NCT02652052

Brief Summary

The investigators hope to find the proof of principle concept from this pilot study so that the investigators can design a clinical trial based on the results of the explanatory hypothesis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

7.2 years

First QC Date

November 19, 2015

Last Update Submit

January 13, 2025

Conditions

Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

  • Frailty

    Evaluate the association of frailty with measures of senescence in HSCT survivors - level of frailty as assessed by FRIED

    Up to 180 days

Study Arms (2)

Group 1: Observational

OTHER

Standard of Care - Observation Only

Other: Standard of Care - Observation Only

Group 2: Dasatinib & Quercetin

EXPERIMENTAL

Interventional: The drugs dasatinib and quercetin will be used in this arm

Drug: Group 2: QuercetinDrug: Group 2: Dasatinib

Interventions

Standard of Care - Observation OnlyOTHER

Control Arm - Observation only

Group 1: Observational
Group 2: QuercetinDRUG

Quercetin - take four 250mg capsules daily (total 1000 mg daily) for 3 consecutive days.

Also known as: Quercetin
Group 2: Dasatinib & Quercetin
Group 2: DasatinibDRUG

Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days

Also known as: Dasatinib
Group 2: Dasatinib & Quercetin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Allogeneic HSCT patients surviving ≥ 1 year post-HSCT
  • Diagnosis of both malignant and non-malignant conditions as HSCT indications
  • HSCT survivors receiving any type of conditioning chemo/radiotherapy for HSCT
  • Ability to provide written and verbal informed consent
  • Age ≥ 18 years
  • Platelets \> 50,000 per microliter
  • Hemoglobin (HB) \> 9/dL
  • Absolute neutrophil count (ANC) \> 1000 per microliter

You may not qualify if:

  • HSCT survivor with human immunodeficiency virus (HIV) infection
  • HSCT survivor with active hepatitis B or C HSCT survivor on any TKI for either Philadelphia chromosome positive cancers or for graft versus host disease (GVHD) treatments or for any other indication (e.g., imatinib for gastrointestinal stromal tumor \[GIST\], sorafenib for FLT3+ acute myeloid leukemia \[AML\] etc)
  • HSCT survivor with any post-transplant maintenance chemotherapy
  • Post-(allogeneic) transplant relapse of cancer
  • Active progressive CHRONIC chronic or overlap GVHD (per the National Institute of Health \[NIH\] chronic GVHD criteria)
  • Presence of uncontrolled psychiatric disorder
  • Patient unable to give informed consent
  • Extremely poor overall prognosis (\<6 months as deemed by the primary transplant physician)
  • HSCT survivors with confirmed drug addiction
  • HSCT survivors with active coronary artery disease (CAD) \[including angina\] or active congestive heart failure (CHF)
  • International HSCT survivors in whom loss to follow-up would be a concern as deemed by primary transplant physician
  • Known hypersensitivity or allergy to dasatinib, or quercetin
  • Presence of uncontrolled lupus
  • Presence of uncontrolled pleural/pericardial effusions or ascites
  • Presence of active new cancer (solid or hematologic) except non-melanoma skin cancers
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

QuercetinDasatinib

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThiazolesSulfur CompoundsOrganic ChemicalsAzolesPyrimidines

Study Officials

  • Suzanne R. Hayman, M.D.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

January 11, 2016

Study Start

March 1, 2016

Primary Completion

May 23, 2023

Study Completion

May 23, 2023

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations

US(1)