| 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 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) 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) 3 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) 205 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) 5 patient 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 29 |
A retrospective study on primary bone marrow lymphoma (M. Rozman, A. Martínez-Pozo, C. Agostinelli, K. M. Hebeda, E. Matutes, M. Ponzoni, A. Ferreri, C. Campidelli, A. López-Guillermo, S. Pileri, E. Campo) 25 patients Lymphomas detected exclusively in the bone marrow, after excluding classically leukemic lymphomas, are rare. In order to assess whether or not primary bone marrow lymphoma (PBML) could be considered as a real entity among extranodal lymphomas, a retrospective analysis is ongoing. The definition of PBML comprised the following criteria: 1) isolated involvement of bone marrow (with or without peripheral blood) 2) no evidence of extra-marrow involvement on imaging studies 3) no evidence of splenic infiltration 4) absence of localized bone tumours 5) exclusion of lymphoma subtypes primarily affecting bone marrow, such as SLL/CLL, lymphoplasmacytic, splenic marginal zone, Burkitt's lymphoma, ALL and lymphoblastic lymphomas. For further information contact: Maria Rozman, Barcelona, Spain Maurilio Ponzoni, Milan, Italy EAHP 2008: poster presentation |
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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) 74 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 |
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 IELSG 27 |
A Clinico-pathological phase II study with translational elements to investigate the possible infective causes of MALT lymphoma of the ocular adnexa with particular reference to Chlamydia species and the effects of treatment with tetracycline (Study Chairs: Andrés J. M. Ferreri, Milan, Italy, John Radford, Manchester, UK) 48 patients The development of ocular adnexal MALT lymphoma is frequently associated with chronic conjunctivitis, a well recognised cause of which is infection by Chlamydia. Recent studies from northern Italy provided sound evidence for an association between C. psittaci infection and ocular adnexal MALT lymphoma but this finding was not confirmed by studies conducted in other geographic areas. The purpose of this novel IELSG study is to further investigate this relationship and explore the implications for treatment. This study will address the geographic variability of the association between Chlamidya psittaci infection and ocular adnexa lymphoma and will explore the utility of a first line therapy of ocular adnexal MALT lymphoma with antibiotics alone, attempting to correlate the treatment response to molecular genetic findings. Protocol will be provided upon request to ielsg@ticino.com |
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 IELSG 26 |
Clinico-pathologic study of primary mediastinal B-cell lymphoma (Clinical Trial coordinators: P.W.M. Johnson, Southampton, UK, E. Zucca, Bellinzona, Switzerland, P.L. Zinzani, Bologna, Italy, M. Martelli, Roma, Italy, A. Lopez-Guillermo, Barcelona, Spain) 113 patients This prospective multi-centre cohort study has been designed to investigate the diagnostic and prognostic utility of PET scan in primary mediastinal lymphoma. Aims of the study are the determination of response rate on PET scanning following initial chemo-immunotherapy and a systematic analysis of the phenotype and molecular characteristics of Primary Mediastinal Large B-cell Lymphoma. Patients will be enrolled on the basis of the clinical and pathologic characteristics of their lymphoma. Central review of all pathology will be carried out, with storage of fresh frozen biopsy material wherever possible. PET scans will be performed at the start of chemotherapy and at its conclusion, with central review of the images for quality control. Interim (mid-treatment) PET scans are permitted according to normal practice in each centre, but will not be reviewed centrally. Patients will receive one of the standard chemo-immunotherapy protocols currently in use for diffuse large B-cell lymphoma (i.e., R-CHOP-21, R-CHOP-14,R-MACOP-B, R-VACOP-B, R-ACVBP). Consolidation radiotherapy to the mediastinum will be carried out according to the local protocol of the treating centre. Protocol will be provided upon request to ielsg@ticino.com |
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 IELSG 19 |
Multicenter randomized trial of chlorambucil versus chlorambucil plus rituximab versus rituximab alone in extranodal marginal zone B-cell lymphoma of mucosa associated lymphoid tissue (MALT lymphoma) (Chairpersons: Emanuele Zucca, Bellinzona, Switzerland, Emilio Montserrat, Barcelona, Spain, Catherine Thieblemont, Lyon, France,Giovanni Martinelli, Milan, Italy, Peter Johnson, Southampton, UK, Italian Lymphoma Intergroup, Italy) 433 patients The aim of the study initially was to assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and to determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone. All the MALT lymphoma patients with localised disease at any site who do not respond to local therapy, the H.pylori-negative gastric lymphomas or those who failed antibiotic therapy will be eligible as well as those with disseminated or multifocal MALT lymphoma at any extranodal site. Because of the excellent and fast recruitment, after the accrual of 250 patients an amendment was introduced to add a third arm (namely, Rituximab alone). The last protocol version and CRFs will be provided upon request to ielsg@ticino.com ASH 2009: poster 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 |