Clinical Trials

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37 studies in Division of Hematology Research

  1. Treatment of Patients With Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
    Rochester, Minn. View Summary

    Treatment of Patients With Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: l. To determine if a maintenance regimen containing once weekly oral methotrexate at 40 mg/m^2/week will result in an improved disease-free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m^2/week in the average-risk (AR) subset of pediatric patients with standard-risk (SR) B-precursor acute lymphoblastic leukemia (ALL). II. To determine whether a reduced-pulses maintenance regimen with vincristine sulfate/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the AR subset of patients with SR B-precursor ALL. III. To confirm that patients in the low-risk (LR) subset of SR B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5-year DFS of at least 95% with either a P9904-based regimen that includes 6 courses of intermediate dose (1 g/m^2 over 24 hours) methotrexate without alkylating agents or anthracyclines (Arm LR-M), or an outpatient-based regimen identical to that of AR patients with reduced vincristine sulfate/dexamethasone pulses at 12-week intervals during maintenance (Arm LR-C). IV. To provide standardized treatment and enhanced supportive care to children with SR Down syndrome-ALL in order to improve outcomes and facilitate further study of this biologically and clinically unique patient subgroup. V. To improve understanding of the biology of localized B-LLy and DS B-LLy by obtaining biologic data, including FISH for recurrent cytogenetic lesions on paraffin specimen, and banking tissue for future research. VI. To describe the 5-year EFS and overall survival (OS) of patients with Murphy Stage I and II B-LLy receiving modified AR B-ALL therapy. SECONDARY OBJECTIVES: I. To assess the burden of AR-ALL therapy as measured by surveys of the child's quality of life, missed days of school/daycare/work by children and parents, family functioning, parental perception of the child's health vulnerability, physical functioning, and emotional distress overall at different time points during and at the end of therapy. II. To assess the burden of AR-ALL therapy as measured by surveys of the child's quality of life, missed days of school/daycare/work by children and parents, family functioning, parental perception of the child's health vulnerability, physical functioning, and emotional distress by comparing children randomized to every 4-week vs every 12-week dexamethasone/vincristine sulfate pulses during maintenance therapy. III. To characterize the onset, severity, and natural history of vincristine associated neuropathy by physical therapists (or occupational therapists) in children undergoing therapy for AR-ALL, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during Maintenance. IV. To characterize the onset, severity, and natural history of vincristine associated neuropathy by physical therapists (or occupational therapists) in children undergoing therapy for AR B-ALL, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during Maintenance. V. To explore the correlation of minimal marrow disease (MMD) at diagnosis and outcome for patients with B-LLy. OUTLINE: This is a multicenter study. All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate* on days 8 and 29. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 [> 25% lymphoblasts] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study. NOTE: *Patients with DS also receive oral leucovorin calcium every 12 hours on days 10-11 and 31-32. STANDARD-RISK WITH DOWN SYNDROME: Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; IT methotrexate on days 1, 8, and 15; and oral leucovorin calcium every 12 hours on days 3-4, 10-11, and 17-18. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on day 31; and oral leucovorin calcium every 12 hours on days 36-34. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone orally or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; oral thioguanine on days 29-42; cytarabine IV over 1-15 minutes or subcutaneously (SC) on days 29-32 and 33-39; IT methotrexate on days 1 and 29; and oral leucovorin calcium every 12 hours on days 3-4 and 31-32. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on days 1 and 31; and oral leucovorin calcium every 12 hours on days 3-4 and 33-34. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; oral dexamethasone BID on days 1-5; oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years (timed from the start of interim maintenance I therapy). AVERAGE-RISK: Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; and IT methotrexate on days 1, 8, and 15.Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed intensification therapy (8 weeks): Patients receive dexamethasone orally or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; oral thioguanine on days 29-42; cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients are randomized to 1 of 4 maintenance therapy treatment arms. Arm A: Patients receive vincristine sulfate IV on days 1, 29, and 57; oral dexamethasone BID on days 1-5, 29-33, and 57-61; oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1. Arm B: Patients receive vincristine sulfate IV on days 1, 29, and 57; oral dexamethasone BID on days 1-5, 29-33, and 57-61; higher-dose oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1. Arm C: Patients receive vincristine sulfate IV on day 1; oral dexamethasone BID on days 1-5; oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1. Arm D: Patients receive vincristine sulfate IV on day 1; oral dexamethasone BID on days 1-5; higher-dose oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1. In all arms, maintenance therapy courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy). LOW-RISK: Patients are randomized to 1 of 2 treatment arms. Arm I (LR-M): Consolidation therapy (19 weeks): Beginning one week after completion of induction therapy, patients receive vincristine sulfate IV on days 15, 22, 78, and 85; methotrexate IV over 24 hours and IT methotrexate on days 8, 29, 50, 71, 92, and 113; leucovorin calcium orally or IV on days 9-10, 30-31, 51-52, 72-73, 93-94, and 114-115; dexamethasone orally or IV BID on days 15-21 and 78-84; and oral mercaptopurine on days 1-133.Maintenance therapy: Patients receive vincristine sulfate IV on days 1 and 8; oral dexamethasone BID on days 1-7; oral methotrexate* on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, and 106; and oral mercaptopurine on days 1-112. Courses repeat every 16 weeks. Patients also receive IT methotrexate on days 1 and 85 (courses 1 and 4), day 57 (courses 2 and 5), or day 29 (courses 3 and 6). Patients then receive course 7 comprising vincristine sulfate IV on days 1 and 8; oral dexamethasone BID on days 1-7; oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64; and oral mercaptopurine on days 1-70. Treatment continues for 2 and ½ years (timed from the date of diagnosis).NOTE: *Patients do not receive oral methotrexate on the days that they receive IT methotrexate. Arm II (LR-C): Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; and IT methotrexate on days 1, 8, and 15. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone orally or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; oral thioguanine on days 29-42; cytarabine IV over 1-15 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29.Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; oral dexamethasone BID on days 1-5; oral methotrexate on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; oral mercaptopurine on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy). Blood samples may be collected periodically for research studies and patients may complete quality-of-life surveys periodically. After completion of study treatment, patients are followed up periodically for 10 years.

