Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339255
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-01-04
Brief Title:
Italian Observational Study on CAR-T Therapy for Lymphoma
Sponsor:
Paolo Corradini
Organization:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Study Overview
Official Title:
A Multicenter Prospective Observational Study on Chimeric Antigen Receptor CAR T-cell Therapy for Lymphoma Monitoring Feasibility Efficacy Toxicity and Biomarkers in a Real Life Setting
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CART-SIE
Brief Summary:
The goal of this observational study on chimeric antigen receptor T-cell therapy is to monitor the feasibility efficacy toxicity and biomarkers in a real life setting
Partecipants will be asked to agree to their clinical data collection and to partecipate to the optional biological study that aims to evaluate biomarkers of toxicity and response clinical characteristics cytokine profile cellcomposition and type of the CAR-T cell product lymphoma genomics The study will evaluate even the disease response according to lugano criteria by PET and CT in routine clinical activity
Partecipants will be asked to agree to their clinical data collection and to partecipate to the optional biological study that aims to evaluate biomarkers of toxicity and response clinical characteristics cytokine profile cellcomposition and type of the CAR-T cell product lymphoma genomics The study will evaluate even the disease response according to lugano criteria by PET and CT in routine clinical activity
Detailed Description:
This observational prosopective multicenter study aims to
1 evaluate the feasibility of CAR T-cell treatment in the real-life setting with particular regard to eligible patients versus those subjected to leukapheresis versus those finally treated
2 evaluate the survival outcome of PMBCL DLBCL MCL and FL patients treated with CAR T-cells versus those potentially eligible but excluded from cellular therapy for other causes either related to the patient or to the manufacturing
3 monitor the incidence of early and late AEs up to three year after CAR-T
4 evaluate disease response and immune recovery biomarkers at different time-points up after CAR-T when clinically indicated or using blood sampling leftover
5 evaluate biomarkers of toxicity and response clinical characteristics cytokine profile cell composition and type of the CAR T-cell product lymphoma genomics
6 evaluate disease response according to Lugano criteria by PET and CT in routine clinical activity
Primary Objective
Feasibility and efficacy of the treatment in the real life practice
Secondary Objectives
Evaluation of Outcome Response rate ORR Overall survival OS Progression free survival PFS duration of response DoR non-relapse mortality NRM according to Lugano criteria
Evaluation of safety CRS neurotoxicity infections cytopenias B cell aplasia second malignancies with particular attention to the safety in the new indications
Evaluation of bridging therapy outcome and safety
Evaluation of salvage therapy after CAR-T failure outcome and safety
Comparison of the different CAR T-cell products time from patient screening to infusion disease response and safety
Comparison of the different histotypes PMBCL DLBCL MCL FL according to CAR-T cell products
Biological Studies
Characterization of biomarkers of early response circulating tumor cell free DNA versus PET and CT scans
Characterization of toxicity biomarkers
Analysis of the immune reconstitution and CAR-T expression Radiomics Evaluation
Influence of PET quantitative parameters tMTV Distance max Distance max bulky metabolic changes between baseline and 30 and 90 after CAR T-cell infusion ΔSUV max on outcome
Influence of PET quantitative parameters tMTV Distance max Distance max bulky metabolic changes between baseline and 30 and 90 after CAR T-cell infusion ΔSUV max on outcome
Primary endpoint
to evaluate the percentage of patients infused versus those eligible and leukoapheresed to evaluate the overall response and survival at one year of the patients treated with CAR T cells
Secondary endpoints
Overall response rate ORR at 3-6-12-18 months Overall survival OS for all patients included in the study OS Progression free survival PFS Event free survival EFS and duration of response DoR non-relapse mortality NRM after CAR T-cell therapy at onetwo years and 5 years Incidence and grading of CRS and neurotoxicity Number of patients receiving a bridging therapy before lymphodepletion Intensive Care Unit admission rate for all treated patients Lymphoma genomics and circulating cell free DNA as early response biomarker Characterization of toxicity biomarkers Analysis of immune reconstitution and CAR-T expression Early Adverse event gradingonsetseveritytreatment Long term Safety AE gradingonsetseveritytreatment Incidence of second malignancies Evaluation of quantitative parameters of PET by central review when applicable in selected sites This is an observational multicenter prospective study enrolling all consecutive patients referred to the Italian hematologic centers already qualified for CAR T-cell treatment with relapsedrefractory DLBCL PMBCL MCL and FL The screening will be done according to the axi-cel tisagen-cel brexucabtagene autoleucel and lisocabtagene maraleucel label criteria the eligibility of a given patient to CAR-T will be definedaccording to AIFA criteria
