Clinical Trials

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5 studies in Division of Hematology Research in Rochester, MN.

  1. 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
                        


  2. 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
                        

  3. 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?

  4. A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
    Rochester, Minn. View Summary

    A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of MLN9708 versus placebo when added to lenalidomide and dexamethasone (LenDex) in patients with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.

    NCT ID:

    NCT01850524

    IRB Number:

    13-002303

    Who can I contact for additional information about this study?

  5. A Phase III Randomized Trial for Patients With de Novo AML Using Bortezomib and Sorafenib (IND#114480; NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD
    Rochester, Minn. View Summary

    A Phase III Randomized Trial for Patients With de Novo AML Using Bortezomib and Sorafenib (IND#114480; NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To compare event-free survival (EFS) and overall survival (OS) of patients with de novo acute myeloid leukemia (AML) without high allelic ratio fms-like tyrosine kinase (FLT3)/internal tandem duplications (ITD)+ mutations who are randomized to standard therapy versus bortezomib/standard combination therapy. II. To determine the feasibility of combining bortezomib with standard chemotherapy in patients with de novo AML. III. To compare the OS and EFS of high-risk patients treated with intensive Induction II with historical controls from AAML03P1 and COG-AAML0531. IV. To determine the feasibility of administering sorafenib (sorafenib tosylate) with standard chemotherapy and in a one year maintenance phase in patients with de novo high allelic ratio FLT3/ITD+ AML. SECONDRY OBJECTIVES: I. To assess the anti-leukemic activity of sorafenib in patients with de novo high allelic ratio FLT3/ITD+ AML. II. To compare the percentage of patients converting from positive minimal residual disease (MRD) to negative MRD after Intensive Induction II with historical controls from AAML03P1 and AAML0531. III. To compare OS, disease-free survival (DFS), cumulative incidence of relapse, and treatment-related mortality from end of Intensification I between patients allocated to best allogenic donor stem cell transplant (SCT) and comparable patients on AAML0531 who did not receive allogenic donor SCT. IV. To compare OS, DFS, cumulative incidence of relapse, treatment-related mortality, and severe toxicity between patients allocated to matched family donor SCT on AAML1031 and AAML0531. V. To assess the health-related quality of life (HRQOL) of patients treated with chemotherapy and SCT for AML. VI. To evaluate bortezomib pharmacokinetics (PK) in patients receiving the combination regimen. VII. To obtain sorafenib and metabolite steady state pharmacokinetics and pharmacokinetic-pharmacodynamic data in subjects with FLT3/ITD receiving sorafenib. VIII. To compare the changes in shortening fraction/ejection fraction over time between patients treated with and without dexrazoxane. IX. To refine the use of minimal-residual disease (MRD) detection with 4-color flow cytometry. X. To evaluate the prognostic significance of molecular MRD and its contribution to risk identification with multidimensional flow cytometry (MDF)-based MRD in patients with translocations amenable to quantitative real time (RT)-polymerase chain reaction (PCR) (e.g., t(8;21), inv(16), t(9;11), Wilms tumor 1 [WT1] expression). XI. To determine the leukemic involvement of the hematopoietic early progenitor cell and its role in defining response to therapy. XII. To define the leukemic stem cell population in patients with AML. XIII. To determine the prevalence and prognostic significance of molecular abnormalities of WT1, runt-related transcription factor (RUNX)1, mixed-lineage leukemia (MLL)-partial tandem duplication (PTD), tet methylcytosine dioxygenase 2 (TET2), Cbl proto-oncogene, E3 ubiquitin protein ligase (c-CBL), v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT), and other novel AML-associated genes in pediatric AML. XIV. To correlate the expression of cluster of differentiation (CD74) antigen as well as proteasome beta 5-subunit (PSMB5) gene expression and mutation with response to bortezomib. XV. To evaluate the changes in protein expression and unfolded protein response (UPR) in patients with AML. XVI. To determine the expression level of wild-type FLT3, and correlate with