Stem Cell TransplantPhase 1NCT02652052
Hematopoietic Stem Cell Transplant Survivors Study
A Phase 1 study testing Group 2: Quercetin and Group 2: Dasatinib in people with Stem Cell Transplant, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplant
- What is being tested?
- Group 2: Quercetin and Group 2: Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 23 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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).
- Conditions
- Stem Cell Transplant
- Being tested
- Standard of Care - Observation Only, Group 2: Quercetin, Group 2: Dasatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care - Observation OnlyOther
Control Arm - Observation only
Group 2: QuercetinDrug
Also called Quercetin
Quercetin - take four 250mg capsules daily (total 1000 mg daily) for 3 consecutive days.
Group 2: DasatinibDrug
Also called Dasatinib
Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Observational | Other | Standard of Care - Observation Only Receives: Other: Standard of Care - Observation Only |
| Group 2: Dasatinib & Quercetin | Experimental | Interventional: The drugs dasatinib and quercetin will be used in this arm Receives: Drug: Group 2: Quercetin; Drug: Group 2: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Evaluate the association of frailty with measures of senescence in HSCT survivors - level of frailty as assessed by FRIED
Measured: Up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start1 Mar 2016
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne R. Hayman, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652052
- Sponsor's protocol ID
- 15-004683
- Other IDs
- NCI-2021-14235
- Status last verified
- Jan 2025
- First submitted
- 19 Nov 2015
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematopoietic Stem Cell Transplant Survivors Study (HTSS Study)
- ClinicalTrials.gov ID
- NCT02652052
- Acronym / sponsor ID
- 15-004683
- Conditions
- Stem Cell Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Observational | Other | Other: Standard of Care - Observation OnlyStandard of Care - Observation Only |
| Group 2: Dasatinib & Quercetin | Experimental | Drug: Group 2: Quercetin, Drug: Group 2: DasatinibInterventional: The drugs dasatinib and quercetin will be used in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (29 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care - Observation OnlyControl Arm - Observation only | Other | Group 1: Observational |
| Group 2: QuercetinAlso: QuercetinQuercetin - take four 250mg capsules daily (total 1000 mg daily) for 3 consecutive days. | Drug | Group 2: Dasatinib & Quercetin |
| Group 2: DasatinibAlso: DasatinibDasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days | Drug | Group 2: Dasatinib & Quercetin |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Stem Cell Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Recruiting
Mosaic Trial for Stem Cell Transplant Recipients
Hematologic Malignancy, Stem Cell Transplant
Active, not recruitingObservational study
Delirium in Children Undergoing Stem Cell Transplantation
Stem Cell Transplant Complications, Delirium
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
RecruitingPhase 2/3
Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL
Acute Lymphoblastic Leukemia (ALL), Stem Cell Transplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne R. Hayman, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group 2: Quercetin and Group 2: Dasatinib in people with Stem Cell Transplant, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: Up to 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025; AzTrials last refreshed its copy on 3 Nov 2026.