All patients eligible to CAR-T will be consecutively enrolled Biological samples will be stored at each institution or centralized at the Fondazione IRCCS Istituto Nazionale dei Tumori Milano Fondazione Italiana Linfomi FIL will be in charge of the GCP management of the study Web-based CRF are prepared by FIL
1 evaluate the feasibility of CAR T-cell treatment in the real-life setting with particular regard to eligible patients versus those subjected to leukapheresis versus those finally treated
2 evaluate the survival outcome of PMBCL DLBCL MCL and FL patients treated with CAR T-cells versus those potentially eligible but excluded from cellular therapy for other causes either related to the patient or to the manufacturing
3 monitor the incidence of early and late AEs up to three year after CAR-T
4 evaluate disease response and immune recovery biomarkers at different time-points up after CAR-T when clinically indicated or using blood sampling leftover
5 evaluate biomarkers of toxicity and response clinical characteristics cytokine profile cell composition and type of the CAR T-cell product lymphoma genomics
6 evaluate disease response according to Lugano criteria by PET and CT in routine clinical activity
Primary Objective
Feasibility and efficacy of the treatment in the real life practice
Secondary Objectives
Evaluation of Outcome Response rate ORR Overall survival OS Progression free survival PFS duration of response DoR non-relapse mortality NRM according to Lugano criteria
Evaluation of safety CRS neurotoxicity infections cytopenias B cell aplasia second malignancies with particular attention to the safety in the new indications
Evaluation of bridging therapy outcome and safety
Evaluation of salvage therapy after CAR-T failure outcome and safety
Comparison of the different CAR T-cell products time from patient screening to infusion disease response and safety
Comparison of the different histotypes PMBCL DLBCL MCL FL according to CAR-T cell products
Biological Studies
Characterization of biomarkers of early response circulating tumor cell free DNA versus PET and CT scans
Characterization of toxicity biomarkers
Analysis of the immune reconstitution and CAR-T expression Radiomics Evaluation
Influence of PET quantitative parameters tMTV Distance max Distance max bulky metabolic changes between baseline and 30 and 90 after CAR T-cell infusion ΔSUV max on outcome
Influence of PET quantitative parameters tMTV Distance max Distance max bulky metabolic changes between baseline and 30 and 90 after CAR T-cell infusion ΔSUV max on outcome
Primary endpoint
to evaluate the percentage of patients infused versus those eligible and leukoapheresed to evaluate the overall response and survival at one year of the patients treated with CAR T cells
Secondary endpoints
Overall response rate ORR at 3-6-12-18 months Overall survival OS for all patients included in the study OS Progression free survival PFS Event free survival EFS and duration of response DoR non-relapse mortality NRM after CAR T-cell therapy at onetwo years and 5 years Incidence and grading of CRS and neurotoxicity Number of patients receiving a bridging therapy before lymphodepletion Intensive Care Unit admission rate for all treated patients Lymphoma genomics and circulating cell free DNA as early response biomarker Characterization of toxicity biomarkers Analysis of immune reconstitution and CAR-T expression Early Adverse event gradingonsetseveritytreatment Long term Safety AE gradingonsetseveritytreatment Incidence of second malignancies Evaluation of quantitative parameters of PET by central review when applicable in selected sites This is an observational multicenter prospective study enrolling all consecutive patients referred to the Italian hematologic centers already qualified for CAR T-cell treatment with relapsedrefractory DLBCL PMBCL MCL and FL The screening will be done according to the axi-cel tisagen-cel brexucabtagene autoleucel and lisocabtagene maraleucel label criteria the eligibility of a given patient to CAR-T will be definedaccording to AIFA criteria
All patients eligible to CAR-T will be consecutively enrolled Biological samples will be stored at each institution or centralized at the Fondazione IRCCS Istituto Nazionale dei Tumori Milano Fondazione Italiana Linfomi FIL will be in charge of the GCP management of the study Web-based CRF are prepared by FIL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None