Non-Hodgkin LymphomaCLIONCT06720701
Development of Prognostic Models for Response and Toxicity to CAR-T Cell Therapy in Patients with Relapsed/refractory Non Hodgkin's Lymphoma.
An observational study of Non-Hodgkin Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Bologna, 40138
Pier Luigi Zinzani, +390512144042, pierluigi.zinzani@unibo.it
Beatrice Casadei, MD, +39 0512143680, beatrice.casadei10@unibo.it
About this study
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
Read the 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.
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Car-T therapy
- Medical subject headings
- Lymphoma, Non-Hodgkin
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: +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)
Death from any cause
Measured: 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.
Measured: 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
Measured: untill 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study startDec 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720701
- Sponsor's protocol ID
- CLIO
- Other IDs
- RC-2024-2790609
- Acronym
- CLIO
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Prognostic Models for Response and Toxicity to CAR-T Cell Therapy in Patients with Relapsed/refractory Non Hodgkin's Lymphoma.
- ClinicalTrials.gov ID
- NCT06720701
- Acronym / sponsor ID
- CLIO / CLIO
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Car-T therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop predictive models of response to CAR-T cell therapy at different time points in patients with relapsed/refractory non-Hodgkin lymphoma..
Time frame: 1,3 ,6 12 months post CAR-T therapy
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.
Develop a predictive model of CRS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma
Time frame: 7 days post CAR-T therapy
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
Develop a predictive model of ICANS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma
Time frame: +7 days post CAR-T infusion
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.
3 secondary outcomes
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)
Time frame: 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)
Time frame: 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.
Time frame: untill 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier Luigi Zinzani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Zinzani, MD (+39 0512143680, pierluigi.zinzani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop predictive models of response to CAR-T cell therapy at different time points in patients with relapsed/refractory non-Hodgkin lymphoma.. (time frame: 1,3 ,6 12 months post CAR-T therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.