TARC After alloSCT in Hodgkin's Lymphoma

Hodgkin's Lymphoma Patients Who Underwent an Allogeneic Stem Cell Transplantation Clinical Trial

— TARC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069639
• Other study ID #: TARC
• Status: Completed
• Phase: N/A
• First received: February 14, 2014
• Last updated: February 20, 2014
• Start date: November 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma Patients Who Underwent an Allogeneic Stem Cell Transplantation
• Lymphoma

Intervention

Other:
• no treatment

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between disease status and serum TARC level	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	No
Secondary	The correlation between TARC levels and PET results after alloSCT	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)	No