Clinical trial NCT01380587: Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia
Official title: Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Keywords: ALL
XCL1
Cytokines
Prognosis
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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

Detailed description: Each year approximately 256,000 children and adults around the world develop a form of leukemia, and 209,000 died from it. Recently, some studies have evaluated the relationship between the concentration of some cytokines and prognosis of acute lymphoblastic leukemia. XCL1 is a lymphotactin that belongs to a cytokine subfamily called C or γ with only one cysteine in the N-terminal residue. It has been found with significant expression of receptor mRNA XCL1 (XCR1) in T and B lymphocytes and related to hematological neoplasms. For these reasons, XCL1 could be a efficient marker of prognosis in patients with acute lymphoblastic leukemia.

Eligibility criteria: Inclusion Criteria:

Patients with newly diagnosed acute lymphoblastic leukemia .

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of patients with poor prognosis and high levels of XCL1
timeFrame: 3 months
measure: Number of patients with poor prognosis and high levels of cytokines
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose E. Gonzalez UANL
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez UANL
name: Cesar H Gutierrez Aguirre, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.