Are quality of life data reported in clinical trials evaluating CAR T cells in hematologic malignancies?

BACKGROUND

Increasing indications for CAR T cells in early-line hematological malignancies underscore the need to report patient experiences. However, data regarding patient quality of life in this setting remain limited.

OBJECTIVE

This study aimed to assess the inclusion of Health-Related Quality of Life as an endpoint in clinical trials registered on ClinicalTrials.gov for CAR T-cell therapies in hematological malignancies.

METHODS

A comprehensive search of the U.S. National Institutes of Health database (ClinicalTrials.gov) was performed for trials registered up to August 28, 2022, using the keywords "CAR" AND ("lymphoma" OR "multiple myeloma" OR "leukemia" OR "hematologic malignancy"). For each selected trial, data regarding study design, setting, indication, treatment line, relevant outcomes, and evaluation scales were collected.

MAIN

RESULTS

Out of 1281 records, 429 trials met the inclusion criteria and were analyzed, with over half being phase 1. The most common primary endpoint was safety (47%). Health-Related Quality of Life was assessed as a secondary endpoint in only 11% of trials. A wide variety of questionnaires were identified, and data collection methodologies (baseline assessments, timepoints, and follow-up duration) varied considerably across studies.

CONCLUSION

Establishing a standardized consensus for measuring Health-Related Quality of Life is essential to complement efficacy data in clinical trials and real-world studies evaluating CAR T-cell therapies.