Transformed Splenic Marginal Zone LymphomaNCT06712459
Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma
An observational study of Transformed Splenic Marginal Zone Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 7 sites in 7 countries.
Trial summary
Histological transformation in Splenic Marginal Zone Lymphoma (t-SMZL) represents an unmet clinical and biological need, invariably associated with poor prognosis and reduced overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transformed Splenic Marginal Zone Lymphoma
- How many people
- 100 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 13 Oct 2025to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with transformed SMZL
Who may be able to join
- Adults aged 18 years or older, regardless of the gender;
- Diagnosis of HT of SMZL (both at baseline, co-occurring with diagnosis of SMZL, or during the natural history of the disease);
- Availability of diagnostic tumor material (either frozen or FFPE) from spleen, lymph node, extra nodal site, peripheral blood or bone marrow collected at the time of histological transformation. Tumor material (either frozen or FFPE), from spleen, peripheral blood or bone marrow, collected at the time of SMZL diagnosis will be also collected, if available;
- Availability of the baseline and follow-up annotations.
Who cannot join
- None
Trial locations and contacts
7 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 7 countries
United States1 site, 1 recruiting
- Not yet recruiting
Columbia University
New York, New York, 10032
Govind Bhagat, MD, gb96@cumc.columbia.edu
Govind Bhagat, MD
Belgium1 site, 1 recruiting
- Not yet recruiting
Universitz Hospitals Leuven
Leuven, 3000
Thomas Tousseyn, MD, thomas.tousseyn@kuleuven.be
Thomas Tousseyn, MD
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Louis
Paris, 75475
Catherine Thieblemont, MD, catherine.thieblemont@aphp.fr
Catherine Thieblemont, MD
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Luca Arcaini, MD, luca.arcaini@unipv.it
Luca Arcaini, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
ARMANDO LÓPEZ GUILLERMO, MD
alopezg@clinic.cat
Switzerland1 site, 1 recruiting
- Not yet recruiting
Oncology Institute of Southern Switzerland
Bellinzona, 6500
Maria Cristina Pirosa, MD, maria.pirosa@eoc.ch
Maria Cristina Pirosa, MD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
University Hospitals Dorset
Bournemouth, BH7 7DW
Renata Walewska, MD, Renata.Walewska@uhd.nhs.uk
Renata Walewska, MD
About this study
Histological transformation in Splenic Marginal Zone Lymphoma (t-SMZL) represents an unmet clinical and biological need, invariably associated with poor prognosis and reduced overall survival. At the present time, there are no recommended treatments intended specifically to t-SMZL and little is known about t-SMZL genetic complexity. The aim of this study is to provide information that will help clinicians to better understand the complexity of the disease. The information gained from this study will also lead to more specific and effective treatment for patients with t-SMZL.
Read the detailed description
Already existing and coded tumor biological material and health-related patient data will be retrospectively collected from institutional biobanks and patients' charts or electronic medical records upon receipt of ethical approval. Each patient enrolled in the study will be assigned a unique identification numerical code upon registration in the study. The unique identification code will be used to record health-related data and to label biological samples. Health-related data will be collected by electronic case report form (e-CRF) system. Data quality will be insured by query generation.
Annotated baseline features will include: date of diagnosis, date and tissue type of histological sample collected at diagnosis (spleen and/or bone marrow), age, gender, Eastern Cooperative Oncology Group - Performing Status (ECOG-PS), Ann Arbor stage, Lactate Dehydrogenase (LDH), number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, bulky disease (>7 cm), number of nodal sites, B symptoms, hemoglobin, platelets, lymphocytes, beta-2-microglobulin, albumin, Hepatitis C Virus (HCV) infection, serum paraprotein and type.
Annotated follow-up features will include: the date of progression to a disease requiring treatment, type of first line treatment, date of start of the first line treatment, date of progression after first line treatment, date of the second line treatment, type of second line treatment.
Annotated transformation features will include: date of transformation, date and type of histological sample collected at transformation (spleen and/or bone marrow and/or lymph node and/or other site), histological transformation type and relative molecular data (if available), ECOG-PS, Ann Arbor stage, LDH, number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, bulky disease (>7 cm), number of nodal sites, B symptoms, hemoglobin, platelets, lymphocytes, beta-2-microglobulin, albumin, serum paraprotein, and type.
Survival features will include the date of death, cause of death, date of last follow-up.
Mutation analysis, immunoglobulin gene rearrangement analysis, copy number aberration analysis, structural variant analysis, and DNA methylation profile will be performed by Next Generation Sequencing (NGS) of genomic DNA extracted from the biological sample available for the analysis. Gene expression will be assessed by NGS of RNA extracted from from the biological sample available for the analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of mutations, copy number abnormalities and structural variants at SMZL diagnosis and at HT
Measured: 30 months: from the end of samples collection to the end of study analysis
Quantification and qualification of lesions acquired at the time of HT.
