RecruitingNCT07638007

Impact of Targeted Therapy on Cancer-Related Cognitive Impairment

Sponsor

University of Rochester NCORP Research Base

Enrollment

400 participants

Start Date

Nov 21, 2025

Study Type

OBSERVATIONAL

Conditions

Chronic Lymphocytic Leukemia (CLL)Chronic Myeloid Leukemia, BCR-ABL1 Positive Disease/Condition Name Cancer-related Cognitive Dysfunction

Summary

This study examines whether there are differences in brain health or well-being in patients receiving TKI therapy for leukemia compared to individuals who do not receive TKI therapy.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

TKI RECIPIENTS: Participants must have a diagnosis of CML or CLL
TKI RECIPIENTS: Participants must be scheduled to receive their first dose of TKI therapy for CML or CLL within 30 days or have received their first dose of TKI therapy for CML or CLL within the previous 30 days
TKI RECIPIENTS: Participants must be ≥ 18 years of age
TKI RECIPIENTS: Participants must be able to speak and read English
TKI RECIPIENTS: Participants must be able to understand and willing to sign an informed consent document
CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be ≥ 18 years of age
CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to speak and read English
CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to understand and willing to sign an informed consent document
CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Each participant must be matched to a TKI recipient participant based on sex and age ±5 years (i.e., must be no more than 5 years older or younger than the TKI recipient participant)

Exclusion Criteria10

Participants must have no history of metastatic cancer, primary brain tumor, or brain irradiation
Participants must have no history of TKI therapy
Participants must have no history of cytotoxic chemotherapy, immune checkpoint inhibitor therapy, hormonal therapy, biologic therapy, radiotherapy within the past 5 years. However, permitted treatments include prior use of hydroxyurea for the treatment of CML or CLL as well as treatment with obinutuzumab or rituximab concurrent with TKI therapy for CLL
Participants must have no history of stroke within the past year and no remaining cognitive symptoms from any stroke prior to the past year
Participants must have no history of head trauma with loss of consciousness within the year prior to consent
Participants must have no diagnosis of dementia or severe neurodegenerative disease impairing daily functioning
Participants must have no psychiatric condition that led to hospitalization within the past year
Participants must not be currently pregnant
Participants must not be colorblind based on self-report
Participants must not be study staff who have previously viewed or administered the objective cognitive function measures (e.g., CANTAB)