Chronic Myeloid Leukemia (CML)NCT06865443
Evaluation of CD47, "Do Not Eat Me" Signal Expression in Chronic Myeloid Leukemia
An observational study of Chronic Myeloid Leukemia (CML), run by Assiut University.
Trial summary
Chronic myeloid leukemia is a myeloid neoplasm characterized by the overproduction of mature granulocytes . Cluster of differentiation 47 (CD47) is a membrane protein, which is over-expressed by virtually all cancers and regulates many signaling systems associated with tumor growth and invasion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Myeloid Leukemia (CML)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Jul 2026
- Phase
- Observational
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: CML patients, who fulfill the WHO 2022 criteria
Who may be able to join
- age more than 18 years
- both sex
- CML patients, who fulfill the WHO 2022 criteria
Who cannot join
- Patients with other haematological neoplasms (ALL,CLL, plasma cell myeloma)
About this study
Chronic myeloid leukemia is a myeloid neoplasm characterized by the overproduction of mature granulocytes . Cluster of differentiation 47 (CD47) is a membrane protein, which is over-expressed by virtually all cancers and regulates many signaling systems associated with tumor growth and invasion. Following CD47 binding to the inhibitory receptor (signal regulatory protein, SIRPα) on macrophages, the CD47-receptor complex sends a "do not eat me" anti-phagocytic signal to prevent phagocytosis . This balance is tipped by cancer cells, which adopt the "self" signal and upregulate CD47 expression to evade immune surveillance and subsequent destruction. Elevated expression of CD47 has been observed in ovarian carcinoma cell lines , murine myeloid leukemias , leukemic stem cells and several solid tumors .
Flow cytometry revealed high surface expression of CD47 on 73% of samples collected from the bone marrow of multiple myeloma (MM) patients .
Read more
High CD47 expression on six different primary effusion lymphoma (PEL) cell lines compared to peripheral blood mononuclear cells (PBMC) was found . Additionally, in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and several non-Hodgkin's lymphoma (NHL) subtypes, increased CD47 expression is correlated with adverse clinical outcomes .
Hematological malignancies, even at onset, present with widespread bone marrow and peripheral blood involvement and many are still without effective systemic curative therapies . Most CML patients have deep and durable responses when treated with BCR::ABL1 tyrosine kinase inhibitors, which might be influenced by long-term toxicities during the treatment .
CD47 "don't eat me signal" expression not evaluated in CML. the aim of the study To detect CD47 expression by flow cytometry in CML patients. To study the correlation between BCR::ABL1 gene and CD47 expression in CML patients . Evaluation of the role CD47 as predictor of CML patient outcome
- Conditions
- Chronic Myeloid Leukemia (CML)
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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 | CML patients, who fulfill the WHO 2022 criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD47 Signal Expression in Chronic Myeloid Leukemia
CD47 Signal Expression in Chronic 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 posted7 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia (CML)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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ehab Fawzy Abdou, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865443
- Sponsor's protocol ID
- CD47 Chronic Myeloid Leukemia
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No