Venetoclax

Generic Name: Venetoclax

Brand Names: Venclexta, Venclyxto

Drug Type: Small Molecule

Chemical Formula: C_₄₅H_₅₀ClN_₇O_₇S

CAS Number: 1257044-40-8

Unique Ingredient Identifier: N54AIC43PW

Background: Venetoclax is a BCL-2 inhibitor that was initially approved by the FDA in April 2016 . Proteins in the B cell CLL/lymphoma 2 (BCL-2) family are important regulators of the apoptotic (programmed cell death) process , . Venetoclax is used to treat chronic lymphocytic leukemia (CLL) and certain types of small lymphocytic lymphoma . CLL is the most prevalent leukemia diagnosed in Western countries . Venetoclax was developed through reverse engineering of the BCL-2 protein family inhibitor, navitoclax . Venetoclax is approximately 10 times more potent than navitoclax with regard to induction of apoptosis in CLL cells . A new indication was approved in 2018 for the treatment patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy . Previously, this drug was indicated only for patients with 17p gene deletion .

Indication: 本品与阿扎胞苷联合用于治疗因合并症不适合接受强诱导化疗，或者年龄75岁及以上的新诊断的成人急性髓系白血病患者。

Associated Conditions: Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Associated Therapies: -

Clinical Trials

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Phase 1

Recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Venetoclax
Drug: Lenalidomide
Drug: Rituximab

First Posted Date: 2018-05-14

Last Posted Date: 2024-07-05

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 28

Registration Number: NCT03523975

Locations: 🇺🇸
City of Hope Medical center, Duarte, California, United States
🇺🇸
University of Michigan, Ann Arbor, Michigan, United States
🇺🇸
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Venetoclax and Ibrutinib in Treating in Participants With Chronic Lymphocytic Leukemia and Ibrutinib Resistance Mutations

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Ibrutinib Resistance

Interventions: Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Drug: Venetoclax

First Posted Date: 2018-05-01

Last Posted Date: 2023-11-08

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Target Recruit Count: 28

Registration Number: NCT03513562

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Venetoclax, Lenalidomide and Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Phase 1

Conditions: Relapsed Non Hodgkin Lymphoma

Interventions: Drug: Venetoclax

First Posted Date: 2018-04-23

Last Posted Date: 2021-10-13

Lead Sponsor: Nordic Lymphoma Group

Target Recruit Count: 59

Registration Number: NCT03505944

Locations: 🇫🇮
Oulu University Hospital, Oulu, Finland
🇳🇴
Oslo University Hospital, Oslo, Norway
🇸🇪
Uppsla Academic Hospital, Uppsala, Sweden

and more 14 locations

Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

Phase 1

Active, not recruiting

Conditions: Recurrent Adult Lymphoblastic Lymphoma
Recurrent B Acute Lymphoblastic Leukemia
Recurrent B Lymphoblastic Lymphoma
Recurrent T Acute Lymphoblastic Leukemia
Recurrent T Lymphoblastic Lymphoma
Refractory B Acute Lymphoblastic Leukemia
Refractory B Lymphoblastic Lymphoma
Refractory T Acute Lymphoblastic Leukemia
Refractory T Lymphoblastic Lymphoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Lumbar Puncture
Procedure: Positron Emission Tomography
Drug: Venetoclax
Drug: Vincristine Liposomal
Drug: Vincristine Sulfate

First Posted Date: 2018-04-20

Last Posted Date: 2024-11-06

Lead Sponsor: ECOG-ACRIN Cancer Research Group

Target Recruit Count: 74

Registration Number: NCT03504644

Locations: 🇺🇸
OSF Saint Francis Medical Center, Peoria, Illinois, United States
🇺🇸
Illinois CancerCare-Peru, Peru, Illinois, United States
🇺🇸
Valley Radiation Oncology, Peru, Illinois, United States

and more 167 locations

A Study Of The Selective PKC-β Inhibitor MS- 553

Phase 1

Terminated

Conditions: Small Lymphocytic Lymphoma
Aggressive Lymphoma
Chronic Lymphocytic Leukemia

Interventions: Drug: MS-553
Drug: acalabrutinib
Drug: venetoclax
Drug: Rituximab
Drug: obinutuzumab

First Posted Date: 2018-04-10

Last Posted Date: 2024-07-18

Lead Sponsor: MingSight Pharmaceuticals, Inc

Target Recruit Count: 63

Registration Number: NCT03492125

Locations: 🇺🇸
University Of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Columbia University, Herbert Irving Comprehensive Cancer Center, New York, New York, United States
🇺🇸
MD Anderson Cancer Center, Department of Leukemia, Houston, Texas, United States

and more 2 locations

Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Phase 1

Active, not recruiting

Conditions: Blastic Plasmacytoid Dendritic Cell Neoplasm

Interventions: Drug: Venetoclax

First Posted Date: 2018-04-02

Last Posted Date: 2024-02-13

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 5

Registration Number: NCT03485547

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Cancer - Acute Myeloid Leukemia

Interventions: Drug: Venetoclax
Drug: Dinaciclib

First Posted Date: 2018-03-30

Last Posted Date: 2022-12-30

Lead Sponsor: AbbVie

Target Recruit Count: 48

Registration Number: NCT03484520

Locations: 🇺🇸
David Geffen School of Medicin /ID# 200015, Los Angeles, California, United States
🇺🇸
The Ohio State University /ID# 200668, Columbus, Ohio, United States
🇦🇺
Gold coast University Hospital /ID# 202759, SouthPort, Queensland, Australia

and more 10 locations

Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

Phase 1

Recruiting

Conditions: Hematopoietic and Lymphoid System Neoplasm
Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Recurrent Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Drug: Ivosidenib
Drug: Venetoclax

First Posted Date: 2018-03-20

Last Posted Date: 2024-07-26

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 96

Registration Number: NCT03471260

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 1 locations

A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Venetoclax
Drug: Rituximab
Drug: Rituximab/Hyaluronidase Human

First Posted Date: 2018-03-16

Last Posted Date: 2024-10-30

Lead Sponsor: Georgetown University

Target Recruit Count: 25

Registration Number: NCT03467867

Locations: 🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States
🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Phase 3

Active, not recruiting

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Interventions: Drug: Ibrutinib
Drug: Chlorambucil
Drug: Venetoclax
Drug: Obinutuzumab
Drug: Ibrutinib (as Subsequent Therapy)

First Posted Date: 2018-03-12

Last Posted Date: 2024-12-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 211

Registration Number: NCT03462719

Locations: 🇨🇦
Arthur J E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
🇺🇸
Norton Cancer Institute, Louisville, Kentucky, United States
🇺🇸
John Theurer Cancer Center, Hackensack, New Jersey, United States

and more 84 locations

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