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Senolytic

Senolytic Therapy for Frailty

Phase 2

Recruiting

Led By Gregory T. Armstrong, MD, MSCE

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant in SJLIFE and > 5 years from diagnosis

CD3+ T lymphocytes: p16^INK4A detected at <33 cycles by RT PCR

Must not have

Taking anticoagulants or antimicrobial agents

New/active malignancy/taking chemotherapy and/or radiation except non-melanoma skin cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 150

Awards & highlights

No Placebo-Only Group

Summary

This trial will test two different senolytic therapies to see if they are effective in reducing senescent cells and improving frailty. The primary endpoints are change in walking speed and senescent cell abundance.

Who is the study for?

Adults who survived childhood cancer and are now frail (meeting at least 3 of 5 specific health criteria), over 18 years old, more than 5 years post-diagnosis, with certain blood markers. They must be able to take oral meds, not pregnant or nursing, agree to use contraception due to teratogenic risks of Dasatinib, have no severe heart issues or anemia, and not on conflicting medications.

What is being tested?

The trial is testing two treatments aimed at reducing cell aging and improving physical function in adult survivors of childhood cancer. One group will receive a combination of drugs called Dasatinib plus Quercetin; the other will get Fisetin alone. The main goals are better walking speed and fewer senescent cells in the blood.

What are the potential side effects?

Possible side effects include increased risk for infections due to weakened immune system responses from Dasatinib; gastrointestinal issues like nausea or diarrhea; potential allergic reactions; fatigue; changes in liver enzymes which might indicate liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am part of SJLIFE and was diagnosed over 5 years ago.

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My test shows low levels of a specific protein in my immune cells.

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I am 18 years old or older.

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I am considered frail due to issues with walking speed, muscle strength, activity level, muscle mass, and fatigue.

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My hemoglobin level is above the required minimum for my gender.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking blood thinners or antibiotics.

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I am not currently receiving treatment for any cancer except non-melanoma skin cancers.

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I am currently taking Quercetin or Fisetin.

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I have HIV, Hepatitis B/C, or an invasive fungal infection.

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I have anemia.

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I have cognitive or motor issues due to birth defects.

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I have fluid buildup that isn't being managed around my lungs or heart, or in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 150

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 150

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 150 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Walking Speed

Change in walking speed

Senescent cell abundance in blood (p16INK4A)

Secondary study objectives

Safety of two different senolytic therapies as assessed by treatment-related adverse events using CTCAE v5.0

Tolerability of two different senolytic therapies as assessed by treatment-related adverse events using CTCAE v5.0

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Dasatinib plus QuercetinActive Control1 Intervention

Day 0 (30 per arm, randomization stratified by sex and age) At the visit on day 7, blood CD3+ T lymphocyte p16\^INK4A mRNA and other markers of inflammation and senescence will be accessed to verify that senescent cells have been cleared by the intervention. Post-treatment follow-up will occur on days 60 for (primary endpoints) and day 150 for secondary evaluation. Day 150 will assess the permanence of change after completion of the trial.

Group II: FisetinActive Control1 Intervention

Day 0 (30 per arm, randomization stratified by sex and age) At the visit on day 7, blood CD3+ T lymphocyte p16INK4A mRNA and other markers of inflammation and senescence will be accessed to verify that senescent cells have been cleared by the intervention. Post-treatment follow-up will occur on days 60 for (primary endpoints) and day 150 for secondary evaluation. Day 150 to will assess the permanence of change after completion of the trial.

0 / 12Eligibility criteria met