Indolent Non Follicular Lymphomas Prognostic Project

Active, not recruiting

• Conditions: Indolent B-Cell Lymphomas

• Registration Number: NCT02904577
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Status Verified: 2024-12
• Primary Completion: 2024-12
• Study Completion: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 370

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 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.
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).
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.

Trial Locations

Locations (46)

Vienna Univ Med Int I; 🇦🇹 Vienna, Austria

Center of Hematology and Hemotherapy, UNICAMP, University of Campinas; 🇧🇷 Campinas, Brazil

Universidade Federal Do Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil

São Paulo-Santa Casa Medical School; 🇧🇷 São Paulo, Brazil

Hospital Saint-Louis; 🇫🇷 Paris, France

UO Oncoematologia Ospedale Umberto I; 🇮🇹 Pagani, Salerno, Italy

Oncologia Medica A - Centro di Riferimento Oncologico; 🇮🇹 Aviano (PN), Italy

UO Ematologia con Trapianto Policlinico Consorziale; 🇮🇹 Bari, Italy

USC Ematologia Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Ematologia e CTMO Ospedale Businco; 🇮🇹 Cagliari, Italy

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