Acute Lymphoblastic LeukemiaXCL1NCT01380587
Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia
An observational study of Acute Lymphoblastic Leukemia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2010to Sep 2012
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with newly diagnosed acute lymphoblastic leukemia .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. Jose E. Gonzalez UANL
Monterrey, Nuevo León, 64460
About this study
The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.
Read the 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, XCL1, Cytokines, Prognosis
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Cesar H Gutierrez Aguirre, MD, Principal investigator, Hospital Universitario Dr. Jose E. Gonzalez UANL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380587
- Sponsor's protocol ID
- XCL1 in ALL
- Acronym
- XCL1
- Status last verified
- Aug 2013
- First submitted
- 22 Jun 2011
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11181058Taub DD, Oppenheim JJ. Chemokines, inflammation and the immune system. Ther Immunol. 1994 Aug;1(4):229-46.
PubMed 7584498Oppenheim 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.
PubMed 1910690Bazan 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.
PubMed 9024663Rollins BJ. Chemokines. Blood. 1997 Aug 1;90(3):909-28. No abstract available.
PubMed 9242519Stievano 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.
PubMed 14568926
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01380587
- Acronym / sponsor ID
- XCL1 / XCL1 in ALL
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, XCL1, Cytokines, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with newly diagnosed acute lymphoblastic leukemia .
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with poor prognosis and high levels of XCL1
Time frame: 3 months
Number of patients with high levels of XCL1, expression of its receptor and other cytokines.
Number of patients with poor prognosis and high levels of cytokines
Time frame: 3 months
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.
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 27 Aug 2013.
- Background: PubMed 11181058Huang 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.
- Background: PubMed 7584498Taub DD, Oppenheim JJ. Chemokines, inflammation and the immune system. Ther Immunol. 1994 Aug;1(4):229-46.
- Background: PubMed 1910690Oppenheim 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.
- Background: PubMed 9024663Bazan 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.
- Background: PubMed 9242519Rollins BJ. Chemokines. Blood. 1997 Aug 1;90(3):909-28. No abstract available.
- Background: PubMed 14568926Stievano 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.
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Cesar H Gutierrez Aguirre, MD principal investigator
Hospital Universitario Dr. Jose E. Gonzalez UANL
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 Acute Lymphoblastic Leukemia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 1 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 27 Aug 2013. 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 Mexico. 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?
Number of patients with poor prognosis and high levels of XCL1 (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT01380587, which also lists 6 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 27 Aug 2013.