Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life (LNH012)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Active, not recruiting

Conditions: DLBCL - Diffuse Large B Cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT06026644

GIMEMA _QoL _CAR-T

Details and patient eligibility

About

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.

Full description

Quality of life assessment

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

170 participants in 1 patient group

Quality of life assessment

Description:

Quality of life questionnaires