Skip to main content
OpenTrials
Completed

NCT Number: NCT06026644

Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aou Di Bologna - Policlinico S. Orsola-malpighi - Uoc Ematologia, Bologna, Italy

Loading trial locations.

About this study

Quality of life assessment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Having any documented or psychiatric or neurological disorder which may interfere with self-reported HRQoL assessment.
  • Not able to read and understand local language.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire

    Time frame: at 12 months

    To assess the proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire

  2. The time to improvement in the PROMIS-Fatigue score

    Time frame: After 2 years from date of registration

    To assess the time to improvement in the PROMIS-Fatigue score

  3. The time to improvement in the EORTC QLQ-C30 questionnaires

    Time frame: After 2 years from date of registration

    To assess the time to improvement in the EORTC QLQ-C30 questionnaires

  4. The time to improvement in the QLQ-NHL-HG29 questionnaires

    Time frame: After 2 years from date of registration

    To assess the time to improvement in the QLQ-NHL-HG29 questionnaires

  5. 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

    To estimate the trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.

  6. 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

    To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.

  7. 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

    To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.

  8. 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

    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

  9. 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

    To investigate the impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.

  10. 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

    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.

  11. 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

    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.

  12. Factors predicting response to therapy and survival outcomes

    Time frame: After 2 years from date of registration

    To identify pretreatment factors predicting response to therapy and survival outcomes.

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study 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

Acronym: LNH012

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Sep 7, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.