Impact of Targeted Therapy on Cancer-Related Cognitive Impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares cognitive function and well‑being between patients with CML or CLL receiving tyrosine kinase inhibitor (TKI) therapy and cancer‑free controls. Participants in both groups complete surveys, undergo cognitive assessments, provide saliva samples, and have medical records reviewed over time. The study groups are matched by sex and age, and follow‑up assessments characterize longitudinal differences in cancer‑related cognitive impairment. No interventions are tested; the design relies on observational comparisons.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• University of Rochester NCORP Research Base
  Rochester, New York, United States Recruiting

Study contacts

• Study coordinator: Ashley Mack, MS
• Email: URCC_24060@urmc.rochester.edu
• Phone: 585-275-1090

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ibrutinib and Venetoclax in CLL/SLL: Long-Term Outcomes After Frontline CAPTIVATE

  This study follows people with CLL or SLL who previously received the ibrutinib plus venetoclax combination in CAPTIVATE to see how they do over time and what treatments they need if the disease returns.

  Recruiting European Research Initiative on CLL · Milan · NCT07774390

• BTK degrader plus BCL-2 inhibitor in untreated CLL/SLL

  This phase 2 study tests whether the BTK degrader BGB-16673 together with sonrotoclax can help people with newly diagnosed CLL/SLL.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07508995

• Immune profiling during first-line pirtobrutinib treatment for CLL/SLL

  This will test pirtobrutinib as a first treatment for adults with CLL or SLL and see how it changes immune cells in the blood and lymph nodes.

  Recruiting Early Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07428707

• NX-5948 treatment for adults with CLL or SLL after prior BTK and BCL-2 inhibitor therapy

  NX-5948, an oral BTK degrader, will be tried to see if it helps adults with relapsed or refractory CLL or SLL who have already been treated with both BTK and BCL-2 inhibitors.

  Recruiting at 43 sites Phase 2 Nurix Therapeutics, Inc. · Phoenix, Arizona and 42 other locations · NCT07221500

• GT801 injection for adults with relapsed/refractory CD19-positive B-cell cancers and autoimmune hemolytic anemia

  This trial will test whether GT801 injections help adults with CD19-positive B-cell cancers (B-ALL, CLL, B-NHL) or autoimmune hemolytic anemia that have returned or not responded to prior treatments.

  Recruiting Early Phase 1 Grit Biotechnology · Zhengzhou, Henan and 1 other locations · NCT07205315

• Quality of life and symptom changes over two years in adults with CLL or SLL starting targeted therapy

  This study will see how quality of life, fatigue, and symptoms change over two years for adults with CLL or SLL who start treatment with a BTK inhibitor versus a BCL2 inhibitor.

  Recruiting H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07030400

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.