Assessing DCog Short for Neurotoxicity in CAR-T

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT07403812
Status
Not Yet Recruiting

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Conditions

  • Hematologic Malignancy
  • Immune Effector Cell Associated Neurotoxicity Syndrome
  • Neurotoxicity
  • Neurotoxicity Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DCog Short — BEHAVIORAL
    An iPad-based cognitive assessment instrument to evaluate neurotoxicity and consisting of a series of tests that measure various aspects of cognitive function. After hospital discharge, participants will be provided with iPads which will be returned at the 90 day follow up visit.

Study Details

The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy.

Key Dates

Start date
Jul 31, 2026
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: CAR-T Cell Therapy Patients
    40 enrolled participants will complete: * Baseline visit * Daily study visits during hospitalization, then via phone: 2x weekly on days 14 - 21, then weekly on days 21 - 30 * 90 Day follow up visit

Primary Outcome Measure

Sensitivity of DCog Short for Early Detection of Neurotoxicity [ Time Frame: Until 30 days post CAR T-cell infusion, with frequency as described in the protocol schedule section 10.0. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jon Arnason, MD
[email protected]
(617) 667-9920
Jon Arnason, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Beth Israel Deaconess Medical Center· Boston, MA

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