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, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

Phase 1

Completed

Conditions: Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Philadelphia Chromosome Positive
Recurrent Acute Lymphoblastic Leukemia
t(9;22)
Refractory Acute Lymphoblastic Leukemia
Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Interventions: Drug: Dexamethasone
Drug: Ponatinib Hydrochloride
Biological: Rituximab
Drug: Venetoclax

First Posted Date: 2018-07-03

Last Posted Date: 2024-11-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 11

Registration Number: NCT03576547

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Venetoclax and Azacitidine for Non-Elderly Adult Patients with Acute Myeloid Leukemia

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Drug: Venetoclax

First Posted Date: 2018-06-28

Last Posted Date: 2024-12-04

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 36

Registration Number: NCT03573024

Locations: 🇺🇸
Universtiy of Colorado Hospital, Aurora, Colorado, United States

A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Venetoclax
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2018-06-26

Last Posted Date: 2021-06-30

Lead Sponsor: AbbVie

Target Recruit Count: 8

Registration Number: NCT03567616

Locations: 🇬🇧
Norfolk and Norwich Univ Hosp /ID# 202240, Norwich, Norfolk, United Kingdom
🇪🇸
Hospital Universitario Vall d'Hebron /ID# 200967, Barcelona, Spain
🇺🇸
Washington University-School of Medicine /ID# 201287, Saint Louis, Missouri, United States

and more 8 locations

Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL

Phase 2

Active, not recruiting

Conditions: Lymphoma, Mantle-Cell

Interventions: Drug: Venetoclax

First Posted Date: 2018-06-26

Last Posted Date: 2024-12-09

Lead Sponsor: Fondazione Italiana Linfomi - ETS

Target Recruit Count: 141

Registration Number: NCT03567876

Locations: 🇮🇹
Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Ematologia, Reggio Calabria, Italy
🇮🇹
IRCCS Istituto Tumori Giovanni Paolo II, UOC Ematologia, Bari, Italy
🇮🇹
ASST Spedali Civili, Ematologia, Brescia, Italy

and more 32 locations

A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies

Phase 1

Recruiting

Conditions: Hematologic Malignancies

Interventions: Drug: Venetoclax
Drug: ethinyl estradiol/levonorgestrel

First Posted Date: 2018-06-15

Last Posted Date: 2024-08-29

Lead Sponsor: AbbVie

Target Recruit Count: 12

Registration Number: NCT03557619

Locations: 🇺🇸
Duplicate_Henry Ford Health System /ID# 209090, Detroit, Michigan, United States
🇦🇺
Peter MacCallum Cancer Centre-East Melbourne /ID# 225247, East Melbourne, Victoria, Australia
🇺🇸
Gabrail Cancer Center Research /ID# 207039, Canton, Ohio, United States

and more 1 locations

Use of Venetoclax as Single Agent in Patients With Relapsed/Refractory BCL-2 Positive Peripheral T Cell Lymphoma

Phase 2

Terminated

Conditions: T-Cell Lymphoma Refractory
T-Cell Lymphoma Relapsed

Interventions: Drug: Venetoclax

First Posted Date: 2018-06-12

Last Posted Date: 2023-12-12

Lead Sponsor: Fondazione Italiana Linfomi - ETS

Target Recruit Count: 22

Registration Number: NCT03552692

Locations: 🇮🇹
Azienda Sanitaria Universitaria Integrata di Udine (A.S.U.I. Udine) - SOC Clinica Ematologica, Udine, Italy
🇮🇹
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A, Aviano, Italy
🇮🇹
ASST Spedali Civili di Brescia - Ematologia, Brescia, Italy

and more 10 locations

A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.

Phase 3

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Dexamethasone
Drug: Pomalidomide
Drug: Venetoclax

First Posted Date: 2018-05-29

Last Posted Date: 2024-07-19

Lead Sponsor: AbbVie

Target Recruit Count: 265

Registration Number: NCT03539744

Locations: 🇺🇸
University of Maryland Medical Center /ID# 217422, Baltimore, Maryland, United States
🇺🇸
UPMC Hillman Cancer Ctr /ID# 200063, Pittsburgh, Pennsylvania, United States
🇺🇸
Cleveland Clinic Main Campus /ID# 202247, Cleveland, Ohio, United States

and more 177 locations

Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS

Phase 1

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Richter Syndrome

Interventions: Drug: Duvelisib
Drug: Venetoclax

First Posted Date: 2018-05-23

Last Posted Date: 2024-07-31

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 67

Registration Number: NCT03534323

Locations: 🇺🇸
Northern Light Eastern Maine Medical Center, Brewer, Maine, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Boston Medical Center, Boston, Massachusetts, United States

and more 4 locations

Venetoclax and Romidepsin in Treating Patients With Recurrent or Refractory Mature T-Cell Lymphoma

Phase 2

Completed

Conditions: Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Anaplastic Large Cell Lymphoma
Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

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

First Posted Date: 2018-05-23

Last Posted Date: 2023-10-19

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 12

Registration Number: NCT03534180

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
City of Hope Medical Center, Duarte, California, United States

A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Lymphoma
Multiple Myeloma
Acute Myeloid Leukemia
Diffuse Large B-Cell Lymphoma

Interventions: Drug: Maplirpacept (PF-07901801)
Drug: Anti-CD20 Targeting agent
Drug: Azacitidine
Drug: Carfilzomib
Drug: Venetoclax
Drug: Dexamethasone
Drug: Isatuximab

First Posted Date: 2018-05-21

Last Posted Date: 2023-12-22

Lead Sponsor: Pfizer

Target Recruit Count: 177

Registration Number: NCT03530683

Locations: 🇺🇸
LAC+USC Medical Center, Los Angeles, California, United States
🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Northside Hospital, Atlanta, Georgia, United States

and more 58 locations

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