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Studies

Extranodal NHLs can arise from a variety of anatomical districts. Participation is open to worldwide institutions.

For further information about the clinical trials, please contact us.

Ongoing Trials

  • IELSG47 Study
    IELSG47 MALIBU trial – Phase II study of combination ibrutinib and rituximab in untreated marginal zone lymphomas
    Participants required: 175 (130 patients with EMZL + 30 SMZL and 15 NMZL)
    Investigator responsible(s): C.Thieblemont, A. Conconi
    Objective(s): Aim of the study is to assess the safety and efficacy of the combination of rituximab and ibrutinib in EMZL patients and to explore its activity in SMZL and NMZL as exploratory subset.

  • IELSG46 Study
    IELSG46 Integrated molecular and clinical profiling to optimize outcome prediction in Splenic Marginal Zone Lymphoma
    Participants required: Biological samples of at least 300 subjects
    Investigator responsible(s): D. Rossi
    Objective(s): To develop and validate an integrated clinic-molecular model for an accurate survival prognostication of newly diagnosed SMZL.
  • IELSG45 Study
    IELSG45 Randomized phase II trial on fitness- and comorbidity- tailored treatment in elderly patients with newly diagnosed primary CNS lymphoma (FIORELLA Trial)
    Participants required: 208
    Investigator responsible(s): A. Ferreri
    Objective(s): Aim of the study is to assess the safety and efficacy of the combination of rituximab and ibrutinib in EMZL patients and to explore its activity in SMZL and NMZL as exploratory subset.The primary objective of this randomized phase II trial is to compare the efficacy of a new maintenance treatment consisting of oral lenalidomide with the oral procarbazine maintenance currently in use, in elderly (≥70 years) patients with newly diagnosed PCNSL eligible to receive HD-MTX-based induction chemo-immunotherapy. Aim of the study is to assess the safety and efficacy of the combination of rituximab and ibrutinib in EMZL patients and to explore its activity in SMZL and NMZL as exploratory subset.

  • IELSG44
    IELSG44 FDG-PET evaluation for marginal zone lymphoma and its prognostic role: an international multicenter retrospective analysis (PIMENTO)
    Participants required: 350
    Investigator responsible(s): S. Luminari, C. Thieblemont, E. Zucca
    Objective(s): The IELSG44 PIMENTO study is a multicenter retrospective analysis that will assess the role of PET for the staging and for the assessment of response and outcome prediction in Marginal Zone Lymphoma (MZL).

