Skip to main content
OpenTrials
Completed

NCT Number: NCT01833884

Kinetic of Cytokines Decrease and Hodgkin Lymphoma Prognostic

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hodgkin's Disease Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel

Rouen, 76000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of blood specimen

Other

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: CYTOKINES-LH

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2013
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.