Closed for Enrollment

• A Phase 1b Dose Escalation Study To Assess The Safety Of AFM13 In Combination With Pembrolizumab In Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma (KEYNOTE- 206) Scottsdale/Phoenix, AZ Jacksonville, FL Rochester, MN

  The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.

• A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy And Safety Study Of NEOD001 Plus Standard Of Care Versus Placebo Plus Standard Of Care In Subjects With Light Chain (AL) Amyloidosis Scottsdale/Phoenix, AZ Jacksonville, FL Rochester, MN

  This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.

• A Phase 3, Randomized, Open-Label, Multicenter Study Comparing The Efficacy And Safety Of The Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 And Ibrutinib In Subjects With Waldenström's Macroglobulinemia (WM) Scottsdale/Phoenix, AZ Rochester, MN

  This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib in subjects with MYD88 Mutation Waldenström's Macroglobulinemia.

• A Phase I/II Clinical Trial Of The MTor Inhibitor RAD001 (Everolimus) In Combination With Lenalidomide (Revlimid) For Patients With Relapsed Or Refractory Lymphoid Malignancy Scottsdale/Phoenix, AZ Rochester, MN

  RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving everolimus together with lenalidomide may be an effective treatment for lymphoma.

  PURPOSE: This phase I/II trial is studying the side effects and best dose of giving everolimus and lenalidomide together and to see how well they work in treating patients with relapsed or refractory non-Hodgkin or Hodgkin lymphoma.

• A Phase I/II Study Of The Tolerability Of Lenalidomide And Low Dose Dexamethasone In Previously Treated Multiple Myeloma Patients With Impaired Renal Function Scottsdale/Phoenix, AZ Rochester, MN

  Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction.

  Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.

• A Phase Ib/II Study Evaluating The Safety And Efficacy Of Obinutuzumab In Combination With Idasanutlin In Patients With Relapsed Or Refractory Follicular Lymphoma And Obinutuzumab Or Rituximab In Combination With Idasanutlin In Patients With Relapsed Or Refractory Diffuse Large B-cell Lymphoma Scottsdale/Phoenix, AZ Rochester, MN

  This is a open-label, mutlicenter, non-randomized, study to evaluate the safety, efficacy, and pharmacokinetics of idasanutlin in combination with obinutuzumab in participants with R/R FL and rituximab in combination with idasanutlin in R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase 2 dose (RP2D) for idasanutlin in combination with obinutuzumab for FL and in combination with rituximab for DLBCL. The expansion phase is designed to further assess the safety and efficacy of obinutuzumab in combination with idasanutlin at the RP2D with the selected regimen in participants with R/R FL and of rituximab in combination with idasanutlin at the RP2D in participants with R/R DLBCL.

• A Phase II, Single Arm, Multicenter Trial To Determine The Efficacy And Safety Of CTL019 In Adult Patients With Relapsed Or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Scottsdale/Phoenix, AZ

  The purpose of this study is to determine the efficacy and safety of CTL019 in adult patients with relapsed or resistant diffuse large B-cell lymphoma.

• A Randomized, Open-label, Phase 3 Study In Subjects With Relapsed And Refractory Multiple Myeloma Receiving Carfilzomib In Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing Scottsdale/Phoenix, AZ

  The purpose of the study is to compare once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).

• A Single Arm, Open-Label Phase 2 Study Of Nivolumab (BMS-936558) In Subjects With Relapsed Or Refractory Follicular Lymphoma (FL) Scottsdale/Phoenix, AZ Rochester, MN

  The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.

• A Single-Arm, Open-Label, Phase 2 Study Of Nivolumab (BMS-936558) In Subjects With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure Of Autologous Stem Cell Transplant (ASCT) Or After Failure Of At Least Two Prior Multi-Agent Chemotherapy Regimens In Subjects Who Are Not Candidates For ASCT Scottsdale/Phoenix, AZ Rochester, MN

  The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT

• A Study Of The Natural History Of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease Scottsdale/Phoenix, AZ Rochester, MN

  The purpose of this study is to characterize the natural history of leukocyte chemotactic factor 2 amyloidotic (ALECT2) disease. In this observational study, participants with ALECT2 disease will be enrolled. Participants who have already reached end-stage renal disease (ESRD) will provide retrospective chart review data and biological specimens at baseline only. Other participants, in addition to retrospective chart review, will be followed prospectively.

• Defibrotide For Patients With Hepatic Veno-occlusive Disease (VOD): A Treatment IND Study (Under 21 CFR 312.34) Scottsdale/Phoenix, AZ Rochester, MN

  Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

• Phase I Trial Of Pomalidomide For Patients With Relapsed/Refractory Primary CNS Lymphoma And Primary Vitreoretinal Lymphoma Scottsdale/Phoenix, AZ Jacksonville, FL Rochester, MN

  This phase I clinical trial aims to elucidate the maximal tolerated dose and side effects of pomalidomide in patients with relapsed or refractory primary central nervous system lymphoma or newly diagnosed or relapsed or refractory vitreoretinal lymphoma (Intraocular lymphoma). The study will also determine the efficacy and survival related to pomalidomide therapy in a MTD expanded cohort.

  Rationale - Pomalidomide is a novel immunomodulatory agent, which has shown significant activity against CNS lymphoma in preclinical studies. Blood brain barrier is an obstacle in treatment of brain tumors such as CNS lymphoma. Pomalidomide was shown to have an excellent CNS penetration in a murine model: approximately 39% of systemically administered pomalidomide could penetrate the central nervous system. As such, pomalidomide is a promising immunomodulator to be tested in a clinical trial for CNS lymphoma. It works by killing the lymphoma cells directly as well as indirectly via activation of the immune response against lymphoma cells.

• Randomized Phase II Open Label Study Of Lenalidomide R-CHOP (R2CHOP) Vs. RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine And Prednisone) In Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma Scottsdale/Phoenix, AZ Rochester, MN

  This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.