Measured: 30 months: from the end of samples collection to the end of study analysis
Prevalence of clonal relationship between SMZL and HT
Measured: 30 months: from the end of samples collection to the end of study analysis
Secondary outcomes (4)
Prevalence of HT molecular subtypes defined by genetic lesions
Measured: 30 months: from the end of samples collection to the end of study analysis
Prevalence of Histological Transformation (HT) molecular subtypes defined by gene expression
Measured: 30 months: from the end of samples collection to the end of study analysis
Prevalence of HT molecular subtypes defined by genetic methylation profile
Measured: 30 months: from the end of samples collection to the end of study analysis
Prevalence of molecular features in relation with clinical, laboratory and radiological/Positron Emission Tomography (PET) features at SMZL diagnosis and at HT
Measured: 30 months: from the end of samples collection to the end of study analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start13 Oct 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transformed Splenic Marginal Zone LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Arcaini, MD, Study chair, Fondazione IRCCS Policlinico San MatteoDavide Rossi, MD, Study chair, Oncology Institute of Southern Switzerland (IOSI) and Institute of Oncology Research (IOR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712459
- Sponsor's protocol ID
- IELSG54
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT06712459
- Acronym / sponsor ID
- IELSG54
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Histological transformation in Splenic Marginal Zone Lymphoma (t-SMZL) represents an unmet clinical and biological need, invariably associated with poor prognosis and reduced overall survival. At the present time, there are no recommended treatments intended specifically to t-SMZL and little is known about t-SMZL genetic complexity. The aim of this study is to provide information that will help clinicians to better understand the complexity of the disease. The information gained from this study will also lead to more specific and effective treatment for patients with t-SMZL.
Detailed description
Already existing and coded tumor biological material and health-related patient data will be retrospectively collected from institutional biobanks and patients' charts or electronic medical records upon receipt of ethical approval. Each patient enrolled in the study will be assigned a unique identification numerical code upon registration in the study. The unique identification code will be used to record health-related data and to label biological samples. Health-related data will be collected by electronic case report form (e-CRF) system. Data quality will be insured by query generation.
Annotated baseline features will include: date of diagnosis, date and tissue type of histological sample collected at diagnosis (spleen and/or bone marrow), age, gender, Eastern Cooperative Oncology Group - Performing Status (ECOG-PS), Ann Arbor stage, Lactate Dehydrogenase (LDH), number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, bulky disease (>7 cm), number of nodal sites, B symptoms, hemoglobin, platelets, lymphocytes, beta-2-microglobulin, albumin, Hepatitis C Virus (HCV) infection, serum paraprotein and type.
Annotated follow-up features will include: the date of progression to a disease requiring treatment, type of first line treatment, date of start of the first line treatment, date of progression after first line treatment, date of the second line treatment, type of second line treatment.
Annotated transformation features will include: date of transformation, date and type of histological sample collected at transformation (spleen and/or bone marrow and/or lymph node and/or other site), histological transformation type and relative molecular data (if available), ECOG-PS, Ann Arbor stage, LDH, number and location of extranodal sites, bone marrow involvement and percentage, peripheral blood involvement, bulky disease (>7 cm), number of nodal sites, B symptoms, hemoglobin, platelets, lymphocytes, beta-2-microglobulin, albumin, serum paraprotein, and type.
Survival features will include the date of death, cause of death, date of last follow-up.
Mutation analysis, immunoglobulin gene rearrangement analysis, copy number aberration analysis, structural variant analysis, and DNA methylation profile will be performed by Next Generation Sequencing (NGS) of genomic DNA extracted from the biological sample available for the analysis. Gene expression will be assessed by NGS of RNA extracted from from the biological sample available for the analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with transformed SMZL
Key inclusion criteria (4 listed)
- Adults aged 18 years or older, regardless of the gender;
- Diagnosis of HT of SMZL (both at baseline, co-occurring with diagnosis of SMZL, or during the natural history of the disease);
- Availability of diagnostic tumor material (either frozen or FFPE) from spleen, lymph node, extra nodal site, peripheral blood or bone marrow collected at the time of histological transformation. Tumor material (either frozen or FFPE), from spleen, peripheral blood or bone marrow, collected at the time of SMZL diagnosis will be also collected, if available;
- Availability of the baseline and follow-up annotations.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of mutations, copy number abnormalities and structural variants at SMZL diagnosis and at HT
Time frame: 30 months: from the end of samples collection to the end of study analysis
Quantification and qualification of lesions acquired at the time of HT.
Time frame: 30 months: from the end of samples collection to the end of study analysis
Prevalence of clonal relationship between SMZL and HT
Time frame: 30 months: from the end of samples collection to the end of study analysis
4 secondary outcomes
Prevalence of HT molecular subtypes defined by genetic lesions
Time frame: 30 months: from the end of samples collection to the end of study analysis
Prevalence of Histological Transformation (HT) molecular subtypes defined by gene expression
Time frame: 30 months: from the end of samples collection to the end of study analysis
Prevalence of HT molecular subtypes defined by genetic methylation profile
Time frame: 30 months: from the end of samples collection to the end of study analysis
Prevalence of molecular features in relation with clinical, laboratory and radiological/Positron Emission Tomography (PET) features at SMZL diagnosis and at HT
Time frame: 30 months: from the end of samples collection to the end of study analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Arcaini, MD study chair
Fondazione IRCCS Policlinico San Matteo
Davide Rossi, MD study chair
Oncology Institute of Southern Switzerland (IOSI) and Institute of Oncology Research (IOR)
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transformed Splenic Marginal Zone Lymphoma, run by International Extranodal Lymphoma Study Group (IELSG) at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Belgium, France, Italy, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IELSG Study Coordination Office (+41 58 666 7321, ielsg@ior.usi.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of mutations, copy number abnormalities and structural variants at SMZL diagnosis and at HT (time frame: 30 months: from the end of samples collection to the end of study analysis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.