Indolent Non Follicular Lymphomas Prognostic Project

Study Overview
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Brief Summary
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Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas.

Detailed Description
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The present study is designed as a prospective collection of information potentially useful to predict the prognosis of newly diagnosed patients with non-follicular low grade B-cell lymphoma. The study is aimed to verify whether a prognostic collection of data would allow the development of a more accurate prognostic assessment for non-follicular low grade B-cell lymphomas.

Official Title
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Indolent Non Follicular Lymphomas Prognostic Project - Prospective Collection of Data of Possible Prognostic Relevance in Patients With Indolent Non-follicular B-CELL Lymphomas

Conditions
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Indolent B-Cell Lymphomas

Intervention / Treatment
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* Other: Any treatment, watch and wait policy included


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed diagnosis of non-follicular low grade B-cell lymphoma Splenic MZL (bone marrow histology and/or spleen tissue) Extranodal MZL of MALT (tissue biopsy) Nodal MZL (lymph node biopsy) Lymphocytic lymphoma (lymph node biopsy) Lymphoplasmacytic lymphoma (bone marrow histology or lymph node biopsy) CD5-negative low grade B-cell lymphoma (bone marrow histology) Age over 18 Written informed consent Exclusion Criteria: 1. None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training and validation cohort<br>One cohort: from this cohort 2/3 of patients will be randomly separated after registration in training sample, to develop a prognostic model, and 1/3 in test sample, to validate the prognostic score obtained from the prognostic model. The training cohort aims to develop a prognostic model and a resulting score, on the basis of clinical, biochemical and blood count parameters, in patients with non-follicular indolent lymphomas. Intervention: any treatment, watch and wait policy included The validation cohort is aims to assess the prognostic score on a collected set of data in parallel but independently of the sample training. Intervention: any treatment, watch and wait policy included | Other: Any treatment, watch and wait policy included<br>* Patients registered in the study despite their planned treatment, watch and wait policy included. The planned treatment mentioned in the protocol is just the ideal approach proposed by investigators.The treatment can change depending on the evolution of the disease, without this affects the study's purposes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival for the treated cohort | Progression free survival (PFS) will be measured from the date of randomization to the date of documented first occurrence of disease progression or relapse or to the date of death from any cause. Patients who are lost to follow up will be censored at their last assessment date. | September 2024 (13 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival for the untreated cohort | Progression free survival (PFS) will be measured from the date of randomization to the date of documented first occurrence of disease progression or relapse or to the date of death from any cause. Patients who are lost to follow up will be censored at their last assessment date. | September 2024 (13 years) | 
| Overall survival | Overall survival (OS) is defined as the time from the study entry until the date of death irrespective of cause. Patients who have not died at the time of end of the whole study , and patients who are lost to follow up , will be censored at the date of the last contact. | September 2024 (13 years) | 
| Event-free survival | Event Free Survival (EFS) is measured from the time from study entry to any treatment failure including disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, patient preference, initiation of new treatment without documented progression) or death from any cause. | September 2024 (13 years) | 
| Remission rate with initial therapy | Remission rate (RR) is defined as the number of complete and partial remission (CR and PR) after the completion of the first line of treatment. | September 2017 (Six years) | 
| Epidemiology | Will be collected the risk factors potentially associated to the outcome of indolent non follicular lymphomas (clinical status, biochemistry, hemochrome, HCV, HBV and autoimmnity markers). Will be collected the risk factors potentially associated to the outcome of indolent non follicular lymphoma (clinical status, biochemistry, hemochrome, HCV, HBV and autoimmunity markers). Those risk factors will be utilized to obtain a prognostic model (prognostic index) from the Cox proportional hazard regression and, finally, a prognostic score grouping the prognostic index in at least three group of risk (low, intermediate, high risk). | September 2016 (Five years) | 
| Time dependent analysis for patients in Watch & Wait policy. | In WW group the start of treatment will be treated as a time-varying covariate in Cox proportional hazard regression. | September 2024 (13 years) | 
| Remission rates with second and subsequent lines of therapy | Remission rate (RR) is defined as the number of CR and PR after the second and subsequent lines of therapy, due to progression disease. | September 2024 (13 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indolent B-Cell Lymphomas, prospective collection