Clinical trial NCT01164436: Cohort of HIV Associated Lymphomas
Official title: French Cohort of HIV Associated Lymphomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France
name: Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France
name: University Hospital, Grenoble
name: Dr Irène Joab Hôpital Paul Brousse Villejuif France
name: Dr Alex Duval Fondation Jean Dausset CEPH
name: Hopital Antoine Beclere
First posted: 2010-07-16
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The recruitment of 80 cases per year is expected. The length of inclusions is 5 years. The follow-up will be of 5 years. Clinical, pathological and biological data at diagnosis and during follow-up will be collected. This will allow characterizing the lymphoma, the HIV infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be centralized to collect cell, DNA, RNA, plasma, serum and tumour collection.

Brief summary: The incidence of lymphomas is increased among HIV infected patients. In 70 % of cases, those are Non Hodgkin's lymphomas (NHL) and Hodgkin lymphomas (HL) in 30% of cases. In France, their incidence is estimated to 100 cases per year (data from the "Base de données Hospitalière Française sur l'Infection à VIH" (FHDH)). The main mechanisms involved in lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (Epstein-Barr (EBV) and HHV8) and molecular oncogenic events. A better understanding of these different pathways, give the possibility to design specific treatments. The treatment of these lymphomas is not standardized. A prospective study of patients with HIV associated lymphoid malignancies is an innovating tool to answer epidemiological, physiopathological and therapeutic questions. We propose a prospective multicentric study of these patients.

The main objectives of this prospective study are to:

* evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV
* perform an observational study of the treatment and outcome of these patients out of the context of clinical trials,
* study the differentiation and activation of B-cell populations,
* better understand the role of specific T cell responses in the control of EBV infection,
* allow other biological studies from the ANRS group " Lymphome et VIH ".

The recruitment of 40 cases per year is expected. The length of inclusions is 7 years. The follow-up will be of 2 years. Clinical, pathological and biological data at diagnosis and during follow-up will be collected. This will allow characterizing the lymphoma, the HIV infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be centralized to collect cell, DNA, RNA, plasma, serum and tumour collections (Y.Taoufik, S Prevot\* ). To better understand the EBV infection and lymphomagenesis in HIV infection, we propose to follow the viral load and the molecular characteristics of EBV in PBMC, plasma and tumour (P.Morand\* , V.Boyer\* ), to investigate the EBV-T cell responses (G.Carcelain) and the presence and reactivation of EBV in peripheral B cells (C.Amiel\* , JC Nicolas) and in tumoral samples (M.Raphael\* , I.Joab\* ). The other mechanisms of lymphomagenesis in HIV infection will be studied by the analysis of the sub-populations of B-cells in terms of activation and differentiation (Y.Taoufik) and by the characterization of MSI tumours (A.Duval).


Eligibility criteria: Inclusion Criteria:

* Male and female patients over 18 years of age
* patients with HIV-1 or 2 infection
* with Non Hodgkin's lymphomas (NHL) or Hodgkin lymphomas (HL) in the diagnosis or in relapse
* sign an informed consent

Exclusion Criteria:

* patients who suffered from acute leukemia
* patients treated for lymphoïd blood disease
* Patients whose lymphomas treatment was stopped for less than 3 months
* unaffiliated to the social healthy security french system

Primary outcomes:
measure: Correlation between EBV viral load and plasma HIV RNA viral load and CD4 cell count in HIV-infected patients with lymphomas (LNH or LH) at the time of lymphoma diagnosis
timeFrame: 5 year
Secondary outcomes:
measure: Survival rate in HIV patients with NHL or HL
timeFrame: 5 year
measure: Progression-free survival rate in HIV patients with NHL or HL
timeFrame: 5 year
measure: Levels of EBV in tumors of HIV patients with NHL or HL
timeFrame: 5 year
measure: Levels of B cell activating cytokines in plasma of HIV patients with NHL or HL
timeFrame: 5 year
Other outcomes:
Locations:
city: Paris
country: France
facility: BESSON
Study officials:
affiliation: Service Hématologie Immunologie Biologie, Hopital Bicetre
name: Caroline BESSON
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Tenon Paris
name: Gilles Pialoux, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital St Antoine Paris
name: Marie Caroline Meyonas, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Pitiè Salpétrière
name: Christine Katlama, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Pitiè Salpétrière Paris
name: Jean Gabarre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Cochin PARIS
name: Dominique Salmon, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Cochin Paris
name: François Dreyfus, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hotel Dieu PARIS
name: Jean Paul Viard, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Corbeil Essone 91
name: Alain Devidas, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Villejuif 94
name: Emma Goldschmidt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bicêtre 94
name: Cecile Goujard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pointoise 95
name: Laurent Blum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clamart 92
name: François Boué, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Nice 06
name: Eric Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vandoeuvre les Nancy 54
name: Christine Burty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Strasbourg 67
name: Jean Marie Lang, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Caen 14
name: Renaud Verdon, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Tourcoing 59
name: Yazdan Yazdanpanah, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Besancon 25
name: Christine Drobacheff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toulouse 31
name: Bruno Marchou, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Toulouse 31
name: Corinne Couteau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bordeaux 33
name: Philippe Morlat, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Lyon 69
name: Christian Trepo, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Lyon 69
name: Hervé Ghesquières, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Marseille
name: Régis Costellos, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Pierre Bénite
name: Bertrand Coiffier, Ph
role: PRINCIPAL_INVESTIGATOR
affiliation: St Brieuc 22
name: Claude Beuscart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Roche Sur Yon 85
name: Philippe Perre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Pierre 97
name: Patrice Poubeau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes 44
name: François Raffi, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: St Etienne 42
name: Frédéric Lucht, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Nice 06
name: Nicolas Mounier, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes 35
name: Cédric Arvieux, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Pitié Salpétrière Paris
name: Serge Herson, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Lariboisière Paris
name: Jean François Bergmann, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Fort de France 97( Martinique)
name: André Cabié, PH
role: PRINCIPAL_INVESTIGATOR
References: