NCT06865443

Brief 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. 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 . 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started May 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
May 2025Jul 2026

First Submitted

Initial submission to the registry

March 4, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 4, 2025

Last Update Submit

March 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • CD47 Signal Expression in Chronic Myeloid Leukemia

    CD47 Signal Expression in Chronic Myeloid Leukemia

    baseline

Study Arms (1)

study group

CML patients, who fulfill the WHO 2022 criteria

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

CML patients, who fulfill the WHO 2022 criteria

You may qualify if:

  • age more than 18 years
  • both sex
  • CML patients, who fulfill the WHO 2022 criteria

You may not qualify if:

  • Patients with other haematological neoplasms (ALL,CLL, plasma cell myeloma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 7, 2025

Study Start

May 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 7, 2025

Record last verified: 2025-03