NCT01380587

Brief Summary

The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 27, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

June 22, 2011

Last Update Submit

August 26, 2013

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALLXCL1CytokinesPrognosis

Outcome Measures

Primary Outcomes (2)

  • Number of patients with poor prognosis and high levels of XCL1

    Number of patients with high levels of XCL1, expression of its receptor and other cytokines.

    3 months

  • Number of patients with poor prognosis and high levels of cytokines

    Measurements obtained will be evaluated to assess the prognosis of patients and made correlations with the concentration of IL-1β, IL-2 and XCL1 as well as the relationship XCR1 XCL1 and in leukemic cells.

    3 months

Study Arms (1)

Acute Lymphoblastic Leukemia

We will invite patients with newly diagnosed acute lymphoblastic leukemia in the Department of Hematology, who had not received anticancer therapy and regardless the subtype and immunophenotype of the disease.

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will invite patients with newly diagnosed acute lymphoblastic leukemia , who had not received anticancer therapy and regardless the subtype and immunophenotype of the disease.

You may qualify if:

  • Patients with newly diagnosed acute lymphoblastic leukemia .

You may not qualify if:

  • Patients with prior treatment with chemotherapeutic agents.
  • Patients treated with immunosuppressants.
  • Patients under 12 months old.
  • Patients with a diagnosis or history of autoimmune diseases.
  • Patients with a diagnosis or history of immunosuppressive diseases.
  • Patients who do not agree to sign a Letter of Informed Consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Dr. Jose E. Gonzalez UANL

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (6)

  • Huang H, Li F, Cairns CM, Gordon JR, Xiang J. Neutrophils and B cells express XCR1 receptor and chemotactically respond to lymphotactin. Biochem Biophys Res Commun. 2001 Feb 23;281(2):378-82. doi: 10.1006/bbrc.2001.4363.

    PMID: 11181058BACKGROUND

  • Taub DD, Oppenheim JJ. Chemokines, inflammation and the immune system. Ther Immunol. 1994 Aug;1(4):229-46.

    PMID: 7584498BACKGROUND

  • Oppenheim JJ, Zachariae CO, Mukaida N, Matsushima K. Properties of the novel proinflammatory supergene "intercrine" cytokine family. Annu Rev Immunol. 1991;9:617-48. doi: 10.1146/annurev.iy.09.040191.003153.

    PMID: 1910690BACKGROUND

  • Bazan JF, Bacon KB, Hardiman G, Wang W, Soo K, Rossi D, Greaves DR, Zlotnik A, Schall TJ. A new class of membrane-bound chemokine with a CX3C motif. Nature. 1997 Feb 13;385(6617):640-4. doi: 10.1038/385640a0.

    PMID: 9024663BACKGROUND

  • Rollins BJ. Chemokines. Blood. 1997 Aug 1;90(3):909-28. No abstract available.

    PMID: 9242519BACKGROUND

  • Stievano L, Tosello V, Marcato N, Rosato A, Sebelin A, Chieco-Bianchi L, Amadori A. CD8+ alpha beta+ T cells that lack surface CD5 antigen expression are a major lymphotactin (XCL1) source in peripheral blood lymphocytes. J Immunol. 2003 Nov 1;171(9):4528-38. doi: 10.4049/jimmunol.171.9.4528.

    PMID: 14568926BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells, blasts

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Cesar H Gutierrez Aguirre, MD

    Hospital Universitario Dr. Jose E. Gonzalez UANL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 27, 2011

Study Start

November 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 27, 2013

Record last verified: 2013-08

Locations

ME(1)