Chronic Myeloid LeukemiaNCT05387330
Dynamic Changes in the Levels of sCD62L and SPARC in Chronic Myeloid Leukemia Patients During Imatinib Treatment
An observational study of Chronic Myeloid Leukemia, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to monitor the levels of soluble L-selectin (sCD62L) and secreted protein acidic rich in cysteine (SPARC) in chronic phase chronic myeloid leukemia (CP-CML) patients at baseline and after three and six months of imatinib therapy and evaluated the effect of imatinib on their levels and correlated their… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- ELISA kit
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 28 Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Newly diagnosed CP-CML patients were invited to be enrolled in this study. Patients were diagnosed according to ELN guidelines. Full patient history taken and proper information sheets completed for all participants.
Who may be able to join
- Both sexes.
- Newly diagnosed patient with chronic phase, Philadelphia chromosome positive (Ph+) CML.
- Age ≥ 18 years.
Who cannot join
- Patients in blastic or accelerated phase of chronic myeloid leukemia.
- Previous treatment with Imatinib.
- Pregnancy and lactation.
- Severe hepatic dysfunction.
- Kidney dysfunction.
- Intolerant or incompliant to imatinib.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring of Soluble L-selectin (sCD62L) and Secreted Protein Acidic Rich in Cysteine in Chronic Myeloid Leukemia Patients Treated by Imatinib
This study aims to monitor the levels of soluble L-selectin (sCD62L) and secreted protein acidic rich in cysteine (SPARC) in chronic phase chronic myeloid leukemia (CP-CML) patients at baseline and after three and six months of imatinib therapy and evaluated the effect of imatinib on their levels and correlated their levels to clinical and laboratory parameters.
Read the detailed description
Chronic myelogenous leukemia (CML) is a clonal myeloproliferative disorder characterized by the reciprocal t (9:22) chromosomal translocation. This rearrangement produces abnormal chromosome called Philadelphia chromosome carrying the chimeric BCR-ABL oncoprotein which encodes for tyrosine kinase (TK). The Break Point Cluster Region- Abelson (BCR-ABL) fusion oncoprotein activates the various downstream signaling pathways causing reduced hematopoietic cell differentiation, decreased apoptosis, enhance proliferation and survival of leukemic cells. CML remains incurable for the most part, and only allogeneic hematopoietic stem cell transplantation can eradicate and cure CML. This is probably because quiescent leukemic stem cells are resistant to tyrosine kinase inhibitors (TKIs).
Imatinib (IM) was the first tyrosine kinase inhibitor to receive approval by the Food and Drug Administration for the treatment of patients with CML-CP. It acts via competitive inhibition at the ATP - binding site of the BCR-ABL protein, which results in the inhibition of phosphorylation of proteins involved in signal transduction. It inhibits the BCR-ABL kinase.
L-selectin is a glycoprotein which is one of three members in a family of cell adhesion molecules called selectins. L-selectin is expressed on most leukocytes and it appears to play an important role in the early stages of leukocyte-endothelial cell interaction. L-selectin is a critical molecule for the leukocyte-endothelial cell interaction that results in migration of naïve T-cells into peripheral lymph nodes and inflammatory locales such as: tumor microenvironment.
Secreted Protein, Acidic Rich in Cysteine (SPARC) is a multi-functional matricellular glycoprotein with growth inhibitory and anti-angiogenic activity in some cell types. This protein has counter adhesive properties, has effects on cell shape, immune surveillance, angiogenesis and inhibits cell proliferation. SPARC is multifunctional calcium binding matricellular glycoprotein, participates in tissue remodeling, morphogenesis and bone mineralization and is secreted by different types of cells such as: osteoblasts, fibroblasts and endothelial cells. SPARC binds Vascular Endothelial Growth Factor (VEGF), preventing VEGF induced tyrosine phosphorylation of VEGFR1 and antagonizing its pro-angiogenic effects. The role of SPARC in tumor genesis appears to be cell-type specific due to its diverse function in given microenvironment.
sCD62L and SPARC analyzed using commercially available ELISA kit.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- ELISA kit
- Keywords
- Soluble L-selectin, sCD62L, SPARC, Imatinib, 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.
ELISA kitDiagnostic test
Sandwich ELISA kit for the accurate quantitative detection of sCD62L and SPARC in human plasma and serum samples.
