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Biological Analysis of MABs in NHL in a Translational Prospective Observational Study Within Italian Clinical Practice (BIO-FIL_MAB)

2026年8月11日 更新者：Fondazione Italiana Linfomi - ETS

Multilayer Biological Analysis of Novel Monoclonal Antibodies (MABs) in B-Cell Non-Hodgkin Lymphoma (NHL): A Translational and Prospective Observational Study Within Italian Clinical Practice (BIO-FIL_MAB Trial)

This a prospective, multicenter, observational pharmacological translational study designed to investigate the biological and imaging correlates of treatment with novel monoclonal antibodies (NMABs) in patients with B-cell non-Hodgkin lymphoma (NHL), enrolled in the observationa FIL_MAB study. Patients enrolled in BIO FIL-MAB are concurrently participating in the FIL-MAB clinical cohort, ensuring that all clinical data-including treatment details, outcomes, and safety-are captured within the main observational study.

Patients will undergo systematic collection of biological specimens including tumor tissue, peripheral blood integrated with advanced imaging data. Biological analyses will encompass molecular, cellular, and immunological assessments, while imaging evaluations will include standardized functional and metabolic imaging techniques. All biological and imaging assessments will be performed as routine clinical visits, without requiring modifications to treatment or additional procedures beyond standard-of-care.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This a prospective, multicenter, observational pharmacological translational study designed to investigate the biological and imaging correlates of treatment with novel monoclonal antibodies (NMABs) in patients with B-cell non-Hodgkin lymphoma (NHL), enrolled in the observational FIL_MAB study.

All clinical observations, including baseline characteristics, treatment exposure, and follow-up, are collected through the FIL-MAB study database, with a minimum follow-up of 60 months (5 years) from enrollment and correlated with biological findings for translational analysis performed in BIO-FIL_MAB study.

The BIO-FIL_MAB study will employ a structured schedule of biological and imaging assessments to monitor treatment outcomes and gather translational data. The timeline will be aligned with routine clinical practice:

  • Prior to NMAB Treatment
  • During NMAB Therapy (3 months after start of therapy, 9 months after start of therapy, progression/relapse).

This structured schedule ensures a comprehensive evaluation of both clinical and biological treatment effects, aligning with the study's translational objectives.

As an observational translational study primarily intended for descriptive and exploratory analyses, no formal statistical hypothesis testing is planned.

Therefore, the sample size has been determined based on feasibility considerations and the expected availability of patients participating in the parent FIL-MAB clinical cohort, thereby ensuring a robust population for integrated biological, immunological, and imaging analyses in association with clinical outcomes.

Overall, it is anticipated that at least 1000 patients will be consecutively enrolled and followed longitudinally in BIO-FIL_MAB study.

研究类型

观察性的

注册 (估计的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 意大利
      • Alessandria、意大利、15121
        • SCDU Ematologia -AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria
        • 接触：
      • Aviano、意大利、33081
        • Divisione di Oncologia e dei Tumori immuno-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
        • 接触：
      • Bari、意大利、70124
      • Bergamo、意大利、24127
        • SC Ematologia - Azienda Ospedaliera Papa Giovanni XXIII - Bergamo
        • 接触：
      • Bologna、意大利、40138
        • Istituto di Ematologia "Seragnoli" - Policlinico S.Orsola-Malpighi
        • 接触：
      • Brescia、意大利、25123
      • Cuneo、意大利、12100
      • Florence、意大利、50141
      • Milan、意大利、20133
        • Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
        • 接触：
      • Milan、意大利、20162
      • Novara、意大利、28100
      • Pescara、意大利、65124
        • UOC Ematologia Dipartimento Oncologico Ematologico - P.O. Spirito Santo di Pescara - ASL Pescara
        • 接触：
      • Reggio Emilia、意大利、42123
        • Ematologia - Arcispedale Santa Maria Nuova - IRCCS -Azienda Unità Sanitaria Locale
        • 接触：
      • Roma、意大利、00161
        • Dipartimento di Medicina Traslazionale e di Precisione - Istituto Ematologia - Policlinico Umberto I - Università "La Sapienza" - Roma
        • 接触：
      • Torino、意大利、10126
        • Ematologia Universitaria - A.O.U. Città della Salute e della Scienza di Torino
        • 接触：
      • Torino、意大利、10126
      • Verona、意大利、37134
        • U.O. Ematologia - AOU Integrata di Verona
      • Vicenza、意大利、36100
    • Torino
      • Candiolo、Torino、意大利、10060
        • Ematologia - Fondazione del Piemonte per l'Oncologia - IRCCS
        • 接触：
    • Treviso
      • Castelfranco Veneto、Treviso、意大利、31033

