Extranodal NHLs can arise from a variety of anatomical districts. Oncologists who may be interested in taking part in a specific extranodal lymphoma study, can look at IELSG ongoing trials. Participation is open to worldwide institutions.
All protocols and CRFs will be provided upon request to ielsg@ticino.com.
Data collection from each study will be centralised at the IELSG Trials Coordination Centre.



IELSG 37		 A randomized, open-label, multicentre, two-arm phase III comparative study assessing the role of involved mediastinal radiotherapy after Rituximab containing chemotherapy regimens to patients with newly diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)

(M. Martelli, A.J. Davies, M. Gospodarowicz, E. Zucca)

The aim of the trial is to evaluate the possibility to spare the radiotherapy in PMBCL patients, who have become “PET-negative” after a combined R-chemotherapy.

Protocol will be provided upon request to ielsg@ticino.com
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IELSG 36		 BRISMA - Bendamustine and Rituximab for the treatment of Splenic Marginal Zone Lymphoma - A IELSG phase II prospective study

(E. Iannitto, C. Thieblemont, C. Montalban)

Objective of the trial is to evaluate the safety and the efficacy of R-Bendamustine in symptomatic patients with Splenic Marginal Zone Lymphoma not eligible or not willing to undergo splenectomy.

Protocol will be provided upon request to ielsg@ticino.com
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IELSG 35		 A retrospective international study of primary extranodal lymphoma of female genital tract
(G. Martinelli, G. Ryan)
26 patients

This retrospective analysis aims to provide an overview on this rare neoplasm to better understand clinical and histological characteristics and define diagnostic and treatment modalities, response rate and prognosis.

Protocol will be provided upon request to ielsg@ticino.com
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IELSG 34		 A Multicenter Phase II study to evaluate the clinical activity and the safety profile of everolimus (RAD001) in marginal zone B-cell lymphomas (MZL)
(E. Zucca, A. Conconi)
Open only at some selected centres
23 patients
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IELSG 33		 A Prospective observational study of newly diagnosed diffuse large B cell primary breast lymphomas treated with R-CHOP with or without radiotherapy
(K. Ganjoo, G. Ryan, G. Martinelli)
1 patient

This is an observational study for patients with stage I or II promary breast DLBCL. Patients would need to sign a consent form to allow their data to be used in this study. There will be no therapeutic decisions made in this study. Only patients who are treated with RCHOP-14 or RCHOP-21 for 6 cycles will be qualified. Involved field radiotherapy is recommeded (accordino to the results of a previous IELSG retrospective trial) but not mandatory and will be given at the discretion of the treating physician. The primary endpoint for this study is to determine the local relapse rate and compare to historical controls where rituximab was not given. In addition, the response rate, rate of CNS relapse, and PFS will be evaluated.

Protocol will be provided upon request to ielsg@ticino.com
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IELSG 32		 Randomized phase II trial on primary chemotherapy with high-dose methotrexate and high-dose cytarabine with or without thiotepa, and with or without rituximab, followed by brain irradiation vs. high-dose chemotherapy supported by autologous stem cells transplantation for immunocompetent patients with newly diagnosed primary CNS lymphoma
(Study chair: A. Ferreri, G. Illerhaus)
68 patients

In primary central nervous system lymphomas (PCNSL) the difficulties in obtaining the same promising results observed in systemic NHL constitute a relevant clinical challenge. Indeed, several questions regarding the optimum therapeutic management of patients with newly diagnosed PCNSL remain open.
This study will compare the activity of three different chemotherapy combinations with high-dose methotrexate (HD-MTX) + high-dose cytarabine (HD-araC), HD-MTX + HD-araC + rituximab and HD-MTX + HD-araC + rituximab + thiotepa. Moreover, the trial will test in a randomised design the efficacy of two consolidation strategies: conventional whole-brain radiotherapy (WBRT) vs. high-dose chemotherapy supported by autologous stem cell transplantation (HDC + ASCT).

