NCT03150849

Brief Summary

Chronic lymphocytic leukemia is the most common type of chronic leukemia, accounting for approximately 40% of all leukemias and mainly affecting older individuals. As it has a highly variable clinical course, identification of molecular and biological prognostic markers has provided new insights into the risk stratification of patients with chronic lymphocytic leukemia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

May 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 7, 2017

Last Update Submit

May 11, 2017

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • The level of C-X-C Chemokine Receptor 4 in chronic lymphocytic leukemia patient and healthy individual

    the level of C-X-C Chemokine Receptor 4 marker assessed by flowcytometry in a blood sample

    2 years

Study Arms (2)

patient group

patient with chronic lymphocytic leukemia

Diagnostic Test: C-X-C Chemokine Receptor 4

control group

healthy control group

Diagnostic Test: C-X-C Chemokine Receptor 4

Interventions

C-X-C Chemokine Receptor 4DIAGNOSTIC_TEST

marker assessed by flowcytometry in a blood sample

control grouppatient group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

From Hematology clinic with chronic lynphocytic leukemia

You may qualify if:

  • All patients are newly diagnosed as chronic lymphocytic leukemia

You may not qualify if:

  • Patients with associated malignancies.
  • Chronic lymphocytic leukemia patients on chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Palmesino E, Moepps B, Gierschik P, Thelen M. Differences in CXCR4-mediated signaling in B cells. Immunobiology. 2006;211(5):377-89. doi: 10.1016/j.imbio.2005.12.003. Epub 2006 Apr 18.

    PMID: 16716807BACKGROUND

  • Burger JA, Peled A. CXCR4 antagonists: targeting the microenvironment in leukemia and other cancers. Leukemia. 2009 Jan;23(1):43-52. doi: 10.1038/leu.2008.299. Epub 2008 Nov 6.

    PMID: 18987663BACKGROUND

  • Barretina J, Junca J, Llano A, Gutierrez A, Flores A, Blanco J, Clotet B, Este JA. CXCR4 and SDF-1 expression in B-cell chronic lymphocytic leukemia and stage of the disease. Ann Hematol. 2003 Aug;82(8):500-505. doi: 10.1007/s00277-003-0679-0. Epub 2003 May 29.

    PMID: 12783211BACKGROUND

  • Marchese A. Endocytic trafficking of chemokine receptors. Curr Opin Cell Biol. 2014 Apr;27:72-7. doi: 10.1016/j.ceb.2013.11.011. Epub 2013 Dec 14.

    PMID: 24680433BACKGROUND

  • Domanska UM, Kruizinga RC, Nagengast WB, Timmer-Bosscha H, Huls G, de Vries EG, Walenkamp AM. A review on CXCR4/CXCL12 axis in oncology: no place to hide. Eur J Cancer. 2013 Jan;49(1):219-30. doi: 10.1016/j.ejca.2012.05.005. Epub 2012 Jun 9.

    PMID: 22683307BACKGROUND

  • Vlad A, Deglesne PA, Letestu R, Saint-Georges S, Chevallier N, Baran-Marszak F, Varin-Blank N, Ajchenbaum-Cymbalista F, Ledoux D. Down-regulation of CXCR4 and CD62L in chronic lymphocytic leukemia cells is triggered by B-cell receptor ligation and associated with progressive disease. Cancer Res. 2009 Aug 15;69(16):6387-95. doi: 10.1158/0008-5472.CAN-08-4750. Epub 2009 Aug 4.

    PMID: 19654311BACKGROUND

  • Li SH, Dong WC, Fan L, Wang GS. Suppression of chronic lymphocytic leukemia progression by CXCR4 inhibitor WZ811. Am J Transl Res. 2016 Sep 15;8(9):3812-3821. eCollection 2016.

    PMID: 27725861BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Eman mohamed salah, MD

CONTACT

01028030966Emansalah.eldin@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 12, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share