Trials with enrolment completed – Follow-up ongoing

    IELSG43 High-dose chemotherapy and autologous stem cell transplant or consolidating conventional chemotherapy in primary CNS lymphoma – randomized phase III trial (MATRix)
    Participants required: 342 (enrolment completed)
    Investigator(s) responsible: G. Illerhaus, A. Ferreri
    Objective(s): To compare the efficacy (in terms of progression-free survival) of two consolidation policies: high-dose chemotherapy followed by autologous stem-cell transplantation and chemotherapy at conventional doses (with a regimen specifically developed for CNS lymphoma).
    IELSG42 An international phase II trial assessing tolerability and efficacy of sequential Methotrexate-Aracytin-based combination and R-ICE combination, followed by high-dose chemotherapy supported by autologous stem cell transplant, in patients with systemic B-cell lymphoma with central nervous system involvement at diagnosis or relapse (MARIETTA regimen)
    Participants required: 76 (enrolment completed)
    Investigator(s) responsible: A. Ferreri, E. Zucca, K. Cwynarski, G. Illerhaus, A. López-Guillermo, T. Siegal/O. Bairey, J. Bromberg
    Objective(s): To evaluate the efficacy and feasibility of a new sequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by R-ICE regimen, and by high-dose chemotherapy supported by ASCT.
    IELSG40 A phase II trial addressing feasibility and activity of clarithromycin + lenalidomide combination: a full oral treatment for patients with relapsed/refractory mucosa-associated lymphoid tissue (malt) lymphoma (CLEO trial)
    Participants required: 62 (patients enrolled: 44 – enrolment discontinued per protocol, after the interim analysis)
    Investigator(s) responsible: A. Ferreri, M. Raderer
    Objective(s): To assess the overall response rate (complete and partial responses) of the combination treatment of clarithromycin and lenalidomide in patients with MALT lymphoma, refractory or relapsing after radiotherapy and/or chemotherapy and/or immunotherapy.
    IELSG39 International prospective phase 2 trial addressing the efficacy of first-line Chlamydophila psittaci-eradicating therapy with protracted administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL)
    Participants required: 44 (enrolment completed)
    Investigator(s) responsible: A. Ferreri, E. Zucca, S. Govi
    Objective(s): To establish in a prospective, multicentre phase 2 trial, the efficacy of an upfront targeted therapy consisting of Cp-eradicating therapy with prolonged administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed OAMZL.
    IELSG38 A phase II study of Chlorambucil in combination with subcutaneous Rituximab followed by maintenance therapy with subcutaneous Rituximab in patients with extranodal marginal zone B-cell lymphoma of Mucosa Associated Lymphoid Tissue (MALT lymphoma)
    Participants required: 112 (enrolment completed)
    Investigator(s) responsible: A. Stathis, S. Luminari, L. Baldini, C. Thieblemont, R. Gressin, E. Zucca)
    Objective(s): to assess the therapeutic safety and activity of the combination of Chlorambucil and Rituximab given for 6 months, followed by 2 years maintenance treatment with subcutaneous Rituximab alone in MALT lymphomas.
    IELSG37 A randomized, open-label, multicentre, two-arm phase III comparative study assessing the role of mediastinal radiotherapy after Rituximab containing chemotherapy regimens to patients with newly diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL)
    Participants required: 540 (enrolment completed)
    Investigator(s) responsible: M. Martelli, A.J. Davies, M. Gospodarowicz, E. Zucca
    Objective(s): To evaluate the possibility to spare the radiotherapy in PMBCL patients, who have become “PET-negative” after a combined R-chemotherapy.
    IELSG36 BRISMA – Bendamustine and Rituximab for the treatment of Splenic Marginal Zone Lymphoma – A IELSG phase II prospective study
    Participants required: 78 (enrolment completed)
    Investigator(s) responsible: E. Iannitto, C. Thieblemont, C. Montalban)
    Objective(s): 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.
    IELSG32 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
    Participants required: 227(enrolment completed)
    Investigator(s) responsible: A. Ferreri, G. Illerhaus
    Objective(s): Primary objective of the first randomization is to establish the activity of three different chemotherapy combinations with high-dose methotrexate (HD-MTX) + high-dose cytarabine (HD-araC), HD-MTX + HDaraC + rituximab and HD-MTX + HD-araC + rituximab + thiotepa in patients with newly diagnosed PCNSL. At second randomization is to establish the efficacy of two consolidation strategies: conventional whole brain radiotherapy (WBRT) vs. high-dose chemotherapy supported by autologous stem cell transplantation (HDC + ASCT) in patients with newly diagnosed PCNSL.
    IELSG30 A phase II study of R-CHOP with intensive CNS prophylaxis and scrotal irradiation in patients with primary testicular diffuse large B-cell lymphoma
    Participants required: 54 (enrolment completed)
    Investigator(s) responsible: U. Vitolo, E. Zucca
    Objective(s): 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.

    Closed Trials

      IELSG41 A retrospective survey of extranodal marginal zone lymphoma of mucosa-associate lymphoid tissue of salivary glands.
      Investigator(s) responsible: G. Nowakowsky
      Description: A retrospective survey of extranodal marginal zone lymphoma of mucosa-associate lymphoid tissue of salivary glands.


      IELSG35 A retrospective international study of primary extranodal lymphoma of female genital tract
      Investigator(s) responsible: G. Martinelli, G. Ryan
      Description: 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.