outcome and in vitro sensitivity to FLT3 inhibition. XVII. To collect biology specimens at diagnosis, treatment time points, and relapse for future biology studies XVIII. To create a pediatric-specific algorithm to predict the occurrence of grade 2-4 acute graft-versus-host disease (GVHD) prior to its clinical manifestations using a combination of pre-transplant clinical variables and serum GVHD biomarker concentrations in the first weeks after SCT. OUTLINE: This is a dose-escalation study of sorafenib tosylate. Patients are randomized to 1 of 2 treatment arms or offered treatment on a third arm. INDUCTION I: ARM A: Patients receive cytarabine intrathecally (IT) on day 1 and ADE chemotherapy comprising cytarabine intravenously (IV) over 1-30 minutes on days 1-10; daunorubicin IV over 1-15 minutes on days 1, 3, and 5; and etoposide IV over 1-2 hours on days 1-5. ARM B: Patients receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients also receive bortezomib IV on days 1, 4, and 8. ARM C (high-risk [HR] FLT3/ITD+ disease): Patients receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A and sorafenib tosylate orally (PO) on days 11-28. INDUCTION II: Patients without HR FLT3/ITD+ disease begin Induction II administration on day 29. ARM A (low-risk [LR] patients): Patients receive cytarabine IT and ADE chemotherapy as in Induction I Arm A. ARM A (HR patients): Patients receive cytarabine IT on day 1 and MA chemotherapy comprising high-dose cytarabine IV over 1-3 hours on days 1-4, and mitoxantrone IV over 15-30 minutes on days 3-6. ARM B (LR patients): Patients receive cytarabine IT, ADE chemotherapy, and bortezomib as in Induction I Arm B. ARM B (HR patients): Patients receive cytarabine IT and MA chemotherapy as in Induction II, Arm A (HR patients) and bortezomib IV on days 1, 4, and 8. ARM C (patients with HR FLT3/ITD+ disease, cohorts 1 and 2): Patients receive cytarabine IT on day 1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and etoposide IV over 1-2 hours on days 1-5, and sorafenib tosylate PO on days 1-28. Patients who achieve complete remission (CR) proceed to Intensification I (beginning on day 29). Patients with refractory disease are off protocol therapy. INTENSIFICATION I: ARM A: Patients receive cytarabine IT on day 1 and AE chemotherapy comprising high-dose cytarabine IV over 1-3 hours, and etoposide IV over 1-2 hours on days 1-5. ARM B: Patients receive cytarabine IT and AE chemotherapy in Intensification II, Arm A, and bortezomib IV on days 1, 4, and 8. ARM C (cohorts 1 and 2): Patients receive cytarabine IT and AE chemotherapy in Intensification II, Arm A, and sorafenib tosylate PO on daily on days 1-28. Patients who achieve CR proceed to Intensification II or stem cell transplantation (SCT) beginning on day 29. Patients with refractory disease are off protocol therapy. INTENSIFICATION II: ARM A (LR): Patients receive cytarabine IT on day 1 and MA chemotherapy as in Induction II, Arm A (HR patients). ARM B (LR): Patients receive cytarabine IT on day 1, MA chemotherapy as in Induction II, Arm A (HR patients), and bortezomib IV on days 1, 4, and 8. ARMS A AND B (HR and no donor for SCT): Patients receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9 and asparaginase intramuscularly (IM) on days 2 and 9. ARM C (HR cohorts 1 and 2): Patients receive cytarabine IT on day 1, MA chemotherapy as in Induction II, Arm A (HR patients), and sorafenib tosylate PO on days 1-28. STEM CELL TRANPLANTATION (SCT) (HR patients with matched family [MFD] or unrelated donor): CONDITIONING REGIMEN: Patients receive fludarabine IV over 30 minutes once daily on days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of busulfan. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO beginning on day -2 and continuing until day 98 (matched sibling donor) or day 180 (with taper) (other related/unrelated donors or cord blood) and methotrexate IV on days 1, 3, and 6 (matched sibling/cord blood donors) or days 1, 3, 6, and 11 (other related/unrelated donors). Patients with unrelated donors also receive antithymocyte globulin IV over 6-8 hours on days -3 to -1. MAINTENANCE: Patients in Arm C receive sorafenib tosylate PO starting on day 40-80 after completion of intensification II or SCT for one year. After completion of study therapy, patients are followed up monthly for 6 months, every 2 months for 6 months, every 3 months for 1 year, every 6 months for 1 year, and then yearly for up to 8 years.

    NCT ID:

    NCT01371981

    IRB Number:

    13-001879

    Who can I contact for additional information about this study?

    Rochester: Carola A. Arndt 507-538-7623