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

A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Phase 3

Active, not recruiting

Conditions: Acute Myeloid Leukemia (AML)

Interventions: Drug: Venetoclax
Drug: Azacitidine

First Posted Date: 2019-09-25

Last Posted Date: 2024-08-06

Lead Sponsor: AbbVie

Target Recruit Count: 112

Registration Number: NCT04102020

Locations: 🇺🇸
The John Theurer Cancer /ID# 215191, Hackensack, New Jersey, United States
🇺🇸
University of California, Los Angeles /ID# 219149, Los Angeles, California, United States
🇺🇸
Duplicate_Rush University Medical Center /ID# 218815, Chicago, Illinois, United States

and more 153 locations

Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia
Relapsed Cancer
Refractory Cancer
IDH2 Gene Mutation

Interventions: Drug: Enasidenib
Drug: Venetoclax

First Posted Date: 2019-09-17

Last Posted Date: 2024-01-24

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 27

Registration Number: NCT04092179

Locations: 🇨🇦
University of Alberta Hospital, Edmonton, Alberta, Canada
🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Drug: IMGN632
Drug: Venetoclax

First Posted Date: 2019-09-11

Last Posted Date: 2024-12-17

Lead Sponsor: AbbVie

Target Recruit Count: 218

Registration Number: NCT04086264

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 28 locations

A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: CPX-351
Drug: Venetoclax
Drug: Midostaurin
Drug: Enasidenib

First Posted Date: 2019-09-03

Last Posted Date: 2023-10-16

Lead Sponsor: Jazz Pharmaceuticals

Target Recruit Count: 57

Registration Number: NCT04075747

Locations: 🇺🇸
University of Kansas Cancer Center, Fairway, Kansas, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 7 locations

Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma

Phase 1

Terminated

Conditions: Primary CNS Lymphoma

Interventions: Drug: Venetoclax
Drug: Obinutuzumab

First Posted Date: 2019-08-29

Last Posted Date: 2022-01-19

Lead Sponsor: Klinikum Stuttgart

Target Recruit Count: 4

Registration Number: NCT04073147

Locations: 🇩🇪
Klinikum Stuttgart, Stuttgart, Baden-Württemberg, Germany

Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113

Phase 1

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Gemtuzumab Ozogamicin
Drug: Venetoclax

First Posted Date: 2019-08-28

Last Posted Date: 2023-12-13

Lead Sponsor: John Quigley

Target Recruit Count: 18

Registration Number: NCT04070768

Locations: 🇺🇸
University of Michigan Health System, Ann Arbor, Michigan, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

and more 1 locations

Study to Evaluate CCS1477 in Haematological Malignancies

Phase 1

Recruiting

Conditions: Non Hodgkin Lymphoma
Haematological Malignancy
Acute Myeloid Leukemia
Higher-risk Myelodysplastic Syndrome
Multiple Myeloma
Peripheral T Cell Lymphoma

Interventions: Drug: CCS1477
Drug: Pomalidomide
Drug: Azacitidine
Drug: Dexamethasone
Drug: Venetoclax

First Posted Date: 2019-08-28

Last Posted Date: 2024-03-15

Lead Sponsor: CellCentric Ltd.

Target Recruit Count: 250

Registration Number: NCT04068597

Locations: 🇺🇸
Mayo Clinic, Phoenix, Arizona, United States
🇬🇧
The Royal Marsden, Sutton, Surrey, United Kingdom
🇫🇷
Institute Gustave Roussy, Villejuif, France

and more 12 locations

AZA + Venetoclax as Maintenance Therapy in Patients With AML in Remission

Phase 2

Recruiting

Conditions: Hematologic and Lymphocytic Disorder
Therapy-Related Acute Myeloid Leukemia
FLT3 Gene Mutation
Acute Myeloid Leukemia
Minimal Residual Disease Persistence
Acute Myeloid Leukemia in Remission

Interventions: Drug: Azacitidine
Drug: Venetoclax

First Posted Date: 2019-08-20

Last Posted Date: 2024-12-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 50

Registration Number: NCT04062266

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

A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: CPX-351
Drug: Venetoclax

First Posted Date: 2019-07-30

Last Posted Date: 2022-11-09

Lead Sponsor: Jazz Pharmaceuticals

Target Recruit Count: 35

Registration Number: NCT04038437

Locations: 🇺🇸
Blood & Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
Dana Farber/ Brigham & Women's Cancer Center, Boston, Massachusetts, United States

and more 5 locations

A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors

Phase 1

Terminated

Conditions: Acute Lymphoblastic Leukemia (ALL)
Acute Myeloid Leukemia (AML)
Solid Tumors
Neuroblastoma

Interventions: Drug: Idasanutlin
Drug: Fludarabine
Drug: Venetoclax
Drug: Cyclophosphamide
Drug: Topotecan
Drug: Cytarabine
Drug: Intrathecal Chemotherapy

First Posted Date: 2019-07-23

Last Posted Date: 2024-12-20

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 38

Registration Number: NCT04029688

Locations: 🇺🇸
Arkansas Children's Hospital Research Institute, Little Rock, Arkansas, United States
🇺🇸
Lucile Packard Children's Hospital at Stanford University; Thoracic Oncology, Palo Alto, California, United States
🇺🇸
Arnold Palmer Hosp-Children, Orlando, Florida, United States

and more 11 locations

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