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Being an observational translational study primarily aimed at descriptive and exploratory analyses, no formal statistical hypothesis testing is planned for BIO-FIL_MAB. The sample size is therefore determined based on feasibility and the expected availability of patients participating in the parent FIL-MAB clinical cohort. Overall, it is anticipated that at least 1000 patients will be enrolled and followed, providing a robust population for integrated biology, immunology, and imaging analyses alongside clinical outcomes.

描述

Inclusion Criteria:

  • Adults (≥18 years old) are diagnosed with B-cell Non-Hodgkin Lymphoma;
  • Patients enrolled in the FIL_MAB trial (provided by Informed Consent Form (ICF) signature) who are scheduled to receive treatment with novel monoclonal antibodies (NMABs), either as monotherapy or in combination with other therapies;
  • Written informed consent to participate in this study.

Exclusion Criteria:

  • Patients not enrolled in the FIL_MAB study.

  • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

    • Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARSCoV-2;
    • Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA;
    • HIV seropositivity;
  • Refusal or inability to provide informed consent.
  • Refusal or inability to provide biological specimens.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
T-cell engager antibodies - Work package 1 (WP 1)
WP1 includes all the FIL-MAB-approved cohorts related to novel T-cell engager therapies (e.g. bi-specifics and others).
其他：WP1 - Task 1 - Liquid analyses

Objectives

  1. To investigate the value of circulating tumor DNA (ctDNA)/ Minimal Residual Disease (MRD) status as prognostic biomarker for B-NHL patients treated with commercial bi-specifics antibodies (bsAbs).
  2. To evaluate the potential role of clonal hematopoiesis (CH) in terms of therapy-related toxicities and treatment response.
  3. To evaluate the potential prognostic role of germline single-nucleotide polymorphisms (SNPs) involved in drug metabolic pathways and cell-to-cell interactions.
其他：WP1 - Task 2 - Immunological analyses

Objectives

  1. evaluate association between levels and subtypes of T cell in PB before and after bsAbs with COs.
  2. Analyze expression of PD1, CD25, 41BB/CD137, CTLA4, CD28, and other T cell co-stimulatory molecules, and correlate with COs.
  3. Evaluate expansion of NK cells along with their markers of activation, exhaustion, maturation, chemotaxis.
  4. evaluate association between T cell exhaustion with treatment failure.
  5. evaluate association between T cell exhaustion with previous lines of treatment or other clinical factors such as relapsed time.
  6. evaluate association between T cell clusters with the development of cytopenia during treatment.
  7. investigate whether immunosenescence (composition and activation status of PBMCs) and inflammaging (soluble mediators) can predict response and clinical outcomes in elderly patients (≧70) undergoing treatment with bsAbs.
  8. Immunological characterization of T cell subset by bulk RNAseq before and after bsAbs with COs.
其他：WP1 - Task 3 - Tumor tissue analyses

Objectives

  1. Association between specific mutational (Whole Genome Sequencing, WGS) and transcriptomic (Whole Transcriptome Sequencing, WTS) patterns with disease response to bsAbs therapy.
  2. To investigate TP53 mutation and del17p as predictive factor of response to bsAbs.
  3. Identifying specific relapse patterns, with the hypothesis that alterations in tumor genes facilitating immune evasion are enriched in clones emerging at relapse (i.e., secondary resistance).
  4. To characterize intratumoral immune effector cell distribution and to assess T-cell functional fitness and exhaustion states within tumor-draining lymph nodes using Digital Spatial Profiling (DSP).
  5. To investigate the association between bsAbs surface target antigens (e.g. CD20) expression level and response to bsAbs.
其他：WP1 - Task 4 - Imaging analyses

