Status:
ACTIVE_NOT_RECRUITING
An Open-Label Intervention Trial to Reduce Senescence and Improve Frailty in Adult Survivors of Childhood Cancer
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Frailty
Childhood Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a first-in survivor pilot study with the goal of establishing preliminary evidence of efficacy, safety, and tolerability of two senolytic regimens to reduce markers of cellular senescence (pri...
Detailed Description
Eligible subjects who meet inclusion criteria will be randomized, stratified on sex, 1:1 and age ( ≥40 vs \< 40) to receive Dasatinib (100 mg/day) plus Quercetin (500 mg twice daily) on days 1, 2, 3, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04733534
Start Date
June 6 2022
End Date
December 1 2027
Last Update
August 14 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105