Acute Myeloid LeukemiaNCT07146542
Expression Pattern and Possible Clinical Significance of CD81 In Myeloid Leukemia
An observational study of Acute Myeloid Leukemia and Chronic Myeloid Leukemia, run by Assiut University.
Trial summary
The goal of this study is to understand how the protein CD81 affects myeloid leukemia (especially AML) and whether it can help predict patient outcomes or guide treatment. The main question it aims to answer: Is high CD81 expression in myeloid leukemia cells linked to more aggressive disease, poorer treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Chronic Myeloid Leukemia
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to Mar 2028
- 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: Myeloid leukemia patients
Who may be able to join
- 1. Myeloid leukemia patients 2. Patients of both genders (Males and females) at any age 3. Cases are de novo (Not on treatment)
Who cannot join
- . Patients with other haematological neoplasms (ALL,CLL, plasma cell myeloma, etc)
- Patients under any therapeutic intervention
- Patients with current or previous other malignancies at time of diagnosis
About this study
The goal of this study is to understand how the protein CD81 affects myeloid leukemia (especially AML) and whether it can help predict patient outcomes or guide treatment.
The main question it aims to answer:
Is high CD81 expression in myeloid leukemia cells linked to more aggressive disease, poorer treatment response, or shorter survival in patients?
Participants:
- Newly diagnosed myeloid leukemia patients (primary focus on AML)
- Bone marrow or blood samples will be collected during routine diagnostic procedures
Read the detailed description
CD81, a cell surface protein belonging to the tetraspanin family, is overexpressed in 60-90% of acute myeloid leukemia (AML) patients and correlates with aggressive disease manifestations. Clinically, CD81-positive AML demonstrates elevated total leucocytic counts, increased lactate dehydrogenase (LDH) levels, higher bone marrow blast percentages, and a predominance in M1-M5 French-American-British (FAB) subtypes. Critically, this marker predicts adverse outcomes: reduced complete remission rates (12% vs. 24% in CD81-negative cohorts), higher relapse incidence (38% vs. 12%), and inferior overall, event-free, and relapse-free survival. Multivariate analyses confirm CD81 as an independent prognostic indicator, even within cytogenetically normal AML or NPM1-mutated subgroups.
Current AML risk stratification depends heavily on cytogenetic and molecular profiling (e.g., NPM1, FLT3-ITD). Nevertheless, 40-50% of patients lack identifiable high-risk genetic lesions, complicating clinical prognostication. Although flow cytometry enables rapid detection of CD81 surface expression, this biomarker remains underutilized in risk models despite its adverse impact mirroring established high-risk features. Mechanistically, CD81s involvement in metastasis and stem cell quiescence positions it as both a prognostic tool and a candidate therapeutic target.
Notably, CD81 expression remains uncharacterized in chronic myeloid leukemia (CML). Given CMLs distinct BCR::ABL1-driven pathogenesis and clinical trajectory from chronic phase to blast crisis, evaluating CD81s role may reveal novel biological insights or therapeutic vulnerabilities during disease progression.
- Conditions
- Acute Myeloid Leukemia, Chronic Myeloid Leukemia
- Keywords
- CD81, AMl, CML, Myeloid, Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with myeloid leukemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of CD81 in patients with myeloid leukemia
percentage of expression of CD81 in myeloid leukemia
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hesham Abdel Raheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146542
- Sponsor's protocol ID
- CD81 In Myeloid Leukemia
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression Pattern and Possible Clinical Significance of CD81 In Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07146542
- Acronym / sponsor ID
- CD81 In Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia, Chronic Myeloid Leukemia
- Keywords
- CD81, AMl, CML, Myeloid, Leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Aug 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 understand how the protein CD81 affects myeloid leukemia (especially AML) and whether it can help predict patient outcomes or guide treatment.
The main question it aims to answer:
Is high CD81 expression in myeloid leukemia cells linked to more aggressive disease, poorer treatment response, or shorter survival in patients?
Participants:
- Newly diagnosed myeloid leukemia patients (primary focus on AML)
- Bone marrow or blood samples will be collected during routine diagnostic procedures
Detailed description
CD81, a cell surface protein belonging to the tetraspanin family, is overexpressed in 60-90% of acute myeloid leukemia (AML) patients and correlates with aggressive disease manifestations. Clinically, CD81-positive AML demonstrates elevated total leucocytic counts, increased lactate dehydrogenase (LDH) levels, higher bone marrow blast percentages, and a predominance in M1-M5 French-American-British (FAB) subtypes. Critically, this marker predicts adverse outcomes: reduced complete remission rates (12% vs. 24% in CD81-negative cohorts), higher relapse incidence (38% vs. 12%), and inferior overall, event-free, and relapse-free survival. Multivariate analyses confirm CD81 as an independent prognostic indicator, even within cytogenetically normal AML or NPM1-mutated subgroups.
Current AML risk stratification depends heavily on cytogenetic and molecular profiling (e.g., NPM1, FLT3-ITD). Nevertheless, 40-50% of patients lack identifiable high-risk genetic lesions, complicating clinical prognostication. Although flow cytometry enables rapid detection of CD81 surface expression, this biomarker remains underutilized in risk models despite its adverse impact mirroring established high-risk features. Mechanistically, CD81s involvement in metastasis and stem cell quiescence positions it as both a prognostic tool and a candidate therapeutic target.
Notably, CD81 expression remains uncharacterized in chronic myeloid leukemia (CML). Given CMLs distinct BCR::ABL1-driven pathogenesis and clinical trajectory from chronic phase to blast crisis, evaluating CD81s role may reveal novel biological insights or therapeutic vulnerabilities during disease progression.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –patients with myeloid leukemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Myeloid leukemia patients
Key inclusion criteria (1 listed)
- 1. Myeloid leukemia patients 2. Patients of both genders (Males and females) at any age 3. Cases are de novo (Not on treatment)
Key exclusion criteria (3 listed)
- . Patients with other haematological neoplasms (ALL,CLL, plasma cell myeloma, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
expression of CD81 in patients with myeloid leukemia
Time frame: baseline
percentage of expression of CD81 in myeloid leukemia
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 28 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Chronic Myeloid Leukemia, 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 1 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 28 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expression of CD81 in patients with myeloid leukemia (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025.