Objectives

  1. explore how tumor metabolic activity signature predict prognosis and treatment response during bsAbs-approved treatments.
  2. explore how tumor heterogeneity activity predicts prognosis and treatment response during bsAbs -approved treatments.
  3. explore how PET findings are integrated with other biomarkers, we refine predictions of prognosis and treatment efficacy during bsAbs-approved treatments.
  4. explore novel prognostic markers of progression in CT scans and PET scans.
  5. apply advanced artificial intelligence methods (radiomics and deep learning) for automated extraction of complex imaging features from PET/CT scans, aiming to enhance prediction of prognosis and treatment response in patients undergoing bsAbs-approved treatments.
  6. develop and validate AI-driven multimodal integration frameworks that combine imaging data with clinical and molecular biomarkers, refining risk stratification and enabling early detection of progression under bsAbs therapy.
其他：WP1 - Task 5 - Microbiome and metabolomics analyses

Objectives

  1. To describe plasma and tissue microbiome composition and metabolomics during bsAbs -approved treatments.
  2. To investigate whether microbiome/metabolomics predicts outcomes during bsAbs -approved treatments.
  3. To investigate whether microbiome/metabolomics predicts treatment toxicity during bsAbs -approved treatments.
Immunoconjugates antibodies - Work package 2 (WP2)
WP2 includes all the FIL-MAB-approved cohorts related to novel immunoconjugate therapies (e.g. Antibody-Drug Conjugates (ADCs)).
其他：WP2 - Task 1 - Liquid analyses

Objectives

  1. To identify and validate biological and molecular biomarkers (i.e. ctDNA/MRD) that predict patient outcomes in patients treated with novel immunoconjugate therapies.
  2. To evaluate the potential role of clonal hematopoiesis (CH) in terms of therapy-related toxicities and treatment response.
  3. To evaluate the potential prognostic role of germline single-nucleotide polymorphisms (SNPs) involved in drug metabolic pathways and cell-to-cell interactions.
其他：WP2 - Task 2 -Immunological analyses

Objectives

  1. evaluate the association between levels and subtypes of T cells in PB before and after ADCs with COs.
  2. Analyze the expression of PD1, CD25, 41BB/CD137, CTLA4, CD28, and other T cell co-stimulatory molecules, and correlate them with COs.
  3. Evaluate the expansion of NK cells along with their markers of activation, exhaustion, maturation, chemotaxis.
  4. evaluate the association between T cell exhaustion with treatment failure.
  5. evaluate the association between T cell exhaustion with previous lines of treatment or other clinical factors such as relapsed time.
  6. evaluate the association between T cell clusters with the development of cytopenia during treatment.
  7. investigate whether immunosenescence and inflammaging can predict response and clinical outcomes in elderly patients (≧ 70) undergoing treatment with ADCs.
  8. Immunological characterization of T cell subset by bulk RNAseq before and after ADCs with clinical outcomes.
其他：WP2 - Task 3 - Tumor tissue analyses

Objectives

  1. characterize intratumoral immune effector cell distribution and assess T-cell functional fitness and exhaustion states within tumor-draining lymphnodes using DSP.
  2. investigate correlation between ADCs surface target antigens expression level and response to ADCs treatment
  3. investigate MYC translocation alone or in association with BCL2 and or BCL6 translocation or other MYC chromosomal aberrations as predictive factors of response to ADCs assessed by FISH on diagnostic biopsy and last biopsy preADCs treatment.
  4. investigate TP53 mutation and del17p as predictive factor of response to ADCs.
  5. investigate mutations and CNVs as predictive factors of response to ADCs treatment.
  6. investigate ADCs target antigens RNA expression level and correlation with response to ADCs treatment.
  7. characterize transcriptomic and sRNA landscapes to identify gene expression signatures and microRNA profiles associated with response to ADCs treatment.
其他：WP2 - Task 4 - Imaging analyses

Objectives

  1. explore how tumor metabolic activity signature predict prognosis and treatment response during ADCs-approved treatments.
  2. explore how tumor heterogeneity activity predicts prognosis and treatment response during ADCs-approved treatments.
  3. explore how PET findings are integrated with other biomarkers, we refine predictions of prognosis and treatment efficacy during ADCs-approved treatments.
  4. explore novel prognostic markers of progression in CT scans and PET scans.
  5. apply advanced artificial intelligence methods (radiomics and deep learning) for automated extraction of complex imaging features from PET/CT scans, aiming to enhance prediction of prognosis and treatment response in patients undergoing ADCs-approved treatments.
  6. develop and validate AI-driven multimodal integration frameworks that combine imaging data (PET/CT) with clinical and molecular biomarkers, refining risk stratification and enabling early detection of progression under ADCs therapy.
其他：WP2 - Task 5 - Microbiome and metabolomics analyses