| Study group | Role | What they receive |
|---|---|---|
| CP-CML patients | Twenty five newly diagnosed CP-CML patients. Plasma sCD62L and serum SPARC levels were measured using commercially available ELISA kits Receives: Diagnostic Test: ELISA kit | |
| Control | Ten matched controls were enrolled. Plasma sCD62L and serum SPARC levels were measured using commercially available ELISA kits Receives: Diagnostic Test: ELISA kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic changes of sCD62L and SPARC levels in CP-CML patients during imatinib treatment
Monitoring the changes in sCD62L and SPARC levels at baseline and after three and six months of imatinib treatment
Measured: Baseline and after three and six months of treatment
Secondary outcomes (1)
Correlations of sCD62L or SPARC levels with laboratory and clinical parameters
Correlations of sCD62L or SPARC levels with BCR-ABL1%, sokal risk score, spleen size, age and white blood cells, neutrophils, monocytes and lymphocytes counts at baseline and after three and six months of imatinib treatment
Measured: Baseline and after three and six months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Apr 2018
- Primary completion25 Jul 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Elkholy, Tanta University
- Investigators
- Mahmoud M Elkholy, Bachelor, Principal investigator, Clinical Pharmacy Department, Faculty of Pharmacy, Al Salam University in EgyptSahar M El-Haggar, Ph D, Principal investigator, Clinical Pharmacy Department, Faculty of Pharmacy, Tanta UniversityMaryan W Fahmi, Ph D, Principal investigator, Medical oncology unit, Internal medicine Department, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387330
- Sponsor's protocol ID
- 9093595
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sonoyama J, Matsumura I, Ezoe S, Satoh Y, Zhang X, Kataoka Y, Takai E, Mizuki M, Machii T, Wakao H, Kanakura Y. Functional cooperation among Ras, STAT5, and phosphatidylinositol 3-kinase is required for full oncogenic activities of BCR/ABL in K562 cells. J Biol Chem. 2002 Mar 8;277(10):8076-82. doi: 10.1074/jbc.M111501200. Epub 2002 Jan 4.
PubMed 11779872Krause DS, Lazarides K, Lewis JB, von Andrian UH, Van Etten RA. Selectins and their ligands are required for homing and engraftment of BCR-ABL1+ leukemic stem cells in the bone marrow niche. Blood. 2014 Feb 27;123(9):1361-71. doi: 10.1182/blood-2013-11-538694. Epub 2014 Jan 6.
PubMed 24394666Sopper S, Mustjoki S, White D, Hughes T, Valent P, Burchert A, Gjertsen BT, Gastl G, Baldauf M, Trajanoski Z, Giles F, Hochhaus A, Ernst T, Schenk T, Janssen JJ, Ossenkoppele GJ, Porkka K, Wolf D. Reduced CD62L Expression on T Cells and Increased Soluble CD62L Levels Predict Molecular Response to Tyrosine Kinase Inhibitor Therapy in Early Chronic-Phase Chronic Myelogenous Leukemia. J Clin Oncol. 2017 Jan 10;35(2):175-184. doi: 10.1200/JCO.2016.67.0893. Epub 2016 Nov 7.
PubMed 28056193Podhajcer OL, Benedetti L, Girotti MR, Prada F, Salvatierra E, Llera AS. The role of the matricellular protein SPARC in the dynamic interaction between the tumor and the host. Cancer Metastasis Rev. 2008 Sep;27(3):523-37. doi: 10.1007/s10555-008-9135-x.
PubMed 18459035
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Soluble L-selectin (sCD62L) and Secreted Protein Acidic Rich in Cysteine in Chronic Myeloid Leukemia Patients Treated by Imatinib
- ClinicalTrials.gov ID
- NCT05387330
- Acronym / sponsor ID
- 9093595
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Soluble L-selectin, sCD62L, SPARC, Imatinib, CML
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 24 May 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.
This study aims to monitor the levels of soluble L-selectin (sCD62L) and secreted protein acidic rich in cysteine (SPARC) in chronic phase chronic myeloid leukemia (CP-CML) patients at baseline and after three and six months of imatinib therapy and evaluated the effect of imatinib on their levels and correlated their levels to clinical and laboratory parameters.
Detailed description
Chronic myelogenous leukemia (CML) is a clonal myeloproliferative disorder characterized by the reciprocal t (9:22) chromosomal translocation. This rearrangement produces abnormal chromosome called Philadelphia chromosome carrying the chimeric BCR-ABL oncoprotein which encodes for tyrosine kinase (TK). The Break Point Cluster Region- Abelson (BCR-ABL) fusion oncoprotein activates the various downstream signaling pathways causing reduced hematopoietic cell differentiation, decreased apoptosis, enhance proliferation and survival of leukemic cells. CML remains incurable for the most part, and only allogeneic hematopoietic stem cell transplantation can eradicate and cure CML. This is probably because quiescent leukemic stem cells are resistant to tyrosine kinase inhibitors (TKIs).
Imatinib (IM) was the first tyrosine kinase inhibitor to receive approval by the Food and Drug Administration for the treatment of patients with CML-CP. It acts via competitive inhibition at the ATP - binding site of the BCR-ABL protein, which results in the inhibition of phosphorylation of proteins involved in signal transduction. It inhibits the BCR-ABL kinase.
L-selectin is a glycoprotein which is one of three members in a family of cell adhesion molecules called selectins. L-selectin is expressed on most leukocytes and it appears to play an important role in the early stages of leukocyte-endothelial cell interaction. L-selectin is a critical molecule for the leukocyte-endothelial cell interaction that results in migration of naïve T-cells into peripheral lymph nodes and inflammatory locales such as: tumor microenvironment.
