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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.,
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 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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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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Tafasitamab, Lenalidomide and Venetoclax Combination Therapy for Relapsed or Refractory Mantle Cell Lymphoma (V-MIND): A Phase II Study With Safety Lead-In (V-MIND)
Rochester, Minn.
The purpose of this study is to determine how well tafasitamab, lenalidomide and venetoclax work in treating patients with mantle cell lymphoma that has come back (after a period of improvement) (relapsed) or that has not responded to previous treatment (refractory).
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MC210806, Phase 2 study of MRD guided, fixed duration therapy for previously untreated chronic lymphocytic leukemia with LOXO-305 and venetoclax (MIRACLE) (MIRACLE)
Rochester, Minn.
The purpose of this study is to determine if a new drug combination, pirtobrutinib and venetoclax, will help Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) cancer, as well as learn more about the side effects of this drug combination.
Everyone in this study will receive pirtobrutinib and venetoclax. Venetoclax is U.S. Food and Drug Administration (FDA) approved for the treatment of CLL and SLL. Pirtobrutinib is currently being studied in patients with CLL but it is not FDA approved yet. This drug combination is still experimental and is not approved by the FDA. Discontinuation of pirtobrutinib and venetoclax based on minimal residual disease (MRD) results is also investigational. However, the FDA has allowed the use of this drug combination in this research study.
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 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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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)
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
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)
Scottsdale/Phoenix, Ariz.,
Rochester, Minn.
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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