Clinical Trials

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60 studies in Division of Hematology Research

  1. Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients With Relapsed or Refractory B Cell Malignancies

    Rochester, Minn. View Summary

    Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients With Relapsed or Refractory B Cell Malignancies

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, B cell lymphoma and plasma cell leukemia.

    NCT ID:

    NCT01435720

    IRB Number:

    11-002766

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Referral Office 507-538-7623
                        


  2. A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

    Rochester, Minn. View Summary

    A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - Determine the impact of the intervention program (IP) on adherence to mercaptopurine (6MP) using the following adherence assessments: Frequency of 6MP dosing using MEMS (primary measure of adherence); 6MP dosage- and thiopurine methyltransferase (TPMT)-normalized serial red blood cell (RBC) thioguanine nucleotide (6TGN) levels; and self-report of adherence. Secondary - Examine the modifying effect of socio-demographic and clinical characteristics as well as health beliefs/knowledge on changes in adherence with the IP. OUTLINE: This is a multicenter study. Patients are stratified according to ethnic background (Hispanic vs non-Hispanic white vs African-American). Patients are randomized to 1 of 2 intervention arms. - Arm I: Patients receive the Patients Supply Kit containing an electronic pill monitoring system, a Medication Event Monitoring Systems (MEMS®) medication bottle with TrackCap™ with standard resistant cap, and written instructions for the patient and pharmacist. Parents and/or caregivers are also trained to supervise patients' intake of the medication. Beginning on day 1, patients start using the MEMS® medication bottle with TrackCap™ . Clinical research assistants contact patients and parents by telephone the next day to confirm that TrackCap™ is being used, to identify any obstacles, and to determine solutions. Beginning on day 29, patients and caregivers view an interactive multimedia educational program on-line or via DVD. Patients also receive a customized electronic mercaptopurine schedule and automated customized text message reminders delivered via cellular phone or web-based interface. Patients and caregivers are instructed to return the MEMS® medication bottle with TrackCap™ to the clinic by day 141. - Arm II: Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. Patients and parents and/or caregivers in both arms complete the Demographic and the Acculturation Questionnaires on day 1. Patients and/or caregivers in arm I also complete the Adherence Questionnaires on days 29, 57, and 141 and the Intervention Rating Questionnaire on day 141. Blood samples are collected on days 1, 29, 57, and 141 for thiopurine methyltransferase phenotyping and thioguanine nucleotide levels by high-performance chromatography.

    NCT ID:

    NCT01503632

    IRB Number:

    12-004675

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        


  3. A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

    Rochester, Minn. View Summary

    A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin will not be used as a single-agent comparator in countries that do not permit its use at this time.

    NCT ID:

    NCT01482962

    IRB Number:

    12-004061

    Who can I contact for additional information about this study?

  4. Exploring the Potential of Dual Kinase JAK 1/2 Inhibitor Ruxolitinib (INC424) With Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

    Phoenix/Scottsdale, Ariz. View Summary

    Exploring the Potential of Dual Kinase JAK 1/2 Inhibitor Ruxolitinib (INC424) With Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    A two- stage Simon Phase II study will be conducted in each of two groups of patients: related and unrelated donor transplants. In each donor transplant group, the first stage of this design will include 11 patients evaluated for death or graft failure by 100 days post-transplant. In each stratum, we will enroll additional patients (up to 20%) of stratum total to take into account exclusions due to donor failure (such as donor deemed unsuitable for stem cell donation due to medical or other reasons) only. Those patients who have toxicities related to Ruxolitinib and not been able to reach HCT due to these toxicities will be included in the estimation of overall failure rates. Only those patients who are excluded based on donor related issues without any regimen related complications will be excluded from the estimation of failure rates. However, all data on these patients will be reported.

    NCT ID:

    NCT01790295

    IRB Number:

    13-003340

    Who can I contact for additional information about this study?


    Scottsdale: Clinical Trials Office All Mayo Clinic Locations 507-538-7623
                        

  5. A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function

    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Multiple Myeloma (MM) affects approximately 20,000 Americans annually and remains an incurable hematologic malignancy characterized by frequent early response followed by universal treatment relapse necessitating multiple sequential therapeutic regimens. Until recently, few effective therapies existed. Several novel agents for MM have now become available including the immunomodulatory drugs thalidomide, lenalidomide, as well as the proteasome inhibitor, bortezomib. Each of these agents is undergoing extensive clinical evaluation in combination with other therapies to produce unprecedented response rates in newly diagnosed and relapsed MM. Lenalidomide has proven to be a highly effective treatment agent, particularly when used in combination with dexamethasone but is renally excreted and little information is available about its use in myeloma patients with impaired kidney function (20% have renal failure at some time after diagnosis). Defining a safe and effective dose of lenalidomide to use is a critical step in MM treatment. OUTLINE: This is a Phase I, dose-escalation study of lenalidomide followed by a Phase II study. Patients are stratified according to degree of renal dysfunction (moderate [creatinine clearance 30-60 mL/min] vs severe [creatinine clearance <30 mL/min and does not require dialysis] vs end-stage renal disease [creatinine clearance <30 mL/min and requires dialysis]). Patients receive oral lenalidomide on days 1-21 and low-dose oral dexamethasone 40 mg on days 1, 8, 15, and 22. There is a 7 day rest (days 22-28) from lenalidomide. Each cycle is 28 days and repeated in the absence of disease progression or unacceptable toxicity. Patients enrolled in the phase II portion of the study will undergo blood sample collection periodically for pharmacokinetic analysis of lenalidomide (Mayo Clinic sites only). After completion of study treatment, patients are followed every 6 months for up to 3 years.

