NCT04818619

Brief Summary

To expresse TIGIT in NK Cells in Patients with Chronic Myeloid 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
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

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

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 24, 2021

Last Update Submit

March 25, 2021

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • TIGIT expression frequency on NK cells

    In this study, we will assay the TIGIT expression frequency on NK cells in the peripheral blood of CML patients

    18 month

Study Arms (2)

chronic myeloid leukemia patients

Diagnostic Test: flow cytometry test

Healthy individuals

Diagnostic Test: flow cytometry test

Interventions

flow cytometry testDIAGNOSTIC_TEST

Blood samples will be stained with TIGIT by flow cytometry test

Healthy individualschronic myeloid leukemia patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the participants will be divided into 2 groups , 40 CML patients and 25 healthy individuals .

You may qualify if:

  • CML patients
  • Healthy individuals

You may not qualify if:

  • Patients who have current or recent acute infection
  • Patients who have autoimmune disease
  • Patients who have diabetes mellitus disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Faderl S, Talpaz M, Estrov Z, O'Brien S, Kurzrock R, Kantarjian HM. The biology of chronic myeloid leukemia. N Engl J Med. 1999 Jul 15;341(3):164-72. doi: 10.1056/NEJM199907153410306. No abstract available.

    PMID: 10403855BACKGROUND

  • O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ; IRIS Investigators. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003 Mar 13;348(11):994-1004. doi: 10.1056/NEJMoa022457.

    PMID: 12637609BACKGROUND

  • Heaney NB, Holyoake TL. Therapeutic targets in chronic myeloid leukaemia. Hematol Oncol. 2007 Jun;25(2):66-75. doi: 10.1002/hon.813.

    PMID: 17441215BACKGROUND

  • Lee HR, Baek KH. Role of natural killer cells for immunotherapy in chronic myeloid leukemia (Review). Oncol Rep. 2019 May;41(5):2625-2635. doi: 10.3892/or.2019.7059. Epub 2019 Mar 13.

    PMID: 30896812BACKGROUND

  • Carlsten M, Jaras M. Natural Killer Cells in Myeloid Malignancies: Immune Surveillance, NK Cell Dysfunction, and Pharmacological Opportunities to Bolster the Endogenous NK Cells. Front Immunol. 2019 Oct 11;10:2357. doi: 10.3389/fimmu.2019.02357. eCollection 2019.

    PMID: 31681270BACKGROUND

  • Pizzolo G, Trentin L, Vinante F, Agostini C, Zambello R, Masciarelli M, Feruglio C, Dazzi F, Todeschini G, Chilosi M, et al. Natural killer cell function and lymphoid subpopulations in acute non-lymphoblastic leukaemia in complete remission. Br J Cancer. 1988 Sep;58(3):368-72. doi: 10.1038/bjc.1988.221.

    PMID: 3179190BACKGROUND

  • Kiladjian JJ, Bourgeois E, Lobe I, Braun T, Visentin G, Bourhis JH, Fenaux P, Chouaib S, Caignard A. Cytolytic function and survival of natural killer cells are severely altered in myelodysplastic syndromes. Leukemia. 2006 Mar;20(3):463-70. doi: 10.1038/sj.leu.2404080.

    PMID: 16408099BACKGROUND

  • Hughes A, Clarson J, Tang C, Vidovic L, White DL, Hughes TP, Yong AS. CML patients with deep molecular responses to TKI have restored immune effectors and decreased PD-1 and immune suppressors. Blood. 2017 Mar 2;129(9):1166-1176. doi: 10.1182/blood-2016-10-745992. Epub 2017 Jan 3.

    PMID: 28049640BACKGROUND

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

Central Study Contacts

Ola Abdelkarem, M.B.B.Ch

CONTACT

00201066088250olaabdelkarem1994@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical pathologist

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

December 1, 2022

Last Updated

March 29, 2021

Record last verified: 2021-03