Clinical trial · Observational
Indolent Non Follicular Lymphomas Prognostic Project
Indolent Non Follicular Lymphomas Prognostic Project - Prospective Collection of Data of Possible Prognostic Relevance in Patients With Indolent Non-follicular B-CELL Lymphomas
NCT02904577CI-TRIAL-00093342completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective collection of data of possible prognostic relevance in patients with indolent non - follicular B-CELL Lymphomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indolent B-Cell Lymphomas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Any treatment, watch and wait policy included | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Training and validation cohort
- description
- 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
- interventionNames
- Other: Any treatment, watch and wait policy included
Primary outcomes (1)
- measure
- Progression-free survival for the treated cohort
- timeFrame
- September 2024 (13 years)
- description
- 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 outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLuminari S, Merli M, Rattotti S, Tarantino V, Marcheselli L, Cavallo F, Varettoni M, Bianchi B, Merli F, Tedeschi A, Cabras G, Re F, Visco C, Torresan Delamain M, Cencini E, Spina M, Ferrero S, Ferrari A, Deodato M, Mannina D, Annibali O, Rago A, Orsucci L, Defrancesco I, Frigeni M, Cesaretti M, Arcaini L. Early progression as a predictor of survival in marginal zone lymphomas: an analysis from the FIL-NF10 study. Blood. 2019 Sep 5;134(10):798-801. doi: 10.1182/blood.2019001088. Epub 2019 Jul 10. PMID 31292118