Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT04733534
Eligibility Criteria:
Inclusion Criteria:
* Participant in SJLIFE and \> 5 years from diagnosis.
* ≥18 years of age.
* Frail (2 of 4 objectively measured Fried criteria adapted,(excluding self-reported fatigue as a criteria), including abnormal walking speed; muscle strength; activity level; and muscle mass). See Section 5 for details.
* CD3+ T lymphocytes: p16INK4A detected at \<34 cycles by RT PCR.
* Agrees to use contraception as Dasatinib is teratogenic.
* Female participant has a negative pregnancy test.
* QTc \<450 milliseconds in electrocardiogram.
* Able to take oral medications.
Exclusion Criteria:
* Currently has HIV, Hepatitis B/C, invasive fungal infection
* Anemia or as per clinical judgement.
* Hypersensitivity to study drugs
* New/active malignancy/taking chemotherapy and/or radiation except non-melanoma skin cancers
* Currently taking medications that inhibit or induce CYP3A4 or that are sensitive to substrates or substrates with a narrow therapeutic range for CYP2C8, CYP2C9, or CYP2D6.
* Taking anticoagulants or antimicrobial agents
* Currently taking Quercetin or Fisetin
* Pregnant or nursing at time of enrollment/during the study
* Impaired cognition or motor performance due to congenital defects
* Currently participating in another research intervention to aid walking speed or other measures of frailty including muscle strength; low activity; muscle mass or exhaustion/fatigue
* Participant is a Non-English Speaker
* Uncontrolled pleural/pericardial effusion or ascites
* Subjects on anticoagulant or antiplatelet agents (Warfarin, Clopidogrel \[Plavix\]; Dipyridamole + Aspirin \[Aggrenox\]; Ticagrelor \[Brilintal\]; Prasugrel \[Effient\]; Ticlopidine \[Ticlid\]; or other) who are unable or unwilling to reduce or hold therapy prior to and during the 2-3 day drug dosing. Subjects may continue their previous regimen after drug dosing is complete.
* Cognitive impairment defined by IQ \<80
* Diagnosis of a psychotic disorder
* Laboratory tests as indicated or as per clinical judgement
* Severe hepatic dysfunction with ALT/AST \> 3 times upper limit of normal.
* Total bilirubin \> 2 times upper limit of normal.
* eGFR \<25 ml/min/1.73m2 or as per clinical judgement.
* Hemoglobin \< 7 g/dl; white blood cell count ≤2,000/mm3 (≤2.0 x 109/L) or ≥20,000/mm3 (≥20 x 109/L); platelet count ≤40,000/μL (≤40 x 109/L); absolute neutrophil count ≤1 x 109/L; lymphocyte count \<0.3 x 109/L at screening as a marker of poor nutrition
* Fasting glucose \>300.
* Participant is unable to ambulate
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04733534
Study Brief:
Protocol Section:
NCT04733534