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A Study to Evaluate LOXO-305 Vs. Approved BTK Inhibitor Approved Drugs to Treat Patients with Mantle Cell Lymphoma
Jacksonville, FL; Rochester, MN
The purpose of this study is to compare progression-free survival (PFS) of LOXO-305 as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL).
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A Study to Compare Three Chemotherapy Regimens for the Treatment of Patients with Newly- diagnosed Mantle Cell Lymphoma
Rochester, MN; Jacksonville, FL
The purpose of this study is to compare three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib, and to determine how well they work in treating patients with newly-diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, 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. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the ...
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A Study of TAK-981 in Combination with Rituximab in Participants with Relapsed/Refractory (r/r) CD20-positive (CD20+) Non-Hodgkin Lymphoma (NHL)
Rochester, MN
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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Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of MK-1026 (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and macroglobulinemia (WM).
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A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies (MorningSun)
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma [NHL]).
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A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study consists of two parts to explore BGB-16673 recommended dosing: a part 1 monotherapy dose finding and a part 2 (cohort expansion in two cohorts).
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Study to Evaluate CCS1477 in Haematological Malignancies
Scottsdale/Phoenix, AZ
The purpose of this study is primarily designed to evaluate the safety and tolerability of CCS1477 in patients with relapsed or refractory acute myeloid leukaemia (AML)/high-risk myelodysplastic syndrome (MDS), multiple myeloma (MM) and non-Hodgkin lymphoma (NHL; B or T-cell).
CCS1477 is a potent, selective and orally bioavailable inhibitor of the bromodomain of p300 and CBP, critical transcriptional co-activators of genes that drive cell proliferation and survival. The compound causes G1 cell cycle arrest and is anti-proliferative across a broad range of haematological cell models, representative of AML, MM and lymphomas. This is also accompanied by an increase in myeloid differentiation in ...
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Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma
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.
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Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies
Rochester, MN
The purpose of this study is to determine the safety and tolerability of and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib.
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Exploring the Role of B-cell Activating Factor Receptor (BAFFR)-based Chimeric Antigen Receptor T-cell (CAR T) in BAFFR-expressing B-cell Hematologic Malignancies and Autoimmune Rheumatologic Disorders
Jacksonville, FL
The purposes of this study are to explore the therapeutic efficacy of BAFFR-CAR T cells in BAFFR-expressing B-cell hematologic malignancies including large B-cell, mantle cell and follicular lymphoma, chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-cell ALL) using primary tumor and/or patient derived xenograft models, and to explore the therapeutic efficacy of BAFFR-CAR T cells in autoimmune rheumatologic diseases including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis using primary samples and/or patient derived xenograft models.
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Immunogenicity and Safety of Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients with Hematologic Malignancies and Associated Precursors
Rochester, MN
The primary objective of this study is to determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies.
Secondary objectives of this study are to assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies, analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination. compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA, and analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination.