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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study With An Open-label Period And Long-term Extension To Assess The Efficacy And Safety Of Rilzabrutinib In Participants With Warm Autoimmune Hemolytic Anemia (wAIHA) (LUMINA 3)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female participants ≥ 18 years of age with a confirmed diagnosis of primary wAIHA.
Following a 4-week screening period, eligible participants will be randomized in a 2:1 ratio to receive rilzabrutinib or placebo in primary analysis period (PAP) for a duration of up to 24 weeks. All participants who completed PAP will then continue in open-label period (OLP) to receive rilzabrutinib for a duration of 28 weeks. Upon the completion of OLP, only participants who demonstrate Hb increase during the last 8 weeks of OLP per specified criteria in the protocol will be eligible to continue in long-term extension (LTE) of the study. The duration of the LTE period will be from the first-participant-in (FPI)-LTE until the last participant completes 52 weeks in LTE. The safety follow-up period of this study following treatment completion or discontinuation will be 2 weeks.
Closed for Enrollment
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A Phase 1b, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Subjects With Chronic, Stable Warm Autoimmune Hemolytic Anemia (WAIHA)
Rochester, Minn.
This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia (WAIHA) disease activity markers of intravenous (IV) SYNT001.
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A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Intravenous ANX005 in Subjects With Warm Autoimmune Hemolytic Anemia (wAIHA) (ANX005 - wAIHA)
Rochester, Minn.
The purpose of this study is to evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
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A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) With Dexamethasone for Multiple Myeloma Patients With Relapsed or Refractory Disease
Jacksonville, Fla.,
Rochester, Minn.
This randomized phase II trial compares how well two different doses of carfilzomib work when given with dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or has not responded to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, 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. Giving carfilzomib together with dexamethasone may kill more cancer cells. It is not yet known whether a higher or lower dose of carfilzomib works better when given with dexamethasone.
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A Phase III Double-Blind, Randomized, Parallel Group, Multicenter Placebo-Controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients with Acquired Thrombotic Thrombocytopenic Purpura (HERCULES)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness and safety of caplacizumab treatment in more rapidly curtailing ongoing microvascular thrombosis when administered in addition to standard of care treatment in subjects with an acute episode of acquired thrombotic thrombocytopenic purpura.
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A Study to Evaluate the Complement Signature of Subjects
with Warm Autoimmune Hemolytic Anemia (ANX-WAIHA-01)
Rochester, Minn.
The purpose of this study is to measure and characterize markers of hemolysis (including but not limited to lactate dehydrogenase, indirect bilirubin, haptoglobin, and reticulocyte count), complement activation, and direct antiglobulin test (DAT), from subjects with Warm Autoimmune Hemolytic Anemia (wAIHA).
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Erdheim-Chester disease: patterns of care and clinical outcome
Rochester, Minn.
The purpose of this study is to collect data on patients with Erdheim-Chester Disease who have been seen at Mayo Clinic, Rochester in the last 40 years.
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Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry
Rochester, Minn.
This study is a collection of data to evaluate safety and characterize progression of Paroxysmal Nocturnal Hemoglobinuria (PNH).
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Prospective Follow-Up Study for Patients who Completed Study ALX0681-C301 (HERCULES) to Evaluate Long-Term Safety and Efficacy of Caplacizumab (Post-HERCULES)
Rochester, Minn.
The purpose of this study is to evaluate the long-term and repeated use safety and effectiveness of caplacizumab in patients who completed previous study ALX0681-C301.
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S1211, A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide With or Without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Jacksonville, Fla.,
Rochester, Minn.
RATIONALE: Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as elotuzumab, can block cancer growth 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 lenalidomide and dexamethasone also work in different ways to kill tumor cells or stop them from growing. Giving elotuzumab together with chemotherapy may be a better way to block cancer growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of elotuzumab and to see how well it works when given with lenalidomide, bortezomib, and dexamethasone in treating patients with multiple myeloma.
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