Clinical trial NCT01833884: Kinetic of Cytokines Decrease and Hodgkin Lymphoma Prognostic
Official title: Hodgkin's Lymphoma: Prognostic Value of the Kinetic of Decrease of 5 Cytokines Concentration During Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin's Disease
Keywords: Hodgkin Lymphoma, Adult
Cytokines
TARC
IL-6
IL1-RA
sCD30
TNFR1
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 90 days after end of treatment
Secondary outcomes:
measure: Correlation between the decrease of cytokines plasma levels and event-free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: CENTRE HENRI BECQUEREL-Rouen
name: Aspasia STAMATOULLAS, MD
role: PRINCIPAL_INVESTIGATOR
References: