Acute Myeloid LeukemiaNCT05512104
Clinical Characters and Outcome of Acute Myeloid Leukemia Patients on Correlation to CD200 and CD56 Expression
An observational study of Acute Myeloid Leukemia, run by Assiut University.
Trial summary
estimation of the clinical characters and out come of adult acute myeloid leukemia patients correlation of the estimated clinical characters and outcome to the expression of CD200 Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- bone marrow aspirate and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: newly diagnosed Adult patients with AML, were treated with 3+7 protocol consists of 3 days doxorubicin (45mg/m2 ) and 7 days cytarabine (100-200 mg/m2 IV continuous infusion over 24 hours
Who may be able to join
- newly diagnosed Adult patients with AML, were treated with 3+7 protocol consists of 3 days doxorubicin (45mg/m2 ) and 7 days cytarabine (100-200 mg/m2 IV continuous infusion over 24 hours
Who cannot join
- 1-Promyelocytic leukemia (M3)
- Secondary acute myeloid leukemia
- aml patients above the age of 60 yrs
- aml patients with end organ failure
- patient not candidate for (3+7)
Trial locations and contacts
No sites are listed yet.
mohamed ramadan, MD contact
About this study
estimation of the clinical characters and out come of adult acute myeloid leukemia patients
- correlation of the estimated clinical characters and outcome to the expression of CD200
Read the detailed description
Acute myeloid leukemia (AML) is a clonal malignant disease of the hematopoietic tissue. The diversity of the clinical, the hematological and the genetic features among patients with AML has been recognized. Considerable progresses in defining new diagnostic and prognostic markers have been applied in AML treatment. The detection of specific molecules in the leukemic cells has special relevance and is mandatory for the identification of certain subtypes of myeloid neoplasms (Arber
- CD200 is a trans-membrane cell surface glycoprotein belonging to the type1 immunoglobulin super family (Wright , ). Expression of CD200 is normally seen in some population of T and B-lymphocytes, neurons and endothelial cells (Wright). CD200 induces immunosuppression through engagement with CD200R, a cell-surface receptor homolog, which is expressed on leukocytes of myeloid lineage, including mast-cells, macrophages, basophils, dendritic cells as well as certain T-cell populations. CD200, which is frequently over expressed in AML blasts and is associated with a worse outcome. It has the potential to induce the formation of CD4+ CD25+ FoxP3+ regulatory T cells (Tregs), a subset of immunosuppressive T cells that are linked with a poor prognosis in AML (Coles ). Abstract Background: Acute myeloid leukemia (AML) escape from immunosurveillance by immunosuppression. CD200 and CD56 expression represented an independent prognostic factor in many hematological malignancies but its importance in AML patients remains to be identified. Methods: CD200 and CD56 expression were assessed in the bone marrow blasts for Fifty-two (51) newly diagnosed AML by flowcytometry before start of therapy. Conclusions: CD200 and CD56 positive expression by myeloblasts at diagnosis denote poor prognostic indicator and correlated with poor cytogenetic findings. CD200 could be used as therapeutic target in AML. Keywords: CD200- CD56- AML- Prognosis RESEARCH ARTICLE Clinical Significance of CD200 and CD56 Expression in Patients with Acute Myeloid Leukemia, Leukemic cells express leukemia-associated antigen, MHC, co stimulatory molecules and ligands for natural killer (NK) cells activating receptors, therefore leukemic cells are susceptible to be attacked by T and NK cells (el-Shami ). CD56 antigen, a 200-220 kDa cell surface glycoprotein, identified as an isoform of the neural adhesion molecules (NCAM) (Gattenlöhner ). CD56 firstly described as NK cell and then found in several hematopoietic malignancies including AML (Yoshida ). CD56 was associated with poor prognosis in patients with acute myeloid leukemia (Alegretti ). We herein, study the expression level of CD200 and CD56 in de-novo acute myeloid leukemia patients to estimate the prognostic value of their positive expressions individually in AML cases
- Conditions
- Acute Myeloid Leukemia
- Being tested
- bone marrow aspirate and biopsy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone marrow aspirate and biopsyProcedure or surgery
fiow cytometry of bone marrow aspirate
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis of Acute Myeloid Leukemia Patients on Correlation to CD200 and CD56 Expression
Prognostic value of CD200 and CD56 in acute myeloid leukemia
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 posted23 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Gamal Mohamed Abd Elaal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512104
- Sponsor's protocol ID
- CD200 and CD56 in AML
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Damiani D, Tiribelli M, Raspadori D, Sirianni S, Meneghel A, Cavalllin M, Michelutti A, Toffoletti E, Geromin A, Simeone E, Bocchia M, Fanin R. Clinical impact of CD200 expression in patients with acute myeloid leukemia and correlation with other molecular prognostic factors. Oncotarget. 2015 Oct 6;6(30):30212-21. doi: 10.18632/oncotarget.4901.
