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.
Full Title of Study: “Hodgkin’s Lymphoma: Prognostic Value of the Kinetic of Decrease of 5 Cytokines Concentration During Treatment”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: May 2016
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.
- 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)
Arms, Groups and Cohorts
- Other: Single arm
- 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)
Clinical Trial Outcome Measures
- 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
- Time Frame: 90 days after end of treatment
- 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
- Correlation between the decrease of cytokines plasma levels and event-free survival
- Time Frame: 3 years
- Evaluation of correlation between the decrease of cytokines plasma levels and event-free survival after 3 years of follow-up
Participating in This Clinical Trial
- 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
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Centre Henri Becquerel
- Provider of Information About this Clinical Study
- Overall Official(s)
- Aspasia STAMATOULLAS, MD, Principal Investigator, CENTRE HENRI BECQUEREL-Rouen
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