Kinetic of Cytokines Decrease and Hodgkin Lymphoma Prognostic

Hodgkin's Disease Clinical Trial

— CYTOKINES-LH  

Official title:

Hodgkin's Lymphoma: Prognostic Value of the Kinetic of Decrease of 5 Cytokines Concentration During Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833884
• Other study ID #: CHB 09-02
• Secondary ID: RCB : 2009-A0111
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: July 19, 2017
• Start date: April 2010
• Est. completion date: June 2016

Study information

• Verified date: July 2017
• Source: Centre Henri Becquerel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

More than 90% of patients with Hodgkin lymphoma (HL) can recover thanks to conventional polychemotherapy regimens - ABVD or BEACOPP - with or without radiotherapy. Nevertheless, some patients relapse and others are resistant to any treatment. These patients represent 2-5% of stage I / II and 5-10% of disseminated stages. The usual prognostic index based on clinical and biological data (supradiaphragmatic HL: EORTC and advanced HL International Prognostic Score) cannot always detect patients at risk.

New prognostic factors are required to screen out these high risk patients. Among available biological factors, we will retain the cytokines secreted by tumor cells and cells from the environment.

Indeed, the prognostic value of plasma cytokines levels and their soluble receptors has recently been described by at least two teams. Olivier CASASNOVAS set up a prognostic index based on quantities of IL-1 RA, IL-6, sCD30 and TNFR1 at diagnosis,and the V. Diehl team published the prognostic value of the decrease of TARC (CC Thymus and Activation-related chemokine).

In daily practice, the early assessment of response by PET CT-scan is now an undeniable prognostic factor. Early identification of no-response or relapse is, in fact, based on clinical and imaging (PET-CT scan).

We propose to evaluate the decrease of cytokines concentration with a prognostic value (TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early follow-up. The dosage of these cytokines will be paired with radiological assessments.

A correlation between the decrease of cytokines plasma levels overtime and event-free survival will be searched afterwards.

Description:

To evaluate the decrease of cytokines concentration with a prognostic value as markers of response, the dosage of TARC, IL-6, IL1-RA, sCD30 and TNFR1 will be performed during treatment at :diagnosis, cycle 1 day 15, cycle 2 Day 1, cycle 3 Day 1, Day 1 of consolidation (Cycle 5 day 1 or before radiotherapy) and evaluation of end of treatment.

an early follow-up with a dosage of cytokines will be performed 3 months after the end of treatment.

An evaluation for Event Free Survival will be done at 3 years from diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hodgkin Lymphoma diagnosis

• I-II or III-IV Stages

• untreated Patient (including corticosteroids)

• Patient treated and followed exclusively in center Henri Becquerel

• Informed Consent signed

Exclusion Criteria:

• psychological, social or family conditions not allowing a suitable follow-up for study

• Mental deficiency not allowing the good understanding of study procedures

• positive HIV serology

• positive B or C Hepatitis serology

• Pregnant or lactating

• Patient registered with a social security scheme or in an equivalent situation

• Patient in a period of exclusion on another biomedical study.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Lymphoma

Intervention

Other:
• Collection of blood specimen
Collection of blood specimen for Cytokines dosing scheduled before , during and after treatment of Hodgkin's lymphoma (last collection date about 90 days after the end of treatment)

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of cytokines concentration TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early follow-up in Hodgkin's disease	evaluate the decrease of cytokines concentration with a prognostic value (TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment (At Cycle 1 Day 15 of chemotherapy,Cycle 2 Day 1, cycle 3 Day 1, Cycle 5 Day 1 or Day 1 of Radiotherapy, 1 month after the end of treatment) , and during early follow-up (3 months after the end of treatment) in patients with Hodgkin's disease	90 days after end of treatment
Secondary	Correlation between the decrease of cytokines plasma levels and event-free survival	Evaluation of correlation between the decrease of cytokines plasma levels and event-free survival after 3 years of follow-up	3 years