NCT06712459 · International Extranodal Lymphoma Study Group (IELSG)
Integrated Molecular and Clinical Profiling of Transformed Splenic Marginal Zone Lymphoma
What this study is about
Histological transformation in Splenic Marginal Zone Lymphoma (t-SMZL) represents an unmet clinical and biological need, invariably associated with poor prognosis and reduced how long patients live. At the present time, there are no recommended treatments intended specifically to t-SMZL and little is known about t-SMZL genetic complexity.
View original scientific description
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2026 · Source of record for eligibility and locations