Clinical trial NCT01545544: Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)
Official title: Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis C
Keywords: B-Cell Non Hodgkin Lymphomas
Hepatitis C
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2012-03-06
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with HCV infection with positive viral load and a B-cell NHL.

Brief summary: An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study.

Detailed description: Main objectives are:

* Description of the clinical and histological characteristics, treatment and evolution of these NHL.
* Study their physiopathology by immunological, virologic and molecular studies.

The study included prospective or retrospective patients with B- Cell Non-Hodgkin lymphomas (NHL) associated with chronic hepatitis C. The patients are diagnosed or in remission of lymphoma, in relapse or failure of treatments.

The enrolment period is 6 years and the total study lasts 8 years.

* "Prospective patients" are followed every 6 months during one year, and all the years during 2 or 5 years.
* "Retropective patients" are followed all the years during 2 or 5 years. At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.

The enrollment is estimated at 140 patients.

Eligibility criteria: Inclusion Criteria:

* Patients with evolving NHL whatever its histological type
* At diagnosis or relapse or failure previous treatments stopped over 3 months
* Patients with HCV infection with positive quantitative viral load
* 18 years or more of age
* Life expectancy greater than 6 months
* Signed and informed consent
* Benefit from social security

Exclusion Criteria:

* Active uncontrolled infection (out hepatitis C)
* HIV (Human immunodeficiency virus) infection
* Severe psychiatric history

Primary outcomes:
measure: presentation of NHL and HCV infection, and treatments of NHL and HCV infection
timeFrame: at the first visit (Day 0)
Secondary outcomes:
measure: Summary of intercurrents biological and clinical events
timeFrame: Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60
measure: virological response
timeFrame: Month 60
measure: haematological response
timeFrame: Month 60
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker
Study officials:
affiliation: Hôpital Necker (Paris 15è), Service d'hématologie
name: Olivier HERMINE, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité INSERM 707
name: Fabrice CARRAT, PU-PH
role: STUDY_CHAIR
References:
citation: Michot JM, Canioni D, Driss H, Alric L, Cacoub P, Suarez F, Sibon D, Thieblemont C, Dupuis J, Terrier B, Feray C, Tilly H, Pol S, Leblond V, Settegrana C, Rabiega P, Barthe Y, Hendel-Chavez H, Nguyen-Khac F, Merle-Beral H, Berger F, Molina T, Charlotte F, Carrat F, Davi F, Hermine O, Besson C; ANRS HC-13 Lympho-C Study Group. Antiviral therapy is associated with a better survival in patients with hepatitis C virus and B-cell non-Hodgkin lymphomas, ANRS HC-13 lympho-C study. Am J Hematol. 2015 Mar;90(3):197-203. doi: 10.1002/ajh.23889. Epub 2014 Nov 24.