Protocol will be provided upon request to ielsg@ticino.com
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IELSG 31		 A retrospective international study of primary extranodal follicular lymphoma
(Study chair: E. Zucca, Bellinzona, Switzerland, B. Pro, Houston, USA, M. Federico, Modena, Italy, A. Guillermo Lopez, Barcelona, Spain)
233 patients

Extranodal presentation of FL constitutes a very rare condition. A peculiar extranodal histological variant is described by the WHO classification, the primary cutaneous FL, which is now considered a separate entity. Other uncommon extranodal sites of FL have been described but their rarity and the very scanty literature reports prompted the IELSG to launch this international multicentric study to collect data regarding the specific clinical and biological features of this group of indolent lymphomas, with the aim to clarify the relationship between the nodal FL and those primarily presenting at non-cutaneous extranodal sites.

Protocol will be provided upon request to ielsg@ticino.com
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IELSG 30		 A phase II study of R-CHOP with intensive CNS prophylaxis and scrotal irradiation in patients with primary testicular diffuse large B-cell lymphoma
(Study chair: U. Vitolo, E. Zucca)
16 patients

To assess the feasibility, activity and safety of a therapeutic program in which patients with testicular large cell lymphoma receive state-of-the-art chemoimmunotherapy (R-CHOP regimen) plus both intrathecal (with liposomal cytarabine) and systemic CNS prophylaxis (with intermediate-dose methotrexate), followed by locoregional radiotherapy.

Protocol will be provided upon request to ielsg@ticino.com
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IELSG 28		 A retrospective international clinico-pathological study of primary extranodal marginal zone lymphoma of the lung (BALT-lymphoma)
(Principal investigators: Giovanni Martinelli, Milan, Italy, P.L. Zinzani, Bologna, Italy)
215 patients

The study aims to answer several questions that have not been adequately addressed by the published literature on this relatively uncommon lymphoma.
A database with clinical characteristics, histological features, diagnostic and treatment modalities, response to treatment and survival information on BALT-lymphoma patients will be set up and the paraffin-embedded material prepared at the time of initial diagnosis will be used to prepare tissue micro-arrays.
The correlation between the histological and biological features (immunophenotype and immunohistochemistry, molecular biology) and the clinical patterns (symptoms, stage, response to treatment, survival) will be studied as well as the genetic and molecular characteristics of BALT lymphomas that will be analysed using the Polymerase Chain Reaction and Fluorescent In Situ Hybridization techniques.
Hopefully, the study will improve our knowledge on the genetic and clinico-pathological features of these lymphomas. Hypothesis on treatment strategies might possibly be generated (based on the study results) that later could be evaluated in prospective studies.

Protocol and CRFs may be downloaded

ASH 2010: oral and poster presentation
ASH 2011: oral presentation
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IELSG 17		 Multi-institutional retrospective analysis of intravascular lymphomatosis
(Chairmen: A. Ferreri and M. Ponzoni, Milan, Italy)
68 patients

Intravascular or angiotropic lymphoma (IVL) is a rare albeit described entity characterized by a neoplastic growth predominantely within the blood vessel lumina. Diagnosis is often made accidentally during surgical interventions so that a higher incidence should considered. Isolated case-reports suggest an aggressive behaviour but no adequate series are available and no guidelines exhist for the optimal therapeutic management.
The IELSG reviewed clinical and pathological characteristics of 17 HIV-negative patients. Preliminary results confirm an aggressive and usually disseminated presentation with brain and skin being the most frequently involved organs, advanced age of patients with poor performance status and elevated LDH. Despite survival is poor chemotherapy can obtain objective responses and produce prolonged intervals of remission.
The study is still open for patients' registration.

Synopsis and CRFs may be downloaded.

Lugano Conference on Malignant Lymphoma 2002: oral presentation
Original article: Annals of Oncology, 2004; 15(8): 1215-1221
Original article: British Journal of Hematology, 2004; 127(2): 173-83
EHA 2006: poster presentation
Original article: Haematologica, 2007; 92(04): 486-492
Original article: Journal of Clinical Oncology 2007 Jul20;25(21):3168-73
Lugano Conference on Malignant Lymphoma 2008: poster presentation
Lugano Conference on Malignant Lymphoma 2008: poster presentation
Original article: British Journal of Hematology, 2008; 143(2): 253-257
Correspondence: Journal of Clinical Oncology 2008 October