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.
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.
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:
- what is the impact of cytogenetics abnormalities [e.g., IGHV mutation status, del(17p)] on patients' treatment response?
- 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.
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- 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)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.
- First posted9 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sawsan abdelllah, Assiut University
- Investigators
- Mai Mostafa Mohamed, MD, Study director, assuit univeristy hospitalsMohamed Ramadan Abdel-Hameed, MD, Study director, assuit univeristy hospitals
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 15728813Korsholm 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinico-hematological and Molecular Characteristics on Treatment Outcomes of Chronic Lymphocytic Leukemia Patients
- ClinicalTrials.gov ID
- NCT07162532
- Acronym / sponsor ID
- molecular characters of CLL
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- what is the impact of cytogenetics abnormalities [e.g., IGHV mutation status, del(17p)] on patients' treatment response?
- 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).
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years newly diagnosed with CLL.
- Adequate diagnostics (flowcytometry and cytogenetics) and follow-up data (at least 1 year).
- Patients giving informed consent.
Key exclusion criteria (3 listed)
- Incomplete diagnostics (e.g. flowcytometry of cytogenetics)
- Lost to follow-up within 12 months of diagnosis.
- Refused to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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,ESRComplete 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. | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publication: PubMed 15728813Chiorazzi 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.
- Results publication: PubMed 39509142Korsholm 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.
- Individual participant dataSharing planned: Undecided
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HPC Offered for PRESERVE Expansion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mai Mostafa Mohamed, MD study director
assuit univeristy hospitals
Mohamed Ramadan Abdel-Hameed, MD study director
assuit univeristy hospitals
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.