Hematopoietic Stem Cell Transplant Survivors Study (HTSS)

January 13, 2025 updated by: Mayo Clinic

Hematopoietic Stem Cell Transplant Survivors Study (HTSS Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hematopoietic Stem Cell Transplant (HSCT) survivors are at an increased risk for premature aging. No one has evaluated the biologic markers of premature aging and senescence in HSCT survivors and their correlation with clinical outcomes, lifestyle, and nutrition. The investigators will evaluate age-related changes in HSCT survivors, with specified measures of premature aging, and employ therapeutic opportunities based on targeting senescent cells by conducting the first in-human pilot study of senolytic drugs (in HSCT survivors utilizing a combination of senolytics).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Presence of progeroid syndromes in family
  • Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies.
  • Creatinine clearance < 60 mL/min/1.73 m2 based on the Cockcroft-Gault
  • Inability to tolerate oral medications
  • Presence or history of significant liver disease with total bilirubin and/or alkaline phosphatase (ALP) > 2 x upper limit normal (unless deemed to be due to Gilbert's syndrome) or as per clinical judgement
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN) or as per clinical judgement
  • Active progressive ACUTE graft-versus-host disease
  • Active progressive OVERLAP graft-versus-host disease
  • Patients taking medications that are sensitive substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4(e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from infectious disease perspective, then they will be allowed only if the levels are therapeutic. Levels will be checked at baseline and also at day +4 post intervention
  • Patients taking H2-antagonists or proton pump inhibitors
  • Patients on therapeutic doses of anticoagulants (e.g. warfarin, heparin, low molecular weight heparin, factor Xa inhibitors etc)
  • On antiplatelet agents (e.g. full dose aspirin, clopidogrel etc.). Baby aspirin if absolutely necessary from cardiac perspective will be allowed.
  • On any quinolone antibiotic therapy for treatment or for prevention of infections.
  • Corrected QT (QTc) > 450 msec. Common drugs that are well known in prolonging QTc include azithromycin, citalopram, escitalopram, fluconazole, and pentamidine. Baselines electrocardiogram (EKG) will be obtained in each patient and if QTc > 450 msec, then they will be excluded from the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 2: Dasatinib & Quercetin
Interventional: The drugs dasatinib and quercetin will be used in this arm
Drug: Group 2: Quercetin
Quercetin - take four 250mg capsules daily (total 1000 mg daily) for 3 consecutive days.
Other Names:
  • Quercetin
Drug: Group 2: Dasatinib
Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days
Other Names:
  • Dasatinib
Other: Group 1: Observational
Standard of Care - Observation Only
Other: Standard of Care - Observation Only
Control Arm - Observation only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frailty
Time Frame: Up to 180 days
Evaluate the association of frailty with measures of senescence in HSCT survivors - level of frailty as assessed by FRIED
Up to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suzanne R. Hayman, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-004683
  • NCI-2021-14235 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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