Impact of Targeted Therapy on Cancer-Related Impairment
18 Years and older, Male and Female
URCC-24060 (primary)
URCC-24060
URCC-24060
NCI-2025-04174
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.
Objectives
PRIMARY OBJECTIVE:
I. Characterize differences in subjective CRCI longitudinally among patients receiving TKIs for CML or CLL.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
GROUP II: Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study.
Eligibility
- * TKI RECIPIENTS: Participants must have a diagnosis of CML or CLL/SLL (i.e., small lymphocytic lymphoma)
* TKI RECIPIENTS: Participants must be scheduled to initiate TKI therapy for CML or CLL within 45 days or have initiated TKI therapy for CML or CLL within the previous 45 days
* Note: For this protocol, eligible therapies include (but are not limited to) TKI/BTKI agents (e.g., acalabrutinib, bosutinib, dasatinib, ibrutinib, imatinib, nilotinib, pirtobrutinib, ponatibib, zanabrutinib) as well as targeted therapies often used in combination with TKI/BTKI agents (e.g., asciminib, venetoclax). Any of these additional targeted therapy agents commonly used in treatment of CML/CLL can be used in combination therapy or monotherapy
* Note: Changes in TKI therapy, such as switching or adding TKI agents, during the enrollment window do not affect eligibility
* 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)
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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