TARC After alloSCT in Hodgkin's Lymphoma (TARC)

February 20, 2014 updated by: Paolo Corradini, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Serum Thymus and Activation-regulated Chemokine (TARC) Level Monitoring May Predict Disease Relapse Detected by PET Scan After Reduced Intensity Allogeneic Stem Cell Transplantation in Hodgkin's Lymphoma Patients

Relapsed and refractory Hodgkin's lymphoma (HL) patients may experience long-term survival after allogeneic transplant (alloSCT), but disease recurrence represents the main cause of treatment failure. PET (positron-emission tomography) -positive patients after alloSCT have a dismal outcome. Serum TARC (thymus and activation-regulated chemokine) is produced by Reed-Sternberg cells and may be a marker of disease. Our study was aimed at assessing whether TARC levels after alloSCT were correlated to disease status and whether TARC monitoring could increase the ability to predict relapse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study included 22 consecutive Hodgkin's lymphoma patients who underwent an alloSCT at Fondazione IRCCS Istituto Nazionale dei Tumori and who were monitored by PET and TARC before and after alloSCT.

Description

Inclusion Criteria:

  • Hodgkin's lymphoma patients who underwent an alloSCT at Fondazione IRCCS Istituto Nazionale dei Tumori and who were monitored by PET and TARC before and after alloSCT from 2009

Exclusion Criteria:

  • Hodgkin's lymphoma patients who underwent an alloSCT who were not monitored by PET or/and TARC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no treatment
Other: no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between disease status and serum TARC level
Time Frame: One year after transplant
Serum TARC level was measured before alloSCT in Hodgkin's lymphoma patients and after alloSCT. The median time interval after alloSCT was 47 days. PFS was estimated at one year based on TARC value.
One year after transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between TARC levels and PET results after alloSCT
Time Frame: Before alloSCT, monthly during the first 6 months after alloSCT and every 2 months until 2 years of follow-up, then at the time of clinical check-up (usually every 6 months)
We selected TARC values done on the days of PET to assess a cut-off value of TARC that was correlated to a positive or negative PET
Before alloSCT, monthly during the first 6 months after alloSCT and every 2 months until 2 years of follow-up, then at the time of clinical check-up (usually every 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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