    NCT ID:

    NCT01190930

    IRB Number:

    10-005606

    Who can I contact for additional information about this study?

    Rochester: Vilmarie Rodriguez 507-538-7623
                        


  2. Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin s Lymphoma
    Rochester, Minn. View Summary

    Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin s Lymphoma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The treatment portion of this study consists of study drug administrations each week for four weeks in a row (a total of 4 treatment days). Patients will then return at intervals up to 12 weeks for blood samples and for evaluations to see if their disease responded and to monitor any adverse effects related to treatment. Some blood tests may then need to be repeated at least a few times and/or until any abnormal findings at earlier evaluations have resolved. Otherwise, patients will continue to be evaluated every 3 months for two years, then every 6 months up to 5 years or until the disease worsens. Participation in the study will end when NHL disease worsens.

    NCT ID:

    NCT01101581

    IRB Number:

    10-008298

    Who can I contact for additional information about this study?

    Rochester: Jennifer Jensen, RN
                        


  3. Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children s Oncology Group (COG) Study
    Rochester, Minn. View Summary

    Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children s Oncology Group (COG) Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: - To define the relationship between the status of donor NK-cell receptor and patient outcomes after killer immunoglobulin-like receptor-incompatible unrelated donor (URD) and umbilical cord blood (UCB) hematopoietic cell transplantation (HCT) in young patients with acute myeloid leukemia with monosomy 7, -5/5q-, high FLT3 internal tandem duplication allelic ratio (High-FLT3-ITD AR), or refractory or relapsed acute myelogenous leukemia. - To correlate the relationships between factors affecting NK receptor status and clinical events. - To assess NK-cell development after URD and UCB HCT in patients with poor prognosis AML. - To evaluate NK-cell reconstitution and receptor-acquisition pattern in these patients. OUTLINE: This is a multicenter study. - Preparative regimen: Patients receive 1 of the following regimens: - Hematopoietic stem cell transplantation (SCT): Patients receive busulfan IV every 6 hours on days -9 to -6, high-dose cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV once or twice daily over 4 hours on days -3 to -1, and methylprednisolone IV on days -3 to -1. - Umbilical cord blood (UCB) transplantation: Conditioning regimen, infusion procedures, and post-transplant immunoprophylaxis for patients with an UCB donor are according to institutional guidelines and standards. - Allogeneic hematopoietic stem cell transplantation (SCT) or umbilical cord blood (UCB) transplant: Patients undergo allogeneic SCT or UCB transplant on day 0. - Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine or tacrolimus IV or orally beginning on day -2 and continuing until day 50, followed by a taper until week 24. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Blood samples will be collected periodically from both patients and donors for studies of natural killer cells in support of the study objectives. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for 3 years.

    NCT ID:

    NCT00553202

    IRB Number:

    08-005561

    Who can I contact for additional information about this study?

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


  4. 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
                        


  5. 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?

  6. 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
                        

  7. 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
                        

  8. 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., Phoenix/Scottsdale, Ariz. 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., Phoenix/Scottsdale, Ariz.

    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?

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

  9. 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
                                             
             
             
           
  10. MC1082: A Phase I/II Trial of Pomalidomide (CC-4047), Bortezomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
    Rochester, Minn., Jacksonville, Fla., Phoenix/Scottsdale, Ariz. View Summary

    MC1082: A Phase I/II Trial of Pomalidomide (CC-4047), Bortezomib, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

    Location:

    Rochester, Minn., Jacksonville, Fla., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of bortezomib in combination with pomalidomide and dexamethasone. II. To evaluate the hematologic response rate (PR, VGPR, or CR) of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory myeloma. SECONDARY OBJECTIVES: I. Time to progression. II. To assess the toxicity of pomalidomide, bortezomib and dexamethasone in this patient population. OUTLINE : This is a phase I, dose-escalation study of bortezomib followed by a phase II study. Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8,15, 22; and oral dexamethasone on days 1, 8, 15, 22 . Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.

    NCT ID:

    NCT01212952

    IRB Number:

    10-001545

    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
                        
    Jacksonville: Mayo Clinic Clinical Trials Office 507-538-7623
                        
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