Objectives

  1. To describe plasma and tissue microbiome and metabolomics composition during ADCs-treatments.
  2. To investigate whether microbiome/metabolomics predicts outcomes during ADCs-approved treatments.
  3. To investigate whether microbiome/metabolomics predicts treatment toxicity during ADCs-approved treatments.
Naked antibodies - Work package 3 (WP3)
WP3 includes all the FIL-MAB-approved cohorts related to novel naked antibodies- based therapies.
其他：WP3 - Task 1 - Liquid analyses

Objectives

  1. To identify and validate biological and molecular biomarkers (i.e. ctDNA/MRD) that predict patient outcomes in patients treated with novel naked antibodies.
  2. To evaluate the potential role of clonal hematopoiesis (CH) in terms of therapy-related toxicities and treatment response.
  3. To evaluate the potential prognostic role of germline single-nucleotide polymorphisms (SNPs) involved in drug metabolic pathways and cell-to-cell interactions.
其他：WP3 - Task 2 - Immunological analyses

Objective

1) Evaluate the expansion of immunological cells along with their markers of activation, exhaustion, maturation, and chemotaxis.

其他：WP3 - Task 3 - Tumor tissue analyses

Objectives

  1. To investigate the correlation between naked antibodies surface target antigens (e.g. CD19) expression level and response to naked antibodies.
  2. To investigate MYC translocation alone or in association with BCL2 and or BCL6 translocation, or other MYC chromosomal aberrations as predictive factors of response to naked antibodies (assessed by FISH on diagnostic biopsy and last biopsy pre- naked antibodies).
  3. To investigate TP53 mutation and del17p as predictive factor of response to naked antibodies.
  4. To investigate mutations and copy number variations (CNVs) (either studied by targeted sequencing or by WES) as predictive factors of response to treatment.
其他：WP3 - Task 4 - Imaging analyses

Objectives

  1. explore how tumor metabolic activity signature predict prognosis and treatment response during naked Abs-approved treatments.
  2. explore how tumor heterogeneity activity predicts prognosis and treatment response during naked Abs-approved treatments.
  3. explore how PET findings are integrated with other biomarkers, we refine predictions of prognosis and treatment efficacy during naked Abs-approved treatments.
  4. explore novel prognostic markers of PD in CT and PET scans.
  5. apply advanced artificial intelligence methods (radiomics and deep learning) for automated extraction of complex imaging features from PET/CT, aiming to enhance prediction of prognosis and treatment response in patients undergoing naked Abs-approved treatments.
  6. develop and validate AI-driven multimodal integration frameworks that combine imaging data with clinical and molecular biomarkers, refining risk stratification and enabling early detection of progression under naked Abs therapy.
其他：WP3 - Task 5 - Microbiome and metabolomics analyses

