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16378 - A Phase 2 Study of Nivolumab and Brentuximab Vedotin Consolidation After Autologous Stem Cell Transplantation in Patients With High-Risk Classical Hodgkin Lymphoma
Rochester, Minn.
This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back or does not respond to treatment. Monoclonal antibodies, such as nivolumab and brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread.
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A Phase 1, Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients with Peripheral T-Cell Lymphoma (PTCL)
Rochester, Minn.
The purpose of this study is to evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL).
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A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies
Jacksonville, Fla.,
Rochester, Minn.
The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and INCB039110, a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with INCB039110 in subjects with relapsed/refractory B-cell malignancies.
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A Phase 1/2 Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies
Rochester, Minn.
The purpose of this study is to determine the maximum tolerated dose of this drug (MEDI-551) in subjects with advanced B-cell malignancies. Expansion to occur at maximum tolerated dose (MTD), or if not reached, at optimal biologic dose (OBD).
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A Phase 1/2, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma
Rochester, Minn.
The Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma. The Phase 2 portion of the study will investigate the efficacy and safety of TAS4464 in patients with Multiple Myeloma or Lymphoma
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A Phase 2 Randomized Open-label Study of MEDI-551 in Adults with Relapsed or Refractory DLBCL
Rochester, Minn.
The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.
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A Phase I and Feasibility Study of Everolimus (RAD001) Plus R-CHOP for New Untreated Diffuse Large B-Cell Lymphoma (DLBCL)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer cells in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. 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 or stopping them from dividing. Giving everolimus together with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and the best dose of everolimus when given together with rituximab and combination chemotherapy in treating patients with newly diagnosed untreated diffuse large B-cell lymphoma.
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A Phase II Study of the Histone Deacetylase (HDAC) Inhibitor LBH589 (Panobinostat) in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
Rochester, Minn.
Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well panobinostat works in treating patients with relapsed or refractory non-Hodgkin lymphoma.
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A Randomized Double-blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype
Rochester, Minn.
This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.
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A Randomized Phase II Trial of Myeloablative Versus Non-Myeloablative Consolidation Chemotherapy for Newly Diagnosed Primary CNS B-cell Lymphoma
Rochester, Minn.
RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma.
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BGB-3111-302 - 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)
Rochester, Minn.
This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111 vs ibrutinib in subjects with MYD88 Mutation Waldenström's Macroglobulinemia.
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BGB-3111-AU-003 - A Phase I, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects with B-Cell Lymphoid Malignancies
Rochester, Minn.
The purpose of this study is to evaluate the safety, tolerability, drug/body interactions, and treatment effects of a new drug known as BGB-3111 in patients who have B-cell lymphoid malignancies.
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BGB-3111-LTE1 - An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies (BGB-3111-LTE1)
Rochester, Minn.
The purpose of this study is to evaluate the long-term safety and effectiveness of zanubrutinib in participants with B-cell malignancies who were previously enrolled in an eligible BeiGene study.
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CA209647 A Phase 2, Open-label, Single-arm, Two-cohort Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Relapsed/Refractory Primary Testicular Lymphoma (PTL) (CheckMate 647)
Rochester, Minn.
The purpose of this study is to determine whether Nivolumab is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
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EA4151, A Randomized Phase III Trial of Consolidation With Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients With Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission
Jacksonville, Fla.,
Rochester, Minn.
This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.
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HH2853-G101, A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853, an EZH1/2 Inhibitor, in Patients With Relapsed/Refractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (how a drug moves within the body) and clinical activity of HH2853, an EZH1/2 Inhibitor, in patients with relapsed/refractory Non-Hodgkin's lymphomas or advanced solid tumors.
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Intergroup Randomized Phase 2 Four Arm Study In Patients ≥ 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab Bendamustine Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab Bendamustine Followed By Lenalidomide Rituximab Consolidation (RB → LR) or Arm D = Rituximab Bendamustine Bortezomib Followed By Lenalidomide Rituximab Consolidation (RBV → LR)
Rochester, Minn.
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma.
PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.
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JCAR017-BCM-003 A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM). (TRANSFORM)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.
The study is designed to determine if JCAR017 is superior to current standard of care (SOC) therapy for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL). JCAR017 is a CAR-T therapy directed against CD19 (a cell surface protein on NHL cancer cells), meaning that a patient's own T-cells are collected from their blood, genetically modified to attack their cancer cells, then re-infused into their body.
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KTE-C19-107: A Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine if axicabtagene ciloleucel is superior to standard of care (SOC) as measured by event-free survival (EFS), as determined by blinded central review.
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Phase 1 Dose Finding Study of Belinostat Plus Cyclophosphamide/Vincristine/Doxorubicin/Prednisone (CHOP) Regimen (BelCHOP) for Treatment of Patients With Peripheral T-cell Lymphoma(PTCL)
Rochester, Minn.
The primary objective of this study is to determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study.
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Phase 1 Study of Everolimus in Combination With Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma
Rochester, Minn.
This phase I trial studies the side effects and the best dose of everolimus when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has come back (relapsed) or is not responding to treatment (refractory). Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Brentuximab vedotin may interfere with the ability of cancer cells to grow and spread by binding to a protein on the surface of cancer cells and then releasing a cancer-killing substance to them. Giving everolimus together with brentuximab vedotin may be a better treatment for Hodgkin lymphoma.
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Phase I Clinical Trial for Evaluation of Nivolumab and Pomalidomide Combination for Relapsed/Refractory Primary Central Nervous System Lymphoma and Primary Vitreoretinal Lymphoma
Jacksonville, Fla.,
Rochester, Minn.
The purpose of this study is to evaluate the side effects and best dose of pomalidomide when given together with dexamethasone in treating patients with primary central nervous system lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone may kill more cancer cells.
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Phase I Trial of Pomalidomide for Patients with Relapsed/Refractory Primary CNS Lymphoma and Primary Vitreoretinal Lymphoma
Rochester, Minn.,
Jacksonville, Fla.
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.
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Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of P276-00 in Patients with Relapsed and/or Refractory Mantle Cell Lymphoma
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The purpose of this study is to determine whether P276-00 is safe and effective for the treatment of Mantle Cell Lymphoma that has returned or is not responding to at least one previous line of treatment.
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TAK-981-1501: Phase 1/2 Study of TAK-981 in Combination With Rituximab in Patients With Relapsed/Refractory CD20-positive Non-Hodgkin Lymphoma
Rochester, Minn.
The purpose of this study is to determine the safety and tolerability of TAK-981 in combination with rituximab in participants with r/r CD20+ NHL in Phase 1b, and to evaluate the effectiveness of TAK-981 in combination with rituximab in r/r CD20+ NHL in Phase 2.
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