Secreted Protein, Acidic Rich in Cysteine (SPARC) is a multi-functional matricellular glycoprotein with growth inhibitory and anti-angiogenic activity in some cell types. This protein has counter adhesive properties, has effects on cell shape, immune surveillance, angiogenesis and inhibits cell proliferation. SPARC is multifunctional calcium binding matricellular glycoprotein, participates in tissue remodeling, morphogenesis and bone mineralization and is secreted by different types of cells such as: osteoblasts, fibroblasts and endothelial cells. SPARC binds Vascular Endothelial Growth Factor (VEGF), preventing VEGF induced tyrosine phosphorylation of VEGFR1 and antagonizing its pro-angiogenic effects. The role of SPARC in tumor genesis appears to be cell-type specific due to its diverse function in given microenvironment.
sCD62L and SPARC analyzed using commercially available ELISA kit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP-CML patients | – | Diagnostic Test: ELISA kitTwenty five newly diagnosed CP-CML patients. Plasma sCD62L and serum SPARC levels were measured using commercially available ELISA kits |
| Control | – | Diagnostic Test: ELISA kitTen matched controls were enrolled. Plasma sCD62L and serum SPARC levels were measured using commercially available ELISA kits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed CP-CML patients were invited to be enrolled in this study. Patients were diagnosed according to ELN guidelines. Full patient history taken and proper information sheets completed for all participants.
Key inclusion criteria (3 listed)
- Both sexes.
- Newly diagnosed patient with chronic phase, Philadelphia chromosome positive (Ph+) CML.
- Age ≥ 18 years.
Key exclusion criteria (6 listed)
- Patients in blastic or accelerated phase of chronic myeloid leukemia.
- Previous treatment with Imatinib.
- Pregnancy and lactation.
- Severe hepatic dysfunction.
- Kidney dysfunction.
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 |
|---|---|---|
| ELISA kitSandwich ELISA kit for the accurate quantitative detection of sCD62L and SPARC in human plasma and serum samples. | Diagnostic test | CP-CML patients, Control |
Primary outcome
Dynamic changes of sCD62L and SPARC levels in CP-CML patients during imatinib treatment
Time frame: Baseline and after three and six months of treatment
Monitoring the changes in sCD62L and SPARC levels at baseline and after three and six months of imatinib treatment
1 secondary outcome
Correlations of sCD62L or SPARC levels with laboratory and clinical parameters
Time frame: Baseline and after three and six months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Background: PubMed 11779872Sonoyama J, Matsumura I, Ezoe S, Satoh Y, Zhang X, Kataoka Y, Takai E, Mizuki M, Machii T, Wakao H, Kanakura Y. Functional cooperation among Ras, STAT5, and phosphatidylinositol 3-kinase is required for full oncogenic activities of BCR/ABL in K562 cells. J Biol Chem. 2002 Mar 8;277(10):8076-82. doi: 10.1074/jbc.M111501200. Epub 2002 Jan 4.
- Background: PubMed 24394666Krause DS, Lazarides K, Lewis JB, von Andrian UH, Van Etten RA. Selectins and their ligands are required for homing and engraftment of BCR-ABL1+ leukemic stem cells in the bone marrow niche. Blood. 2014 Feb 27;123(9):1361-71. doi: 10.1182/blood-2013-11-538694. Epub 2014 Jan 6.
- Background: PubMed 28056193Sopper S, Mustjoki S, White D, Hughes T, Valent P, Burchert A, Gjertsen BT, Gastl G, Baldauf M, Trajanoski Z, Giles F, Hochhaus A, Ernst T, Schenk T, Janssen JJ, Ossenkoppele GJ, Porkka K, Wolf D. Reduced CD62L Expression on T Cells and Increased Soluble CD62L Levels Predict Molecular Response to Tyrosine Kinase Inhibitor Therapy in Early Chronic-Phase Chronic Myelogenous Leukemia. J Clin Oncol. 2017 Jan 10;35(2):175-184. doi: 10.1200/JCO.2016.67.0893. Epub 2016 Nov 7.
- Background: PubMed 18459035Podhajcer OL, Benedetti L, Girotti MR, Prada F, Salvatierra E, Llera AS. The role of the matricellular protein SPARC in the dynamic interaction between the tumor and the host. Cancer Metastasis Rev. 2008 Sep;27(3):523-37. doi: 10.1007/s10555-008-9135-x.
- 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.
Mahmoud M Elkholy, Bachelor principal investigator
Clinical Pharmacy Department, Faculty of Pharmacy, Al Salam University in Egypt
Sahar M El-Haggar, Ph D principal investigator
Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University
Maryan W Fahmi, Ph D principal investigator
Medical oncology unit, Internal medicine Department, Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Tanta University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dynamic changes of sCD62L and SPARC levels in CP-CML patients during imatinib treatment (time frame: Baseline and after three and six months of treatment). 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 NCT05387330, which also lists 4 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 24 May 2022.