NCT02069639

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

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, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

February 14, 2014

Last Update Submit

February 20, 2014

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The correlation between TARC levels and PET results after alloSCT

    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)

Study Arms (1)

no treatment

Other: no treatment

Interventions

no treatmentOTHER
no treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 24, 2014

Study Start

November 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 24, 2014

Record last verified: 2014-02

Locations

IT(1)