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

NCT06026644 | Active Not Recruiting

• 1 other identifier: GIMEMA _QoL _CAR-T
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 13

Brief 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 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.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

  at 12 months

Secondary Outcomes (12)

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

  at 12 months

• The time to improvement in the PROMIS-Fatigue score

  After 2 years from date of registration

• The time to improvement in the EORTC QLQ-C30 questionnaires

  After 2 years from date of registration

• The time to improvement in the QLQ-NHL-HG29 questionnaires

  After 2 years from date of registration

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

  After 2 years from date of registration

Study Arms (1)

Quality of life assessment

Quality of life questionnaires

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Aggressive B-Cell Lymphomas Treated with CAR-T Cell Therapy

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (13)

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

Bologna, Italy

Location

Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia

Brescia, Italy

Location

AOU Careggi - SOD terapie cellulari e Medicina Trasfusionale

Florence, Italy

Location

Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti

Genova, Italy

Location

Fondazione Irccs "Istituto Nazionale Tumori" - Milano - Sc Ematologia

Milan, Italy

Location

Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Ad Indirizzo Oncologico

Palermo, Italy

Location

Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica

Pescara, Italy

Location

Aou Pisana - Uo Ematologia Universitaria

Pisa, Italy

Location

Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia

Roma, Italy

Location

Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia

Rozzano, Italy

Location

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

Torino, Italy

Location

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2

Torino, Italy

Location

Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

Vicenza, Italy

Location

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Alice Di Rocco

  Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: September 7, 2023
• Study Start: June 29, 2022
• Primary Completion: February 15, 2024
• Study Completion: April 15, 2026
• Last Updated: July 25, 2024

Record last verified: 2023-07

Locations

IT (13)