Pulmonary Complications of CAR T-cell Therapy (CAR-T PULMOX)
Early and Late Pulmonary Complications of CAR T-cell Therapy
Background and Rationale Chimeric Antigen Receptor (CAR) T-cell therapies are emerging as a revolutionary treatment for hematological malignancies. However, this treatment carries a non-negligible clinical risk of pulmonary complications, which present as varied syndromes. These range from acute disorders, such as Cytokine Release Syndrome (CRS) with respiratory distress (ARDS), to interstitial lung diseases, as well as opportunistic and community-acquired infections related to treatment-induced immunosuppression. A better understanding of these pulmonary complications is necessary to identify predictive and risk factors. This knowledge is essential to guide the development of potential prevention strategies.
Objectives The primary objective of this study is to describe the early and late pulmonary complications associated with CAR T-cell therapies. The primary endpoint is the incidence and nature of pulmonary complications occurring early (≤30 days post-reinjection) and late (>30 days up to 2 years) after treatment.
Secondary objectives include:
- Investigating associations between patient characteristics or follow-up data and the onset of complications through exploratory analyses.
- Describing the prevalence of risk factors.
- Describing complication rates according to per-procedure data (e.g., pre-CAR-T lymphocyte count, duration of aplasia).
- Analyzing complication incidence by calendar periods of reinjection to study the evolution of practices.
- Describing survival curves based on different variables. Methods This is a descriptive, retrospective cohort study. The study will analyze data from all adult patients (expected n=266) who received CAR T-cell therapy at the Hematology Department of Lyon Sud Hospital (CHLS) and who have at least two years of follow-up data collected.
Patient data from January 9, 2017, to January 1, 2025, will be collected from medical records. Statistical analysis will include comparisons of continuous variables (Wilcoxon or Student's t-test) and categorical variables (Chi-squared or Fisher's exact test). Survival will be represented using Kaplan-Meier curves and compared with the Log-Rank test. Univariate and multivariate logistic regression models will be used to identify associations, with a Bonferroni correction applied for multiple tests.
Expected Outcomes The findings are expected to help identify predictive factors for pulmonary complications. This may lead to modified recommendations for pre-CAR-T cell assessments and adaptations to patient follow-up protocols.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pierre-Bénite, France
- Centre Hospitalier Lyon Sud
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
To be included in the study, patients must meet all of the following criteria:
- Be an adult (Majeur).
- Have received CAR T-cell based therapy.
- Received this therapy at the Hematology department of Lyon Sud (CHLS).
- Have a minimum of 2 years of follow-up data available at the time of the data collection start date.
Description
Inclusion Criteria:
• Be an adult (Majeur).
- Have received CAR T-cell based therapy.
- Received this therapy at the Hematology department of Lyon Sud (CHLS).
- Have a minimum of 2 years of follow-up data available at the time of the data collection start date.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patient who have received CAR-T cells therapy
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No intervention for the patient, study on medical records
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Describe the early and late pulmonary complications associated with CAR T-cell therapies
Time Frame: Day 0 through Day 720 after CAR-T cell injection with two pre-specified periods after CAR T-cell infusion: early, Day 0 through Day 30; late, Day 31 through Day 730 (2 years).
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incidence and nature of pulmonary complications occurring early (≤30 days post-reinjection) and late (>30 days up to 2 years) after treatment.
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Day 0 through Day 720 after CAR-T cell injection with two pre-specified periods after CAR T-cell infusion: early, Day 0 through Day 30; late, Day 31 through Day 730 (2 years).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 25-5347
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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