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A PHASE I STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETIC AND PHARMACODYNAMIC PROPERTIES OF APG-2575 MONOTHERAPY OR COMBINATION THERAPY IN PATIENTS WITH HEMATOLOGIC MALIGNANCIES
Jacksonville, Fla.
The purpose of this study is to evaluate the safety and tolerability of APG-2575 as well as dose escalation and dose expansion stages.
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DTRM-555_001, Phase II Expansion Cohorts Studies of a Novel Triple Combination Therapy, DTRM-555, in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Non-Hodgkin’s Lymphomas
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the effectiveness of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkin's lymphoma.
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MC168E: Randomized Phase 2 Study Comparing Acalabrutinib to Acalabrutinib and Obinutuzumab in the Treatment of Patients With Early-Stage Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Who Are at High Risk of Disease Progression
Scottsdale/Phoenix, Ariz.,
Jacksonville, Fla.,
Rochester, Minn.
This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating participants with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Minimal Residual Disease in Chronic Lymphocytic Leukemia
Rochester, Minn.
The purpose of this study is to compare whether minimal residual disease (MRD) flow cytometric assay is not affected by different anticoagulants.
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MK-1026-003: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies
Rochester, Minn.
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 Phase 2/3, Open-label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Emapalumab in Adult Patients with Hemophagocytic Lymphohistiocytosis
Rochester, Minn.
The primary purpose of this study is to assess the effectiveness of emapalumab in adult patients with Hemophagocytic Lymphohistiocytosis (HLH), as measured by Overall Response Rate.
Secondary objectives are to assess the effectiveness of emapalumab as measured by overall survival, time to response, best response on treatment, duration of response; to evaluate the safety and tolerability of emapalumab; to determine the pharmacokinetic (PK) profile of emapalumab; and to determine the pharmacodynamic (PD) profile of emapalumab.
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A Phase IB Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Rochester, Minn.
The purpose of this study is to assess the safety, tolerability, pharmaokinetics, and preliminary effectiveness of mosunetuzumab in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
Closed for Enrollment
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A PHASE I STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETIC AND PHARMACODYNAMIC PROPERTIES OF APG-2575 MONOTHERAPY OR COMBINATION THERAPY IN PATIENTS WITH HEMATOLOGIC MALIGNANCIES
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety and tolerability of APG-2575 as well as dose escalation and dose expansion stages.
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A Phase II, Two-Cohort, Open-Label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of MOR00208 Combined With Idelalisib or Venetoclax in Patients With Relapsed or Refractory CLL/SLL Previously Treated With Bruton's Tyrosine Kinase (BTK) Inhibitor
Jacksonville, Fla.,
Rochester, Minn.
This is a two-cohort, multicenter, open-label study of MOR00208 combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy.
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A Prospective Observational Study to Assess Monoclonal B-cell Lymphocytosis in Individuals with Chronic Hepatitis C
Rochester, Minn.
The purpose of this study is to:
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To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with DAA, and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic
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To determine the correlation between the specific subtype of MBL (CD5- MBL, atypical CLL-phenotype MBL and CLL-phenotype MBL) relative to the HCV genotype
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To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy with DAA
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A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, can block cancer growth in difference 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 bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet know whether rituximab with bendamustine hydrochloride is more effective than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.
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Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia (“PRO-SID” study) (PRO-SID)
Rochester, Minn.
The purpose of this study is to demonstrate the benefit of Panzyga administration compared with placebo as primary infection prophylaxis in Chronic Lymphocytic Leukemia (CLL) patients with secondary immunodeficiency (SID) undergoing CLL antineoplastic therapy.
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Immunogenicity and Safety of Commercially Available Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients with Hematologic Malignancies and Associated Precursor Conditions
Rochester, Minn.
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.
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Immunogenicity of a Recombinant Varicella Zoster Vaccine (Shingrix) in Patients with Hematologic Malignancies
Rochester, Minn.
The purpose of this study is to compare the response of Shingrix vaccination among patients with untreated MBL and low-risk CLL to patients with untreated intermediate and high-risk CLL.
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MK-1026-001 A Phase 1/2 Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of MK-1026 in Selected Subjects with Relapsed or Refractory Hematologic Malignancies
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate MK-1026 in patients with selected hematologic malignancies.
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U2-VEN-207 - Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects With Chronic Lymphocytic Leukemia (CLL) (ULTRA-V)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to investigate the effectiveness and safety of ublituximab in combination with umbralisib and venetoclax compared to ublituximab and umbralisib in subjects with previously-treated chronic lymphocytic leukemia (CLL).
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