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NCT Number: NCT06156774

SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project

This is a multicenter prospective observational study lead by the FIL on sarcopenia and sGA as possible predictors of efficacy and toxicity outcomes in patients undergoing CAR-T cells treatment.

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Key information

Conditions

Non-hodgkin Lymphoma,B Cell Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C.D.U. Ematologia, Alessandria, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥ 18 years old).
  • Patients with B-cell non-Hodgkin Lymphoma scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug
  • Availability of a 18F-FDG PET/CT scan or a full dose CT scan (without contrast media) pre-treatment with CART
  • Written informed consent voluntarily provided

Exclusion criteria

  • Patients not fulfilling the eligibility criteria

Treatment and study plan

Chimeric Antigen Receptor T-cells (CAR-T) therapy

Other

Patients will be treated with CAR-T cell product as per routine clinical practice.

Primary outcomes

  1. Best Overall Response Rates (ORR)

    Time frame: up to 28 months

    Best Overall Response Rates (ORR) after CAR-T therapy according to the presence or absence of sarcopenic status

Secondary outcomes

  1. Best Complete Remission Rates (CRR)

    Time frame: up to 28 months

    Best Complete Remission Rates (CRR) after CAR-T therapy

  2. Progression-Free Survival (PFS)

    Time frame: up to 28 months

    Progression-Free Survival (PFS) at + 12 months after CAR-T therapy

  3. Overall Survival (OS)

    Time frame: up to 28 months

    Overall Survival (OS) at + 12 months after CAR-T therapy

  4. Incidence of CAR-T related toxicities

    Time frame: up to 28 months

    Incidence of CAR-T related toxicities (specifically: CRS, ICANS, cytopenias) in the different sarcopenic subgroups and, for patients ≥65 years old, according to their functional status

  5. Rate of admission to Intensive Care Units (ICU)

    Time frame: up to 28 months

    Rate of admission to Intensive Care Units (ICU) according to patients' sarcopenic and functional status

Study contacts

Contact information is provided by the study sponsor or research team.

Uffici Studi FIL

CONTACT

[email protected]

+390131033153

Uffici Studi FIL

CONTACT

[email protected]

+390599769910

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Collaborators

  • Kite, A Gilead Company

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2023
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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