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

NCT06720701 | Not Yet Recruiting

• 2 other identifiers: CLIORC-2024-2790609
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Hodgkin Lymphoma

Keywords

Car-T therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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)

  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)

  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.

  untill 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pier Luigi Zinzani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+39 0512143680; pierluigi.zinzani@unibo.it

Beatrice Casadei, MD

CONTACT

+39 0512143680; beatrice.casadei10@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)