Clinical Trials

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37 studies in Division of Hematology Research

  1. Phase II Study of LCL161 Alone and in Combination With Cyclophosphamide in Patients With Relapsed or Refractory Multiple Myeloma.
    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    Phase II Study of LCL161 Alone and in Combination With Cyclophosphamide in Patients With Relapsed or Refractory Multiple Myeloma.

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To evaluate the confirmed overall response rate (>= partial response [PR]) to LCL161, used as a single agent, in patients with relapsed multiple myeloma (MM). SECONDARY OBJECTIVES: I. To estimate the confirmed overall response rate to LCL161 in combination with cyclophosphamide, when cyclophosphamide is added to LCL161 for lack of response or progression. II. To estimate the overall survival and event-free survival of patients treated with LCL161 in combination with cyclophosphamide, when cyclophosphamide is added to LCL161 for lack of response or progression. III. To evaluate the tolerability of LCL161 alone and in combination with cyclophosphamide in patients with relapsed MM. TERTIARY OBJECTIVES: I. To determine degradation of cellular inhibitor of apoptosis protein-1 (cIAP1) in peripheral blood mononuclear cells (PBMC), changes in serum cytokines, and changes in immune cell subsets by flow cytometry. II. To correlate the effect of LCL161 with the presence of activating mutations of the nuclear factor kappa beta (NFKB) pathway. III. To evaluate the pharmacokinetics (PK) of LCL161 alone, and LCL161 in combination with cyclophosphamide. OUTLINE: Patients receive LCL161 orally (PO) once daily (QD) on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 also receive cyclophosphamide PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 1 year.

    NCT ID:

    NCT01955434

    IRB Number:

    12-010302

    Who can I contact for additional information about this study?

  2. 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
                        


  3. 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 for 1 year.

    NCT ID:

    NCT01864018

    IRB Number:

    13-000414

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Referral Office 507-538-7623
                        
    Scottsdale: Anne Allen 480-301-8756
                        

  4. A Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Intermediate-1, Myelodysplastic Syndrome Patients Based on the International Prognostic Scoring System
    Rochester, Minn. View Summary

    A Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Intermediate-1, Myelodysplastic Syndrome Patients Based on the International Prognostic Scoring System

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This will be a Phase II, single-arm, multicenter study (approximately 15 centers). Up to 40 transfusion-dependent patients with Low- or Int-1 risk MDS by IPSS will be enrolled and treated with 560 mg oral rigosertib BID taken intermittently (2 weeks on/1 week off regimen). Cycles will be 3 weeks in length. Enrollment will proceed as follows: In the first cohort, 6 patients will be enrolled initially. If no more than 1 drug-related Grade 3 toxicity (based on NCI CTCAE) is observed during the first 21-day cycle in the first 6 enrolled patients, 4 additional patients will be enrolled to complete the first cohort. Up to 3 more successive cohorts of 10 patients each will be enrolled, provided there are at least 1 response in the first cohort (10 patients), 4 responses total in the first and second cohorts (20 patients), and 6 responses total in the first, second and third cohorts (30 patients). The study will be stopped if any one of these responses is not met.

    NCT ID:

    NCT01904682

    IRB Number:

    13-009041

    Who can I contact for additional information about this study?

  5. Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
    Rochester, Minn. View Summary

    Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES:

           -  Establish a mechanism to bank specimens of tumor cells and host germline DNA from patients with acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma at first and subsequent relapse.

           -  Make these specimens available to qualified researchers to study the biology of ALL.

         OUTLINE: This is a multicenter study.

         Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment.

         Patients are followed periodically for up to 10 years.

         PROJECTED ACCRUAL: Not specified.

    NCT ID:

    NCT00897325

    IRB Number:

    07-007836

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                                             
             
             
           
  6. A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma
    Jacksonville, Fla. View Summary

    A Phase I/IIa Multi-dose Escalation Study of BT062 in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma

    Location:

    Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    BT062 is an antibody-drug conjugate designed to bind and destroy Myeloma cells. The study drug is being given in multiple doses with standard Multiple Myeloma treatments, lenalidomide and dexamethasone, to test how well the treatments are tolerated and work together. This study is a dose escalation study with the purpose to find out the highest dose of BT062 that a subject can tolerate in combination with lenalidomide and dexamethasone.

    NCT ID:

    NCT01638936

    IRB Number:

    12-002591

    Who can I contact for additional information about this study?

  7. A Phase I Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma
    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    A Phase I Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    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 recommended phase 2 dose (RPTD) of ABT-199 when administered in subjects with relapsed or refractory multiple myeloma.

    NCT ID:

    NCT01794520

    IRB Number:

    12-005388

    Who can I contact for additional information about this study?

  8. Phase 2 Trial of LDE225 and Lenalidomide Maintenance Post Autologous Stem Cell Transplant for Multiple Myeloma
    Rochester, Minn. View Summary

    Phase 2 Trial of LDE225 and Lenalidomide Maintenance Post Autologous Stem Cell Transplant for Multiple Myeloma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This phase II trial studies how well erismodegib and lenalidomide after stem cell transplant works in treating patients with multiple myeloma. Erismodegib and lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and may delay the recurrence of myeloma after a stem cell transplant.

    NCT ID:

    NCT02086552

    IRB Number:

    13-002492

    Who can I contact for additional information about this study?

  9. A Phase I Clinical Study of CWP232291 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome Having Failed Hypomethylating Treatment, and High-Risk Myelofibrosis
    Rochester, Minn. View Summary

    A Phase I Clinical Study of CWP232291 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome Having Failed Hypomethylating Treatment, and High-Risk Myelofibrosis

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The small molecule, CWP232291, by binding Sam68 promotes apoptosis in selective cancer cells through 1)induction of the TNF-α apoptotic pathway, 2)alternative splicing, tipping the balance towards pro-apoptotic as opposed to anti-apoptotic isoforms, and 3)inhibition of the anti-apoptotic Wnt driven gene, survivin

    NCT ID:

    NCT01398462

    IRB Number:

    11-008502

    Who can I contact for additional information about this study?

  10. A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma
    Rochester, Minn. View Summary

    A Multi-Center, Open-Label, Dose Escalation, Phase 1 Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The primary purpose of this dose escalation study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when administered orally once daily to adult patients with Multiple Myeloma (MM).

    NCT ID:

    NCT01456689

    IRB Number:

    11-007884

    Who can I contact for additional information about this study?

    Rochester: Susan Wescott
                        


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