    NCT ID:

    NCT00790842

    IRB Number:

    08-003156 11-002048

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        
    Scottsdale: Mayo Clinic Clinical Trials Office 507-538-7623
                        

  6. Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma

    Rochester, Minn. View Summary

    Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - To determine the maximum tolerated dose of lenalidomide when given in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in patients with newly diagnosed stage II-IV diffuse large cell or grade 3 follicular B-cell lymphoma. (Phase I) - To assess the efficacy of this regimen, in terms of event-free survival and response rate, in these patients. (Phase II) - To assess the safety of this regimen in these patients. (Phase II) Secondary - To assess the host immune function at baseline and after treatment and correlate these parameters with tumor response and event-free survival. OUTLINE: This is a multicenter, phase I dose-escalation study of lenalidomide followed by a phase II study. - Phase I: Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisone on days 1-5, and oral lenalidomide on days 1-10. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. - Phase II: Patients receive lenalidomide at the maximum tolerated dose determined in phase I and rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and pegfilgrastim as in phase I. Blood is collected at baseline, before course 3, and after completion of study treatment for translational research studies. Research studies include immune function and cytokine analysis, T- and B- quantitative lymphocyte analysis, and single nucleotide polymorphism analysis. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

    NCT ID:

    NCT00670358

    IRB Number:

    07-007992

    Who can I contact for additional information about this study?

  7. Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma

    Rochester, Minn. View Summary

    Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES:

           -  To determine the clinical features, treatment, and outcome of patients with rare or cutaneous pediatric non-Hodgkin lymphoma (NHL).

           -  To determine the pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry.

           -  To establish a bank of these pathologically reviewed diseases and make specimens of blood and tissue available to qualified researchers.

           -  To determine sub-groups of these diseases that could be targeted for future biologic, pathologic, or therapeutic studies.

         OUTLINE: On study data will include presenting symptoms and signs, physical description of the tumor if it is on the skin, results of metastatic evaluation, stage (if available), blood count, markers, and the results of viral serologies. Any existing underlying conditions that could predispose to lymphoma will also be noted.

         Demographic and outcomes data will be stored and maintained by the COG Research Data Center. Demographic data will be linked to the specimen data in the BPC database.

         The approach of this study is prospective data collection, including central pathologic review, relevant biologic studies, submission of material to the Biopathology Center (BPC) and collection of diagnostic and outcome data. Participants will be registered with a standard COG registration form for documentation of age, gender, race, date of diagnosis, initial presentation, initial work-up, and stage according to the standard staging for the specific disease, initial diagnostic procedure, and institutional diagnosis. Tissue will be sent according to guidelines in Section 4.0. Follow-up data, including relapse or progression and vital status will be reported annually for 5 years.

         Patients will be followed annually for 5 years and data will be collected including vital status, evidence/absence of disease, type of treatment received, progression/relapse and whether the patient continues on study.

    NCT ID:

    NCT01000753

    IRB Number:

    09-000893

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                                             
             
             
           
  8. A Phase 1b Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Relapsed or Refractory Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Their Standard Therapy

    Rochester, Minn., Jacksonville, Fla. View Summary

    A Phase 1b Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Relapsed or Refractory Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Their Standard Therapy

    Location:

    Rochester, Minn., Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and the recommended phase two dose (RPTD) of ABT-199 when administered in subjects with relapsed /refactory multiple myeloma who are receiving bortezomib and dexamethasone as their standard therapy.

    NCT ID:

    NCT01794507

    IRB Number:

    12-006410

    Who can I contact for additional information about this study?

  9. Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors

    Rochester, Minn. View Summary

    Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The objective of this trial is to make an initial assessment for this new treatment regimen and to show it is equal or superior to the current standard practice. With this initial assessment be hope to gain information suggesting further study of this regimen or discontinuation of this regimen before exposing large numbers of patients to this new treatment option. We also will gain experience with this new regimen giving insights as to possible modifications in dosing and monitoring and selection of patients for future treatment in case of positive results. For this initial study we plan to enroll up to 24 patients.

    NCT ID:

    NCT00578266

    IRB Number:

    06-006216

    Who can I contact for additional information about this study?

    Rochester: Shakila Khan, MD 507-284-3442
                        


  10. Phase 1/2 Trial of MLN9708 in Combination With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma

    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    Phase 1/2 Trial of MLN9708 in Combination With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of cyclophosphamide that can be combined with MLN9708 (ixazomib) and dexamethasone in patient with previously untreated symptomatic multiple myeloma (MM). (Phase I) II. To determine the complete plus very good partial response rate (>= VGPR) of MLN9708, used in combination with cyclophosphamide and dexamethasone in patients with previously untreated symptomatic MM. (Phase II) SECONDARY OBJECTIVES: I. To determine the progression free survival and overall survival among patients with previously untreated symptomatic MM following treatment with MLN9708 in combination with cyclophosphamide and dexamethasone followed by MLN9708 maintenance till progression. II. To determine the toxicities associated with MLN9708 in combination with cyclophosphamide and dexamethasone in patients with previously untreated symptomatic MM. TERTIARY OBJECTIVES: I. To examine the pharmacokinetics of MLN9708 when used in combination with cyclophosphamide and dexamethasone. II. To assess the incidence of neurotoxicity using patient completed questionnaires. OUTLINE: This is a phase 1, dose-escalation study of cyclophosphamide followed by a phase II study. INDUCTION THERAPY: Patients receive ixazomib orally (PO) on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive ixazomib PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-6 months for 5 years.

    NCT ID:

    NCT01864018

    IRB Number:

    13-000414

    Who can I contact for additional information about this study?

    Rochester: Shaji K. Kumar 507-284-2511
                        


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