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A volunteer subject with no known significant health problems who participates in research to test a new drug, device or intervention. These volunteers are recruited to serve as controls for patient groups. Healthy volunteers receive the same test, procedure, or drug the patient group receives.

Study phase

What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

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Search Results 1-10 of 24 for Bone marrow transplant

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  1. Study of Iomab-B Prior to HCT vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory AML

    Jacksonville, FL, Rochester, MN

    Study of Iomab-B Prior to HCT vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory AML

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      III
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Jacksonville, Fla.

    Open for enrollment

    		View complete study & contact information

    Rochester, Minn.

    Open for enrollment
    Print study details

    • Site IRB:

      • Jacksonville, Florida: 16-001301
      • Rochester, Minnesota: 16-001301

    • NCT ID:

      NCT02665065

    • Sponsor Protocol Number:

      Iomab-01

  2. Ixazomib Citrate, Pomalidomide, Dexamethasone, and Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Multiple Myeloma

    Rochester, MN

    Ixazomib Citrate, Pomalidomide, Dexamethasone, and Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Multiple Myeloma

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      II
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    This phase II trial studies how well ixazomib citrate, pomalidomide, dexamethasone, and stem cell transplantation works in treating patients with multiple myeloma that has come back or does not respond to treatment. Giving chemotherapy, such as pomalidomide and dexamethasone, before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving ixazomib citrate in addition to pomalidomide, dexamethasone, and stem cell transplantation may work better in treating patients with relapsed or refractory multiple myeloma.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 17-003292

    • NCT ID:

      NCT03202628

    • Sponsor Protocol Number:

      MC168A

  3. Digital Stories and Psychosocial Wellbeing in Stem Cell Transplant Patients

    Scottsdale/Phoenix, AZ

    Digital Stories and Psychosocial Wellbeing in Stem Cell Transplant Patients

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The proposed research will use a double-blind randomized controlled design to pilot test a model for how stories shared by a panel of HCT survivors impact the psychosocial well-being of the digital stories (DS) intervention condition of 55 patients who recently underwent HCT and their respective caregivers compared with 55 people in an information control (IC) condition and their caregivers (total 220 participants; N=110 per condition). Participants, recruited from the Mayo Clinic Arizona Cancer Center, will be randomly assigned to one of two conditions: the DS intervention or the IC video condition. Participants will questionnaires at baseline (T1), after the 4-week intervention (T2), and 3 months (100 days) later (T3).

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Scottsdale/Phoenix, Ariz.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Scottsdale/Phoenix, Arizona: 17-007602

    • NCT ID:

      NCT03440775

    • Sponsor Protocol Number:

      17-007602

  4. A Study to Evaluate Itacitinib for Low Risk Graft-vs-Host Disease (GVHD)

    Rochester, MN

    A Study to Evaluate Itacitinib for Low Risk Graft-vs-Host Disease (GVHD)

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      II
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this study is to test whether patients with low risk Great-vs-Host Disease (GVHD) can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD).

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 19-003577

    • NCT ID:

      NCT03846479

    • Sponsor Protocol Number:

      GCO 18-1684

  5. A Study of the Outcomes of Natalizumab plus Standard Steroid Treatment for High Risk Acute Graft-Versus-Host Disease

    Rochester, MN

    A Study of the Outcomes of Natalizumab plus Standard Steroid Treatment for High Risk Acute Graft-Versus-Host Disease

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      II
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this study is to assess the safety and effectiveness of combining the study drug Natalizumab (Tysabri®) with the standard use of steroid treatment, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft), treat the recipient's body as "foreign" and attack the cells in the recipient's body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. Acute GVHD can be severe and potentially fatal to the transplant recipient.

