About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with a diagnosis of CML or CLL scheduled to receive first dose of TKI therapy within 30 days or have received first dose of TKI within the previous 30 days, as well as cancer-free individuals.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Subjective cognitive performance
Will be assessed using the FACT-Cog. Will apply multilevel models to study data. Will include main effects of time, group, and the group X time interaction.
Sponsors and contacts
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University of Rochester NCORP Research Base
Lead sponsor
National Cancer Institute (NCI)
Collaborator