PubMed 26338961
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characters and Outcome of Acute Myeloid Leukemia Patients on Correlation to CD200 and CD56 Expression
- ClinicalTrials.gov ID
- NCT05512104
- Acronym / sponsor ID
- CD200 and CD56 in AML
- Conditions
- Acute Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 23 Aug 2022 (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.
estimation of the clinical characters and out come of adult acute myeloid leukemia patients
- correlation of the estimated clinical characters and outcome to the expression of CD200
Detailed description
Acute myeloid leukemia (AML) is a clonal malignant disease of the hematopoietic tissue. The diversity of the clinical, the hematological and the genetic features among patients with AML has been recognized. Considerable progresses in defining new diagnostic and prognostic markers have been applied in AML treatment. The detection of specific molecules in the leukemic cells has special relevance and is mandatory for the identification of certain subtypes of myeloid neoplasms (Arber
- CD200 is a trans-membrane cell surface glycoprotein belonging to the type1 immunoglobulin super family (Wright , ). Expression of CD200 is normally seen in some population of T and B-lymphocytes, neurons and endothelial cells (Wright). CD200 induces immunosuppression through engagement with CD200R, a cell-surface receptor homolog, which is expressed on leukocytes of myeloid lineage, including mast-cells, macrophages, basophils, dendritic cells as well as certain T-cell populations. CD200, which is frequently over expressed in AML blasts and is associated with a worse outcome. It has the potential to induce the formation of CD4+ CD25+ FoxP3+ regulatory T cells (Tregs), a subset of immunosuppressive T cells that are linked with a poor prognosis in AML (Coles ). Abstract Background: Acute myeloid leukemia (AML) escape from immunosurveillance by immunosuppression. CD200 and CD56 expression represented an independent prognostic factor in many hematological malignancies but its importance in AML patients remains to be identified. Methods: CD200 and CD56 expression were assessed in the bone marrow blasts for Fifty-two (51) newly diagnosed AML by flowcytometry before start of therapy. Conclusions: CD200 and CD56 positive expression by myeloblasts at diagnosis denote poor prognostic indicator and correlated with poor cytogenetic findings. CD200 could be used as therapeutic target in AML. Keywords: CD200- CD56- AML- Prognosis RESEARCH ARTICLE Clinical Significance of CD200 and CD56 Expression in Patients with Acute Myeloid Leukemia, Leukemic cells express leukemia-associated antigen, MHC, co stimulatory molecules and ligands for natural killer (NK) cells activating receptors, therefore leukemic cells are susceptible to be attacked by T and NK cells (el-Shami ). CD56 antigen, a 200-220 kDa cell surface glycoprotein, identified as an isoform of the neural adhesion molecules (NCAM) (Gattenlöhner ). CD56 firstly described as NK cell and then found in several hematopoietic malignancies including AML (Yoshida ). CD56 was associated with poor prognosis in patients with acute myeloid leukemia (Alegretti ). We herein, study the expression level of CD200 and CD56 in de-novo acute myeloid leukemia patients to estimate the prognostic value of their positive expressions individually in AML cases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- newly diagnosed Adult patients with AML, were treated with 3+7 protocol consists of 3 days doxorubicin (45mg/m2 ) and 7 days cytarabine (100-200 mg/m2 IV continuous infusion over 24 hours
Key inclusion criteria (1 listed)
- newly diagnosed Adult patients with AML, were treated with 3+7 protocol consists of 3 days doxorubicin (45mg/m2 ) and 7 days cytarabine (100-200 mg/m2 IV continuous infusion over 24 hours
Key exclusion criteria (5 listed)
- Secondary acute myeloid leukemia
- aml patients above the age of 60 yrs
- aml patients with end organ failure
- patient not candidate for (3+7)
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 |
|---|---|---|
| bone marrow aspirate and biopsyfiow cytometry of bone marrow aspirate | Procedure or surgery | – |
Primary outcome
Prognosis of Acute Myeloid Leukemia Patients on Correlation to CD200 and CD56 Expression
Time frame: 1 year
Prognostic value of CD200 and CD56 in acute myeloid leukemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 26338961Damiani D, Tiribelli M, Raspadori D, Sirianni S, Meneghel A, Cavalllin M, Michelutti A, Toffoletti E, Geromin A, Simeone E, Bocchia M, Fanin R. Clinical impact of CD200 expression in patients with acute myeloid leukemia and correlation with other molecular prognostic factors. Oncotarget. 2015 Oct 6;6(30):30212-21. doi: 10.18632/oncotarget.4901.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
mohamed ramadan, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute 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 5 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: status not confirmed, as of the sponsor's last update on 23 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact asmaa gamal, master (01091076754, asmaagamak2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis of Acute Myeloid Leukemia Patients on Correlation to CD200 and CD56 Expression (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 NCT05512104, which also lists 1 linked publication.
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 23 Aug 2022.