Objectives

  1. To describe plasma and tissue microbiome and metabolomics composition during naked antibodies -approved treatments.
  2. To investigate whether microbiome/metabolomics predicts outcomes during naked antibodies -approved treatments.
  3. To investigate whether microbiome/metabolomics predicts treatment toxicity during naked antibodies -approved treatment.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
T-cell engager antibodies - Work package (WP 1) -Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
1) Association between MRD status and Progression Free Survival (PFS).
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) -Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
2) Association between MRD status and Overall Survival (OS).
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) -Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
3) Association between between MRD status and clinical response.
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) -Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
4) Comparison between MRD negativity rates obtained by different BsAbs time to obtain MRD negativity by different BsAbs.
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) -Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
5) Correlation between baseline ctDNA levels and outcome (response, PFS, OS).
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) -Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
6) Association between MRD status and other clinical and biological prognostic markers (e.g. mutational patterns, T-cell phenotypes).
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) -Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
7) Association between baseline ctDNA and MRD with imaging biomarkers (Total Metabolic Tumor Value (TMTV), Maximum Tumor Dissemination (Dmax), Standardized Uptake Value maximum (SUVmax), Artificial Intelligence (AI) features etc).
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) -Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
8) Association of CH with PFS, OS and therapy-related toxicities.
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) -Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
9) Association of SNPs with PFS, OS and therapy-related toxicities.
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) - Task 2 -Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
1) Quantification of CD4+ and CD8+T lymphocyte clusters and soluble mediators of inflammagin, at baseline, month +3 (M3) and End Of Treatment (EOT), and correlation with clinical outcome (PFS, OS).
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) - Task 2 -Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
2) Measuring NK cells count at baseline and M3 and correlation with outcome.
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) - Task 2 -Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
3) Association between CD4+ Treg, CD4+, and CD8+ T lymphocyte counts at M3 and Complete Metabolic Response (CMR)/MRD-.
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) - Task 2 -Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
4) Association between CD4+ Treg, CD4+, and CD8+ T Lymphocyte counts at M3 and 2-Y PFS.
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) - Task 2 -Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
5) Expression of co-stimulatory molecules such as PD1, CD25, 41BB/CD137, CTLA4, and CD28 on T cells at M3 and their correlation with achieving a CMR.
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) - Task 2 -Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
6) Correlation between T cell exhaustion and treatment failure.
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) - Task 2 -Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
7) Correlation of T lymphocyte clusters and soluble mediators of inflammaging with safety (e.g. Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), infections).
from enrollment start to final analyses (15 years)
T-cell engager antibodies - Work package (WP 1) - Task 3 - Tumor tissue analyses
大体时间：from enrollment start to final analyses (15 years)
  1. Correlation of specific mutational profiles with Overall Response Rate (ORR) rates, 2-Y PFS and 2-Y OS.
  2. Correlation of specific transcriptomic signatures with ORR rates, 2-Y PFS and 2-Y OS.
  3. Correlation of intra-tumoral T-cell populations and non-T-cell populations with ORR rates, 2-Y PFS and 2-Y OS.
  4. Identifying specific relapse patterns, with the hypothesis that alterations in tumor genes facilitating immune evasion are enriched in clones emerging at relapse (i.e., secondary resistance).
  5. Correlation between target antigen surface level (i.e. CD20) with ORR rates, 2-Y PFS and 2-Y OS.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
1) Association between MRD status and PFS.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
2) Association between MRD status and OS.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
3) Association between MRD status and clinical response.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
4) Comparison between MRD negativity rates obtained by different BsAbs time to obtain MRD negativity by different BsAbs.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
5) Correlation between baseline ctDNA levels and outcome (response, PFS, OS).
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
6) Association between MRD status and other clinical and biological prognostic markers (e.g. mutational patterns, T-cell phenotypes).
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
7) Association between baseline ctDNA and MRD with imaging biomarkers (TMTV, Dmax, SUVmax, AI features etc).
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
8) Association of CH with PFS, OS and therapy-related toxicities.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
9) Association of SNPs with PFS, OS and therapy-related toxicities.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 2 - Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
1) Quantification of CD4+ and CD8+T lymphocyte clusters and soluble mediators of inflammagin, at baseline, month +3 (M3) and EOT, and correlation with clinical outcome (PFS, OS).
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 2 - Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
2) Measuring NK cells count at baseline and M3 and correlation with outcome.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 2 - Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
3) Association between CD4+ Treg, CD4+, and CD8+ T lymphocyte counts at M3 and CMR/MRD-.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 2 - Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
4) Association between CD4+ Treg, CD4+, and CD8+ T Lymphocyte counts at M3 and 2-Y PFS.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 2 - Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
5) Expression of co-stimulatory molecules such as PD1, CD25, 41BB/CD137, CTLA4, and CD28 on T cells at M3 and their correlation with achieving a CMR.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 2 - Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
6) Correlation between T cell exhaustion and treatment failure.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 2 - Immunological analyses
大体时间：from enrollment start to final analyses (15 years)
7) Correlation of T lymphocyte clusters and soluble mediators of inflammaging with safety (e.g. infections).
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 3 - Tumor tissue analyses
大体时间：from enrollment start to final analyses (15 years)
1) Association between target antigen surface level and CRR with ADCs treatment, assessed in immunohistochemistry (IHC) on diagnosis or last relapse biopsy before ADCs treatment.
from enrollment start to final analyses (15 years)
Immunoconjugates antibodies - Work package 2 (WP2) Task 3 - Tumor tissue analyses
大体时间：from enrollment start to final analyses (15 years)
2) Association between target antigen surface level and OS, PFS and ORR with ADCs treatment, assessed in immunohistochemistry (IHC) on diagnosis or last relapse biopsy before ADCs treatment and correlation with biological and imaging predictors. Correlation of CH with PFS, OS and therapy-related toxicities and correlation of SNPs with PFS, OS and therapy-related toxicities.
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
1) Association between MRD status and PFS.
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
2) Association between MRD status and OS.
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
3) Association between MRD status and clinical response.
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
4) Comparison between MRD negativity rates obtained by different naked antibodies time to obtain MRD negativity by different naked antibodies.
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
5) Correlation between baseline ctDNA levels and outcome (response, PFS, OS).
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
6) Association between MRD status and other clinical and biological prognostic markers (e.g. mutational patterns, T-cell phenotypes).
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
7) Association between baseline ctDNA and MRD with imaging biomarkers (TMTV, Dmax, SUVmax, AI features etc).
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
8) Association of CH with PFS, OS and therapy-related toxicities.
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 1 - Liquid analyses
大体时间：from enrollment start to final analyses (15 years)
9) Association of SNPs with PFS, OS and therapy-related toxicities.
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 3 - Tumor tissue analyses
大体时间：from enrollment start to final analyses (15 years)
1) Association between target antigen surface level and CRR with naked antibodies-based treatment, assessed in immunohistochemistry (IHC) on diagnosis or last relapse biopsy before naked antibodies-based therapies.
from enrollment start to final analyses (15 years)
Naked antibodies - Work package 3 (WP3) Task 3 - Tumor tissue analyses
大体时间：from enrollment start to final analyses (15 years)
2) Association between target antigen surface level and OS, PFS and ORR with naked antibodies based-treatment, assessed in immunohistochemistry (IHC) on diagnosis or last relapse biopsy before naked antibodies based-treatment and correlation with biological and imaging predictors. Correlation of CH with PFS, OS and therapy-related toxicities and correlation of SNPs with PFS, OS and therapy-related toxicities.
from enrollment start to final analyses (15 years)
All Work packages
大体时间：from enrollment start to final analyses (15 years)
1) Prognostic quantitative PET indices: Metabolic Tumor Volume (MTV), Total Glycolytic Volumes (TLG), SUVmax and SUVpeak, other index of tumor dissemination (maximum distance between the lesion, product of distance and MTV, etc.…) and radiomics index.
from enrollment start to final analyses (15 years)
All Work packages
大体时间：from enrollment start to final analyses (15 years)
2) Association between plasma and lymph nodes microbiome and outcomes (ORR, Complete Response Rate (CRR), PFS, OS) in NMAB-approved treatments.
from enrollment start to final analyses (15 years)
All Work packages
大体时间：from enrollment start to final analyses (15 years)
3) Evaluation of correlations between immune cell subsets (T-cell subsets, NK cells), immunological clusters, soluble mediators, and clinical efficacy.
from enrollment start to final analyses (15 years)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fondazione Italiana Linfomi - ETS

