Indolent B-Cell Lymphomas
Conditions
Keywords
Indolent B-Cell Lymphomas, prospective collection
Brief summary
Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas.
Detailed description
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.
Interventions
OTHERAny treatment, watch and wait policy included
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.
Sponsors
Fondazione Italiana Linfomi - ETS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. Age over 18 3. Written informed consent
Exclusion criteria
1\. None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival for the treated cohort | September 2024 (13 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | September 2024 (13 years) | 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. |
| Event-free survival | September 2024 (13 years) | 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. |
| Remission rate with initial therapy | September 2017 (Six years) | 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. |
| Progression-free survival for the untreated cohort | September 2024 (13 years) | 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. |
| Time dependent analysis for patients in Watch & Wait policy. | September 2024 (13 years) | In WW group the start of treatment will be treated as a time-varying covariate in Cox proportional hazard regression. |
| Remission rates with second and subsequent lines of therapy | September 2024 (13 years) | Remission rate (RR) is defined as the number of CR and PR after the second and subsequent lines of therapy, due to progression disease. |
| Epidemiology | September 2016 (Five years) | 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). |
Countries
Austria, Brazil, France, Italy, Portugal, Ukraine
Outcome results
None listed