Peer-reviewedCC BYHematology, transfusion and cell therapy8 Oct 2026

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

Julie Bouaziz-Bohbot¹
Lionel Karlin²
Gilles A Salles³
Catherine Rioufol⁴

4 affiliations

¹Lyon I University, EA 3738 - CICLY, Lyon Sud University, Lyon, France.
²Hematology Department, Lyon Sud Hospital, Hospices Civils de Lyon, France.
³Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, NY, United States.
⁴Lyon I University, EA 3738 - CICLY, Lyon Sud University, Lyon, France; Clinical Oncology Pharmacy Unit, Lyon Sud Hospital, Hospices Civils de Lyon, France. Electronic address: [email protected].

Abstract

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.

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Cite

BibTeX RIS

BibTeX

@article{bouazizbohbot2026quality,
  title = {{Are quality of life data reported in clinical trials evaluating CAR T cells in hematologic malignancies?}},
  author = {Julie Bouaziz-Bohbot and Lionel Karlin and Gilles A Salles and Catherine Rioufol},
  journal = {Hematology, transfusion and cell therapy},
  year = {2026},
  month = oct,
  doi = {10.1016/j.htct.2026.108542},
  url = {https://europepmc.org/article/MED/42849369},
  note = {CC BY},
}

RIS

TY  - JOUR
TI  - Are quality of life data reported in clinical trials evaluating CAR T cells in hematologic malignancies?
AU  - Julie Bouaziz-Bohbot
AU  - Lionel Karlin
AU  - Gilles A Salles
AU  - Catherine Rioufol
PY  - 2026
DA  - 2026/10/08
JO  - Hematology, transfusion and cell therapy
DO  - 10.1016/j.htct.2026.108542
UR  - https://europepmc.org/article/MED/42849369
AB  - 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.
SN  - 2531-1379
SN  - 2531-1387
ER  -