调查人员

  • 学习椅：Riccardo Moia, MD、Divisione di Ematologia, Dipartimento di Medicina Traslazionale Università del Piemonte Orientale, AOU Maggiore della Carità, Novara (Italy)
  • 学习椅：Simone Ferrero, Prof.、Ematologia Universitaria, A.O.U. Città della Salute e della Scienza di Torino, Torino (Italy)
  • 学习椅：Rita Tavarozzi, MD、SCDU Ematologia, Azienda Ospedaliera SS Antonio e Biagio e C. Arrigo, Alessandria, Italy

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2041年10月1日

研究完成 (估计的)

2041年10月1日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月11日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BIO-FIL_MAB

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Qualified researchers may contact the FIL board at segreteriadirezione@filinf.it to share invidual-level patients' clinical data analysed for this manuscript (for the avoidance of doubt, no identifiable data, such as name, address, hospital name, date of birth, or any other identifying data, will be shared and should not be requested).

IPD 共享时间框架

In compliance with the domestic ethics guideline and applicable legislation, invidual deindentified patients' data underlying the results reported in the publication article (including study protocol, statistical analysis plan and data coding) can be shared until 5 years after the publication of the article.

IPD 共享访问标准

For each data sharing request, it is essential that a proforma (available on request) is completed that describes the general purpose, specific aims, data items requested, analysis plan and acknowledgment of the trial management team. Requests will be reviewed based on scientific merit and ethical principles. Requestors who are granted access to the data will be required to complete a data sharing agreement that will be signed by the requester and FIL.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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