      IELSG34 A Multicenter Phase II study to evaluate the clinical activity and the safety profile of everolimus (RAD001) in marginal zone B-cell lymphomas (MZL)
      Investigator(s) responsible: E. Zucca, A. Conconi
      IELSG33 A prospective observational study of newly diagnosed diffuse large B cell primary breast lymphomas treated with R-CHOP with or without radiotherapy
      Investigator(s) responsible: K. Ganjoo, G. Ryan, G. Martinelli
      IELSG31 A retrospective international study of primary extranodal follicular lymphoma
      Investigator(s) responsible: E. Zucca, B. Pro, Houston, M. Federico, A. Guillermo Lopez
      IELSG29 A retrospective study on primary bone marrow lymphoma
      Investigator(s) responsible: 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
      IELSG28 A retrospective international clinico-pathological study of primary extranodal marginal zone lymphoma of the lung (BALT-lymphoma)
      Investigator(s) responsible: G. Martinelli, P.L. Zinzani
      IELSG27 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
      Investigator(s) responsible: Andrés J. M. Ferreri, Milan, Italy, John Radford,
      IELSG26 Clinico-pathologic study of primary mediastinal B-cell lymphoma
      Investigator(s) responsible: P.W.M. Johnson, E. Zucca, P.L. Zinzani, , M. Martelli, A. Lopez-Guillermo
      IELSG25 Phase II Study of VELCADE in patients with extranodal marginal zone B-cell lymphoma of MALT-type pretreated with prior systemic therapy
      Investigator(s) responsible: F. Cavalli
      IELSG24 A Phase I Study of Intrathecal Rituximab in Patients with Lymphomatous Meningitis
      Investigator(s) responsible: A. Conconi, A.J.M. Ferreri, F. Cavalli
      IELSG23 A retrospective evaluation of primary head and neck lymphoma
      Investigator(s) responsible: S. Cortelazzo, G. Gaidano,
      IELSG22 Gastric irradiation for MALT lymphoma: a retrospective study
      Investigator(s) responsible: A. Wirth, J. Seymour, M. Gospodarowicz, J. Yahalom, E. Zucca,
      IELSG21 Salvage therapy with Idarubicin in immunocompetent patients with relapsed or refractory primary central nervous system lymphomas
      Investigator(s) responsible: A.J.M. Ferreri
      IELSG20 Randomized phase II trial on primary chemotherapy with high-dose methotrexate, alone or associated with high-dose cytarabine, followed by response-and age-tailored radiotherapy for immunocompetent patients with newly diagnosed primary central nervous system lymphoma
      Investigator(s) responsible: A.J.M. Ferreri
      IELSG19 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)
      Investigator(s) responsible: E. Zucca, E. Montserrat, C. Thieblemont, G. Martinelli, P. Johnson
      IELSG18 Retrospective international survey on primary effusion lymphomas
      Investigator(s) responsible: A. Conconi, A. Carbone, D. Knowles,
      IELSG17 Multi-institutional retrospective analysis of intravascular lymphomatosis
      Investigator(s) responsible: A. Ferreri, M. Ponzoni,
      IELSG16 RT-PCR detection of the t(11;18) translocation as a predictor of outcome in extranodal marginal lymphoma of MALT type
      Investigator(s) responsible: F. Bertoni, E. Zucca,
      IELSG15 Retrospective evaluation of primary breast lymphoma
      Investigator(s) responsible: G. Martinelli, G. Ryan
      IELSG14 Retrospective evaluation of primary bone lymphoma
      Investigator(s) responsible: D. Christie, M. Gospodarowicz; B. Coiffier, G. Martinelli
      IELSG13 Prevalence of hepatitis C virus (HCV) infection among non-Hodgkin lymphoma (NHL) patients Feasibility study, involving a limited number of centers
      Investigator(s) responsible: E. Zucca, A. Conconi,
      IELSG12 Chromosome 11q amplification in primary extranodal diffuse large B-cell lymphomas
      Investigator(s) responsible: F. Bertoni, E. Finbarr, B Cotter, E. Zucca
      IELSG11 Retrospective evaluation of cutaneous B-cell lymphomas
      Investigator(s) responsible: S. Cortelazzo
      IELSG10 A phase II study of CHOP plus Rituximab, with intrathecal methotrexate followed by radiotherapy, in patients with primary testicular non-Hodgkin’s lymphoma
      Investigator(s) responsible: A. Sarris
      IELSG9 Retrospective evaluation of primary mediastinal large B-cell lymphomas
      Investigator(s) responsible: P. Zinzani, M. Martelli, M. Bertini
      IELSG8 Retrospective evaluation of primary intestinal lymphomas
      Investigator(s) responsible: S. Cortelazzo
      IELSG7 Retrospective evaluation of central nervous system lymphomas
      Investigator(s) responsible: J.Y. Blay, A. Ferreri,
      IELSG6 A phase II study to determine the clinical activity and safety of Rituximab (IDEC-C2B8) in marginal zone B-cell lymphomas (MZLs)
      Investigator(s) responsible: A. Conconi, C. Thieblemont
      IELSG5 Retrospective evaluation of primary testicular lymphomas
      Investigator(s) responsible: M. Gospodarowicz, T. Mughal, U. Vitolo
      IELSG4 Prospective randomized trial of chemotherapy vs chemotherapy plus irradiation in diffuse large-cell gastric lymphoma
      Investigator(s) responsible: G. Martinelli,
      IELSG3 Randomized trial of observation vs chlorambucil after anti-helicobacter therapy in low-grade gastric lymphoma
      Investigator(s) responsible: E. Zucca, E. Roggero
      IELSG2 Retrospective analysis of patients with primary localized diffuse large B-cell lymphoma of the stomach


      IELSG1 Retrospective evaluation of low-grade MALT lymphoma primarily arising at non-gastric sites
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