DLBCL - Diffuse Large B Cell LymphomaLNH012NCT06026644
Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life
An observational study of DLBCL - Diffuse Large B Cell Lymphoma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 13 sites in Italy.
Trial summary
This study will ultimately aim at providing the scientific community with patient-reported health status data that will contribute facilitate decision-makings. Short- and long-term HRQoL and symptoms will be evaluated in a longitudinal fashion over time to improve the understanding of the impact of the disease and… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- How many people
- 170 participants
- Where
- 13 sitesItaly
- Study dates
- 29 Jun 2022to 15 Apr 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Aggressive B-Cell Lymphomas Treated with CAR-T Cell Therapy
Who may be able to join
- Patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed by indolent lymphoma and mantle cell lymphoma.
- Scheduled to received CAR-T cell product.
- Having a baseline PRO assessment.
- Adult patients (≥ 18 years old).
- Written informed consent provided.
Who cannot join
- Having any documented or psychiatric or neurological disorder which may interfere with self-reported HRQoL assessment.
- Not able to read and understand local language.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Aou Di Bologna - Policlinico S. Orsola-malpighi - Uoc Ematologia
Bologna
Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia
Brescia
AOU Careggi - SOD terapie cellulari e Medicina Trasfusionale
Florence
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
Genova
Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia
Milan
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Ad Indirizzo Oncologico
Palermo
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara
Aou Pisana - Uo Ematologia Universitaria
Pisa
Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
Roma
Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia
Rozzano
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza
About this study
Official title: Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life: A Multicenter Prospective Observational Study
This study will ultimately aim at providing the scientific community with patient-reported health status data that will contribute facilitate decision-makings. Short- and long-term HRQoL and symptoms will be evaluated in a longitudinal fashion over time to improve the understanding of the impact of the disease and CAR-T cell therapy on patients-wellbeing, symptom burden and daily functioning. This study will capture useful information on the impact of treatment toxicity, the burden of procedures on HRQoL outcomes. The planned collection of PRO and physician-reported adverse events ad early time point will help to compare and integrate these two points of view in healthcare assessment.
Read the detailed description
Quality of life assessment
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Quality of life assessment | Quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
To assess the proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
Measured: at 12 months
Secondary outcomes (12)
The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire
To assess the proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire
Measured: at 12 months
The time to improvement in the PROMIS-Fatigue score
To assess the time to improvement in the PROMIS-Fatigue score
Measured: After 2 years from date of registration
The time to improvement in the EORTC QLQ-C30 questionnaires
To assess the time to improvement in the EORTC QLQ-C30 questionnaires
Measured: After 2 years from date of registration
The time to improvement in the QLQ-NHL-HG29 questionnaires
To assess the time to improvement in the QLQ-NHL-HG29 questionnaires
Measured: After 2 years from date of registration
The trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.
To estimate the trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.
Measured: After 2 years from date of registration
The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.
To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.
Measured: After 2 years from date of registration
The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.
To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.
Measured: After 2 years from date of registration
Short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians.
To assess short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians
Measured: After + 10 day for infusion
The impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.
To investigate the impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.
Measured: After 2 years from date of registration
The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire.
To compare the long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire.
Measured: After 12 and 24 months from date of registration
The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire.
To compare the long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire.
Measured: After 12 and 24 months from date of registration
Factors predicting response to therapy and survival outcomes
To identify pretreatment factors predicting response to therapy and survival outcomes.
Measured: After 2 years from date of registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start29 Jun 2022
- Primary completion15 Feb 2024
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 170 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice Di Rocco, Principal investigator, Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026644
- Sponsor's protocol ID
- GIMEMA _QoL _CAR-T
- Acronym
- LNH012
- Status last verified
- May 2026
- First submitted
- 5 Jul 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Efficace F, Zinzani PL, Bonifazi F, Cutini I, Botto B, Chiappella A, Tisi MC, Bramanti S, Puglia S, Tartaglia F, Donzelli L, Farina M, Martino M, Gambella M, Ragaini S, Orciuolo E, Martelli M, Corradini P, Fazi P, Vignetti M, Di Rocco A. Real-world patient-reported symptomatic adverse events and concordance with physician assessments after CAR T-cell therapy in patients with aggressive B-cell lymphomas: a prospective study. Lancet Haematol. 2026 Jul;13(7):e460-e470. doi: 10.1016/S2352-3026(26)00128-6. Epub 2026 Jun 12.
PubMed 42285114
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life: A Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06026644
- Acronym / sponsor ID
- LNH012 / GIMEMA _QoL _CAR-T
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 7 Sep 2023 (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.
This study will ultimately aim at providing the scientific community with patient-reported health status data that will contribute facilitate decision-makings. Short- and long-term HRQoL and symptoms will be evaluated in a longitudinal fashion over time to improve the understanding of the impact of the disease and CAR-T cell therapy on patients-wellbeing, symptom burden and daily functioning. This study will capture useful information on the impact of treatment toxicity, the burden of procedures on HRQoL outcomes. The planned collection of PRO and physician-reported adverse events ad early time point will help to compare and integrate these two points of view in healthcare assessment.
Detailed description
Quality of life assessment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life assessment | – | –Quality of life questionnaires |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Aggressive B-Cell Lymphomas Treated with CAR-T Cell Therapy
Key inclusion criteria (5 listed)
- Patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed by indolent lymphoma and mantle cell lymphoma.
- Scheduled to received CAR-T cell product.
- Having a baseline PRO assessment.
- Adult patients (≥ 18 years old).
- Written informed consent provided.
Key exclusion criteria (2 listed)
- Having any documented or psychiatric or neurological disorder which may interfere with self-reported HRQoL assessment.
- Not able to read and understand local language.
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
The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
Time frame: at 12 months
To assess the proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
12 secondary outcomes
The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire
Time frame: at 12 months
The time to improvement in the PROMIS-Fatigue score
Time frame: After 2 years from date of registration
The time to improvement in the EORTC QLQ-C30 questionnaires
Time frame: After 2 years from date of registration
The time to improvement in the QLQ-NHL-HG29 questionnaires
Time frame: After 2 years from date of registration
The trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.
Time frame: After 2 years from date of registration
The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.
Time frame: After 2 years from date of registration
The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.
Time frame: After 2 years from date of registration
Short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians.
Time frame: After + 10 day for infusion
The impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.
Time frame: After 2 years from date of registration
The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire.
Time frame: After 12 and 24 months from date of registration
The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire.
Time frame: After 12 and 24 months from date of registration
Factors predicting response to therapy and survival outcomes
Time frame: After 2 years from date of registration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Derived from this study: PubMed 42285114Efficace F, Zinzani PL, Bonifazi F, Cutini I, Botto B, Chiappella A, Tisi MC, Bramanti S, Puglia S, Tartaglia F, Donzelli L, Farina M, Martino M, Gambella M, Ragaini S, Orciuolo E, Martelli M, Corradini P, Fazi P, Vignetti M, Di Rocco A. Real-world patient-reported symptomatic adverse events and concordance with physician assessments after CAR T-cell therapy in patients with aggressive B-cell lymphomas: a prospective study. Lancet Haematol. 2026 Jul;13(7):e460-e470. doi: 10.1016/S2352-3026(26)00128-6. Epub 2026 Jun 12.
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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. This study is not recruiting at the moment.
Alice Di Rocco principal investigator
Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DLBCL - Diffuse Large B Cell Lymphoma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 13 sites 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06026644, which also lists 1 linked publication.
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 10 Jun 2026.