Development of Prognostic Models for Response and Toxicity to CAR-T Cell Therapy in Patients with Relapsed/refractory Non Hodgkin's Lymphoma. (CLIO)

Observational, single-center, tissue-based cohort study involving both retrospective and prospective enrollment of patients undergoing CAR-T cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Hodgkin Lymphoma

Detailed Description

This is a pharmacological observational study, with collection of biological material, single-centre, no-profit, involving both retrospective and prospective enrolment of patients undergoing CAR-T cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study.

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Pier Luigi Zinzani, MD; Phone Number: +39 0512143680; Email: pierluigi.zinzani@unibo.it
• Study Contact Backup: Name: Beatrice Casadei, MD; Phone Number: +39 0512143680; Email: beatrice.casadei10@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna
    • Contact: Beatrice Casadei, MD; Phone Number: +39 0512143680; Email: beatrice.casadei10@unibo.it
    • Contact: Pier Luigi Zinzani; Phone Number: +390512144042; Email: pierluigi.zinzani@unibo.it
    • Contact: Zinzani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

125 patients who will participate in the study have been or are candidates to receive CAR-T cell therapy. CAR T therapy is intended as a therapeutic pathway.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patients with relapsed/refractory non-Hodgkin lymphoma, candidates to receive CAR-T cell therapy according to clinical indication
• Acquisition of informed consent for participation in the study
• Acquisition of consent to the processing of personal data.

Exclusion Criteria:

none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop predictive models of response to CAR-T cell therapy at different time points in patients with relapsed/refractory non-Hodgkin lymphoma..	The outcome of objective 1 is the occurrence of one of the following conditions: complete response (CR) or partial response (PR) or stable response (SD) or progression of disease (PD). The outcome will be assessed by performing a PET/CT radiological examination. The response to treatment [(Overall Response Rate (ORR), or CR + PR] is defined as negativization of the uptake or Deauville score ≤3. The non-response to treatment/refractoriness [SD + PD] is defined as persistence/increase of the uptake, or Deuville Score >3.	1,3 ,6 12 months post CAR-T therapy
Develop a predictive model of CRS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma	The outcome of this objective is the occurrence of CRS toxicity events. The outcome will be assessed according to CTCAE vers. 5.0 CRS toxicity on treatment is defined as the incidence of CRS events of grade ≥1 and/or the incidence of ICANS of grade ≥1	7 days post CAR-T therapy
Develop a predictive model of ICANS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma	The outcome of this objective is the occurrence of ICANS toxicity events. The outcome will be assessed according to CTCAE vers. 5.0 ICANS toxicity on treatment is defined as the incidence of ICANS events of grade ≥1.	+7 days post CAR-T infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate the overall survival (OS) of patients with relapsed/refractory non-Hodgkin lymphoma who have undertaken the therapeutic pathway (i.e. from apheresis, by intention-to-treat)	Death from any cause	12 months post CAR-T infusion
To estimate the progression-free survival (PFS) of patients with relapsed/refractory non-Hodgkin lymphoma who have undertaken the therapeutic pathway (i.e. from apheresis, by intention-to-treat)	disease status by PET/CT examination and defined as negative uptake or Deauville score ≤3.	12 months post CAR-T infusion
To describe the characteristics of all therapy-related toxicity events (other than CRS and ICANS) in patients with relapsed/refractory non-Hodgkin lymphoma who received CAR-T cell therapy up to 12 months post-infusion.	Type, grade (according to CTCAE 5.0), onset date, end date, outcome	untill 12 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Pier Luigi Zinzani, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Car-T therapy
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: CLIO; RC-2024-2790609 (Other Grant/Funding Number: Ricerca Corrente (Ministero della salute))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No