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@eoc.ch.
Data collection from each study will be centralised at the IELSG Trials Coordination Centre.


ielsg46
IELSG46
Integrated Molecular and Clinical Profiling to Optimize Outcome Prediction in Splenic Marginal Zone Lymphoma
 

(D. Rossi)

Aim of the study is to develop and validate an integrated clinico-molecural model for an accurate survival prognostication in newly diagnosed SMZL.


Protocol will be provided upon request to ielsg@eoc.ch
 
ASH 2018 - Oral Presentation

IELSG43
High-dose chemotherapy and autologous stem cell transplant or consolidating conventional chemotherapy in primary CNS lymphoma - randomized phase III trial (MATRix)
268 patients

(G. Illerhaus, A. Ferreri)

Aim of the study is 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).

Protocol will be provided upon request to ielsg@eoc.ch
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ielsg40
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)
29 patients

(A. Ferreri, M. Raderer)

Aim of the study is 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
.

Protocol will be provided upon request to ielsg@eoc.ch
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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)
493 patients

(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@eoc.ch

PET accreditation and study registration

Original article: Hematol Oncol. 2017 Dec;35(4):548-553. doi: 10.1002/hon.2339.
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Enrolment Completed

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)
76 patients (enrolment completed)

(A. Ferreri, E. Zucca, K. Cwynarski, G. Illerhaus, A. López-Guillermo, T. Siegal/O. Bairey, J. Bromberg)

Aim of the study is 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.

Protocol will be provided upon request to ielsg@eoc.ch

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)
44 patients (enrolment completed)

(A. Ferreri, E. Zucca, S. Govi)

Aim of the study is 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.

Protocol will be provided upon request to ielsg@eoc.ch
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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)
112 patients (enrolment completed)

(A. Stathis, S. Luminari, L. Baldini, C. Thieblemont, R. Gressin, E. Zucca)

Aim of the study is 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.

Protocol will be provided upon request to ielsg@eoc.ch

ASH 2017 - Poster presentation
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IELSG36
BRISMA - Bendamustine and Rituximab for the treatment of Splenic Marginal Zone Lymphoma - A IELSG phase II prospective study
(Studi chair: E. Iannitto,
C. Thieblemont, C. Montalban)
78 patients (enrolment completed)

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@eoc.ch

ASH 2017 - Poster presentation

Original article:
British Journal of Haematology, Volume 185, Issue 5, December 2018, Pages 755-765.Volume 185 Issue 5
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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
(Study chair: A. Ferreri, G. Illerhaus)
227 patients
(enrolment completed)

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@eoc.ch
 
Original articles:
The Lancet Haematology, Volume 3, Issue 5, May 2016, Pages e217-e227
The Lancer Haematology, Volume 4, Issue 11, November 2017, Pages e510-e523 
The Lan
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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
(Study chair: U. Vitolo, E. Zucca)
54 patients (enrolment completed)

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@eoc.ch