     

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 16-000650

    • NCT ID:

      NCT02133924

    • Sponsor Protocol Number:

      UMCC 2014.051

  6. Senescence in Chronic Kidney Disease

    Rochester, MN

    Senescence in Chronic Kidney Disease

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      II
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    Trials applying stem cells for the treatment of diabetic kidney disease (DKD) will soon be under way.  Autologous (from the patient) over allogeneic transplantation is the preferred option.  However, success with cellular therapy in DKD patients may be limited by a frailty phenotype and “unhealthy” stem cells due to cellular senescence.  The purpose of this study is to examine the effect of two drugs on mesenchymal stem cells, physical body function (or frailty), kidney function, and total clearance of senescent cells. Information from these investigations will help design preconditioning protocols for clinical trials applying stem cells for the treatment of DKD. 

    At present, we are enrolling participants with DKD, aged 40-80 years, and eGFR 15-45 mL/min/1.73m2. After screening and enrollment, study participants will be randomized to either the treatment or non-treatment (placebo) arm.  Participants in the treatment arm will take 2 drugs for 3 days.  For all participants, an olive-sized sample of subcutaneous fat will be taken from the abdomen for MSC isolation and repeated at day 14.  A frailty assessment along with blood and urine laboratory testing will be done at a total of 3 study visits (enrollment, day 14, and month 4).  Mail-out labs will be accepted for month 12 follow-up. 

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 15-005843

    • Sponsor Protocol Number:

      15-005843

  7. A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

    Scottsdale/Phoenix, AZ, Rochester, MN

    A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      III
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Scottsdale/Phoenix, Ariz.

    Open for enrollment

    		View complete study & contact information

    Rochester, Minn.

    Open for enrollment
    Print study details

    • Site IRB:

      • Scottsdale/Phoenix, Arizona: 17-003867
      • Rochester, Minnesota: 17-003867

    • NCT ID:

      NCT02997202

    • Sponsor Protocol Number:

      BMT-CTN-1506

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

    Rochester, MN

    Hematopoietic Stem Cell Transplant Survivors Study (HTSS Study)

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this 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.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 15-004683

    • NCT ID:

      NCT02652052

    • Sponsor Protocol Number:

      15-004683

  9. A Study to Assess Older Adults Applying Pre-transplant Comorbidity, Geriatric Assessment and Biomarkers to Predict Non-Relapse Mortality After Allogeneic Transplantation for Older Adults (CHARM)

    Rochester, MN

    A Study to Assess Older Adults Applying Pre-transplant Comorbidity, Geriatric Assessment and Biomarkers to Predict Non-Relapse Mortality After Allogeneic Transplantation for Older Adults (CHARM)

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    About this study

    The purpose of this study is to determine the set of assessments and biomarkers that could together constitute a robust and valid composite health risk model for accurate personalized estimation of one year NRM.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Open for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 19-004029

    • Sponsor Protocol Number:

      BMT CTN 1704

  10. A Study to Evaluate the Safety and Effectiveness of AMG 592 in Subjects With Steroid Refractory Chronic Graft Versus Host Disease

    Rochester, MN

    A Study to Evaluate the Safety and Effectiveness of AMG 592 in Subjects With Steroid Refractory Chronic Graft Versus Host Disease

    • Location:

      Interventional

      Describes the nature of a clinical study. Types include:

      • Observational study — observes people and measures outcomes without affecting results.
      • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
      • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

    • Study phase:

      I/II
      During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

    About this study

    The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of AMG 592 in subjects with steroid refractory cGVHD. Phase 2 - The purpose is to evaluate the effectiveness of AMG 592 in subjects with steroid refractory cGVHD as measured by ORR at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.

    Participating Mayo Clinic locations

    Study statuses change often. Please contact us for help.

    Mayo Clinic Location Status Contact

    Rochester, Minn.

    Closed for enrollment

    		View complete study & contact information
    Print study details

    • Site IRB:

      • Rochester, Minnesota: 18-007711

    • NCT ID:

      NCT03422627

    • Sponsor Protocol Number:

      20160283
.

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