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A Master Protocol To Evaluate The Long-Term Safety Of Pirtobrutinib
Rochester, Minn.
The purpose of this study is to evaluate the long-term safety of pirtobrutinib.
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A Modular Phase 2, Single-arm, Multicenter, Open-label Study To Evaluate The Efficacy And Safety Of AZD0486 In Participants With Relapsed Or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B) (SOUNDTRACK-B)
Rochester, Minn.
This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of AZD0486 monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for DLBCL.
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A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies
Rochester, Minn.,
Jacksonville, Fla.
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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A Phase 1b/2, Open-Label, Master Protocol Study Of BTK-Degrader BGB-16673 In Combination With Other Agents In Patients With Relapsed Or Refractory B-Cell Malignancies
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study will initially include two substudies, and more substudies may be added as they become available.
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A Phase 3 Randomized Double-Blind Multicenter Study Of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib In Patients With Relapsed/Refractory Mantle Cell Lymphoma
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
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Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Brexucabtagene
Autoleucel
Rochester, Minn.,
Jacksonville, Fla.
The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.
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GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma
Rochester, Minn.
Primary Objectives:
To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.
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Pilot Study of Glofitamab and Lenalidomide in Patients With Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With a BTK Inhibitor
Rochester, Minn.
The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma
Contact Us for the Latest Status
Closed for Enrollment
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A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) (LOXO-BTK-18001)
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate oral LOXO-305 in patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL) who have failed or are intolerant to standard of care.
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A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies
Scottsdale/Phoenix, Ariz.
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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A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321) (BRUIN-MCL-321)
Rochester, Minn.,
Jacksonville, Fla.
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 Phase II Study of Modified VR-CAP and Acalabrutinib as First Line Therapy for Transplant-Eligible Patients With Mantle Cell Lymphoma (ACCRU-LY-1804)
Rochester, Minn.
The purpose of this study is to investigate how well modified VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisone, and cytarabine hydrochloride) and acalabrutinib as first line therapy work in treating transplant-eligible patients with mantle cell lymphoma.
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ICP-CL-00107: A Phase I/II, Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The main purpose of this study is to assess the maximal dose of ICP-022 that can be safely administered.
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LOXO-BTK-20022, A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322) (BRUIN CLL-322)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to compare the effectiveness and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
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MC1485, A Phase II Study of Anti-PD-1 Antibody (MK-3475) in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Other Low Grade B Cell Non-Hodgkin Lymphoma (NHL)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
This phase II trial studies how well pembrolizumab alone or with idelalisib or ibrutinib works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas that have returned after a period of improvement or have not responded to treatment. Monoclonal antibodies can block cancer growth in different ways. Pembrolizumab may block cancer growth by blocking a cell that protects the cancer from the immune system and allowing the immune system to attack the cancer. Idelalisib and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab alone or with idelalisib or ibrutinib may be an effective treatment in patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas.
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MC1986 Phase I/Ib Study of Parsaclisib (INCB050465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (Par-CHOP) Immunochemotherapy for Patients with Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma
Rochester, Minn.,
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The primary purpose of this study in the dose-finding phase is to establish the maximum tolerated dose (MTD) of parsaclisib in combination with R-CHOP in newly-diagnosed DLBCL.
The primary purpose of the study in the dose-expansion phase is to assess the compete metabolic response rate by PEWT (PETW CR) of combining parsaclisib and R-CHOP in patients with newly-diagnosed DLBCL.
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MC210806 Phase 2 Study Of MRD Guided, FIxed DuRation TherApy For Previously Untreated Chronic Lymphocytic LeukEmia With Pirtobrutinib And Venetoclax (MIRACLE) (MIRACLE)
Rochester, Minn.
This phase II trial studies how well pirtobrutinib and venetoclax work in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. This study also seeks to adopt a blood test which shows a small number of cancer cells in the body after cancer treatment called minimal residual disease as a guide to determine length of treatment. Drugs used in chemotherapy, such as pirtobrutinib and venetoclax, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Identifying minimal residual disease results after combination chemotherapy may help guide future treatment decisions for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
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