ClinicalTrials.gov
ClinicalTrials.gov Menu

Hematopoietic Stem Cell Transplant Survivors Study (HTSS Study) (HTSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02652052
Recruitment Status : Recruiting
First Posted : January 11, 2016
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
LaTonya J. Hickson, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Stem Cell Transplant Drug: Quercetin Other: Standard of Care - Observation Only Drug: Dasatinib Not Applicable

Detailed Description:
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 : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hematopoietic Stem Cell Transplant Survivors Study (HTSS Study)
Study Start Date : March 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group 1: Observational
Observational only
Other: Standard of Care - Observation Only
Control Arm - Observation only

Experimental: Group 2: Dasatinib & Quercetin
Interventional: The drugs dasatinib and quercetin will be used in this arm
Drug: Quercetin
Quercetin - take four 250mg capsules daily (total 1000 mg daily) for 3 consecutive days.

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




Primary Outcome Measures :
  1. Frailty [ Time Frame: Day 180 ]
    level of frailty as assessed by FRIED



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Adequate blood counts i.e. platelets>50,000 per microliter; HB>9/dL, and 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 GVHD treatments or for any other indication (e.g., imatinib for GIST, sorafenib for FLT3+ AML etc)
  • HSCT survivor with any post-transplant maintenance chemotherapy
  • Post-transplant relapse of cancer
  • Active progressive CHRONIC chronic or overlap GVHD (per the 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
  • Total bilirubin>2x upper limit normal (unless deemed to be due to Gilbert's syndrome); AST/ALT>2.5x ULN
  • 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.
  • QTc>450 msec. Common drugs that are well known in prolonging QTc include azithromycin, citalopram, escitalopram, fluconazole, and pentamidine. Baselines EKG will be obtained in each patient and if QTc >450 msec, then they will be excluded from the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652052


Contacts
Contact: Tammie Volkman, RN 507-266-1944 RSTDOMCTU@mayo.edu
Contact: Erin Wissler Gerdes 507-266-1944 wisslergerdes.erin@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tammie Volkman, RN    507-266-1944    RSTDOMCTU@mayo.edu   
Contact: Erin Wissler Gerdes    507-266-1944    wisslergerdes.erin@mayo.edu   
Principal Investigator: Mrinal S Patnaik, MBBS         
Principal Investigator: Nathan K LeBrasseur, MS, PhD         
Principal Investigator: Shahrukh K Hashmi, MD         
Principal Investigator: LaTonya Hickson, MN         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mrinal S Patnaik, M.B.B.S Mayo Clinic
Principal Investigator: Nathan K LeBrasseur, MS, PhD Mayo Clinic
Principal Investigator: Shahrukh K Hashmi, MD Mayo Clinic
Principal Investigator: LaTonya Hickson, MD Mayo Clinic

Responsible Party: LaTonya J. Hickson, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02652052     History of Changes
Other Study ID Numbers: 15-004683
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Dasatinib
Quercetin
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs