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Generated: March 23, 2019

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CLINICAL TRIALS PROFILE FOR VENCLEXTA

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Clinical Trials for Venclexta

Trial ID Title Status Sponsor Phase Summary
NCT02877550 Obinutuzumab in Combination With Venetoclax in Previously Untreated Follicular Lymphoma Patients Not yet recruiting Swiss Group for Clinical Cancer Research Phase 1 Follicular lymphoma (FL) is an indolent yet incurable lymphoma characterized by initial responses to standard therapies, invariably followed by shorter disease free intervals. Obinutuzumab, a novel type II, anti-CD20 monoclonal antibody has been approved in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia (CLL) and in combination with bendamustine followed by obinutuzumab alone for FL who did not respond to, or who progressed during or after treatment with rituximab or a rituximab-containing regimen, or in relapse after such treatment. Additionally, venetoclax, a small molecule Bcl-2 inhibitor, showed single agent activity in relapsed/refractory (R/R) CLL and other B-cell lymphomas, including R/R FL. Preclinical evidence suggests a synergism of the two drugs in vitro as well as in different lymphoma in vivo models. Based on single agent clinical activity and on the preclinical data of the combination of both drugs and aiming to develop a new chemotherapy-free combination regimen, this trial plans to evaluate the combination of obinutuzumab and venetoclax in previously untreated FL patients in need of systemic therapy. This phase I study will provide information on the safety and tolerability together with evidence of preliminary antitumor activity. Combination treatment consists of a 6 cycles of 28 days each. The combination therapy is followed by a 2 years maintenance with obinutuzumab. Dosing of obinutuzumab is as per Swissmedic approval in FL.Venetoclax will be administered in different dose levels according to the trial design.
NCT02950051 Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) W Recruiting Nordic CLL Study Group (NCLLSG) Phase 3 The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab, Obinutuzumab), which may induce extremely long lasting remissions.
NCT02950051 Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) W Recruiting Stichting Hemato-Oncologie voor Volwassenen Nederland Phase 3 The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab, Obinutuzumab), which may induce extremely long lasting remissions.
NCT02950051 Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) W Recruiting Swiss Group for Clinical Cancer Research Phase 3 The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab, Obinutuzumab), which may induce extremely long lasting remissions.
NCT02950051 Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) W Recruiting German CLL Study Group Phase 3 The aim of this study is to evaluate if standard chemoimmunotherapy (FCR, BR) in frontline treatment of physically fit CLL patients without del17p or TP 53 mutation can be replaced by combinations of targeted drugs (Venetoclax, Ibrutinib) with anti-CD20-antibodies (Rituximab, Obinutuzumab), which may induce extremely long lasting remissions.
NCT02992522 Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma Not yet recruiting National Cancer Institute (NCI) Phase 1 This phase I study studies the side effects and best dose of venetoclax and lenalidomide when given together with obinutuzumab in treating patients with B-cell non-Hodgkin lymphoma that has returned after a period of improvement or not responding to treatment. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, 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 obinutuzumab, venetoclax, and lenalidomide may work better in treating patients with B-cell non-Hodgkin lymphoma.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Venclexta

Condition Name

Condition Name for Venclexta
Intervention Trials
Chronic Lymphocytic Leukemia 8
Recurrent Plasma Cell Myeloma 3
Refractory Diffuse Large B-Cell Lymphoma 2
Refractory Plasma Cell Myeloma 2
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Condition MeSH

Condition MeSH for Venclexta
Intervention Trials
Leukemia 18
Leukemia, Lymphoid 13
Leukemia, Lymphocytic, Chronic, B-Cell 11
Lymphoma 7
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Clinical Trial Locations for Venclexta

Trials by Country

Trials by Country for Venclexta
Location Trials
United States 39
Switzerland 1
Denmark 1
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Trials by US State

Trials by US State for Venclexta
Location Trials
Texas 8
Massachusetts 6
Ohio 6
California 3
New York 3
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Clinical Trial Progress for Venclexta

Clinical Trial Phase

Clinical Trial Phase for Venclexta
Clinical Trial Phase Trials
Phase 3 4
Phase 2 10
Phase 1/Phase 2 9
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Clinical Trial Status

Clinical Trial Status for Venclexta
Clinical Trial Phase Trials
Not yet recruiting 17
Recruiting 13
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Clinical Trial Sponsors for Venclexta

Sponsor Name

Sponsor Name for Venclexta
Sponsor Trials
National Cancer Institute (NCI) 16
M.D. Anderson Cancer Center 6
Dana-Farber Cancer Institute 5
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Sponsor Type

Sponsor Type for Venclexta
Sponsor Trials
Other 31
NIH 16
Industry 9
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