Status:
RECRUITING
Non-Pharmacological Interventions for Neurotoxicity in Hematologic Patients Receiving CAR-T Therapy
Lead Sponsor:
Instituto de Investigacion Sanitaria INCLIVA
Conditions:
Hematologic Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if two non-pharmacological strategies can help reduce neurotoxicity caused by CAR-T cell therapy in adult patients with hematologic cancer, both sexes, aged...
Detailed Description
A parallel-group, multicenter and randomized controlled clinical trial will be conducted from July 2025 to July 2027. The study will evaluate the effectiveness of two non-pharmacological interventions...
Eligibility Criteria
Inclusion
- Male and female patients, aged 18 to 80 years.
- Diagnosed with a hematological condition.
- Initiating antineoplastic treatment with CAR-T cell therapy.
Exclusion
- Presence of language barriers or physical and/or cognitive impairments that hinder the understanding of the interventions or prevent proper completion of the assessment tools used in the study.
- Pre-existing neurological or psychiatric comorbidities that may interfere with the evaluation of neurotoxic effects of the hematologic treatment.
- Concomitant treatment with additional neurotoxic drugs not related to the study protocol.
- History of abusive consumption of neurotoxic substances.
Key Trial Info
Start Date :
July 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07173166
Start Date
July 6 2025
End Date
September 1 2028
Last Update
September 15 2025
Active Locations (2)
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1
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain, 46010
2
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026