol ID
molecular characters of CLL
Status last verified
Jul 2025
First submitted
11 Jul 2025
Last updated
9 Sep 2025
Results posted
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia (CLL), run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact sawsan abdellah abdelaal, master degree (00201032203190, sawsan.abdellah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07162532, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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