Clinical Trial: Indolent Non Follicular Lymphomas Prognostic Project

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary:

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.


Sponsor: Fondazione Italiana Linfomi ONLUS

Current Primary Outcome: Progression-free survival for the treated cohort [ Time Frame: September 2022 (11 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression-free survival for the untreated cohort [ Time Frame: September 2022 (11 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.
  • Overall survival [ Time Frame: September 2022 (11 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 [ Time Frame: September 2022 (11 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 [ Time Frame: 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.
  • Epidemiology [ Time Frame: 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).
  • Time dependent analysis for patients in Watch & Wait policy. [ Time Frame: September 2022 (11 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 [ Time Frame: September 2022 (11 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.


Original Secondary Outcome: Same as current

Information By: Fondazione Italiana Linfomi ONLUS

Dates:
Date Received: September 6, 2016
Date Started: September 2011
Date Completion: September 2022
Last Updated: March 22, 2017
Last Verified: September 2016