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

Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Phase 2

Recruiting

Conditions: Refractory Mantle Cell Lymphoma
Recurrent Mantle Cell Lymphoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Lenalidomide
Procedure: Lumbar Puncture
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Biological: Tafasitamab
Drug: Venetoclax

First Posted Date: 2023-06-20

Last Posted Date: 2024-11-18

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 100

Registration Number: NCT05910801

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study to Assess Adverse Events and Compare How Crushed, Ground, and Intact Oral Tablets Venetoclax Moves Through the Body of Healthy Female Adult Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Venetoclax

First Posted Date: 2023-06-18

Last Posted Date: 2023-12-01

Lead Sponsor: AbbVie

Target Recruit Count: 15

Registration Number: NCT05909553

Locations: 🇺🇸
Acpru /Id# 255783, Grayslake, Illinois, United States

Venetoclax Combined With Azactidine in the Treatment of ALAL

Phase 2

Recruiting

Conditions: Acute Leukemia of Ambiguous Lineage

Interventions: Drug: Venetoclax
Drug: azactidine

First Posted Date: 2023-06-13

Last Posted Date: 2024-07-23

Lead Sponsor: Sheng-Li Xue, MD

Target Recruit Count: 22

Registration Number: NCT05901974

Locations: 🇨🇳
The First Affliated Hospital of Soochow University, Suzhou, China

Efficacy and Safety of Venetoclax Combined With BEAM Pretreatment in Autologous Transplantation for DLBCL

Not Applicable

Not yet recruiting

Conditions: Diffuse Large B Cell Lymphoma

Interventions: Drug: Venetoclax
Drug: Carmustine
Drug: Cytarabine
Drug: Etoposide
Procedure: Hematopoietic Cell Transplantation
Drug: Melphalan

First Posted Date: 2023-05-18

Last Posted Date: 2023-05-18

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 52

Registration Number: NCT05863845

Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma Refractory

Interventions: Drug: Ibrutinib
Drug: Venetoclax
Drug: Navitoclax
Drug: Rituximab

First Posted Date: 2023-05-18

Last Posted Date: 2024-08-12

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 40

Registration Number: NCT05864742

Locations: 🇦🇺
Flinders Medical Centre, Bedford Park, South Australia, Australia
🇦🇺
Peter MacCallum Cancer Centre, Parkville, Victoria, Australia
🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma

Phase 1

Recruiting

Conditions: Blastoid Variant Mantle Cell Lymphoma
Mantle Cell Lymphoma
Pleomorphic Variant Mantle Cell Lymphoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Biological: Glofitamab
Drug: Lenalidomide
Biological: Obinutuzumab
Procedure: Positron Emission Tomography
Drug: Venetoclax

First Posted Date: 2023-05-16

Last Posted Date: 2024-11-06

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 50

Registration Number: NCT05861050

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

Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.

Phase 2

Recruiting

Conditions: Venetoclax
Myeloid Malignancy
Hypomethylating Agent

Interventions: Drug: Venetoclax
Drug: Azacitidine or decitabine

First Posted Date: 2023-05-03

Last Posted Date: 2024-08-09

Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 78

Registration Number: NCT05841771

Locations: 🇨🇳
Shanghai Jiao Tong University School of Medicine Affilated Shanghai General Hospital, Shanghai, Shanghai, China

A Phase Ib Trial of Azacitidine, Venetoclax and Allogeneic NK Cells for Acute Myeloid Leukemia (ADVENT-AML)

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Drug: Venetoclax
Drug: NK Cells

First Posted Date: 2023-04-28

Last Posted Date: 2024-12-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 32

Registration Number: NCT05834244

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

A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)

Phase 1

Recruiting

Conditions: AML, Adult Recurrent
MDS

Interventions: Drug: LYT-200
Drug: Venetoclax
Drug: Azacitidine
Drug: Decitabine

First Posted Date: 2023-04-25

Last Posted Date: 2024-01-11

Lead Sponsor: PureTech

Target Recruit Count: 90

Registration Number: NCT05829226

Locations: 🇺🇸
Mass. General Hospital-Harvard, Boston, Massachusetts, United States
🇺🇸
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
🇺🇸
Baptist Health South Florida-Miami Cancer Institute, Miami, Florida, United States

and more 6 locations

Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia

Phase 2

Recruiting

Conditions: Refractory/Relapse Acute Myeloid Leukemia

Interventions: Drug: Venetoclax

First Posted Date: 2023-04-11

Last Posted Date: 2023-04-11

Lead Sponsor: Hematology department of the 920th hospital

Target Recruit Count: 42

Registration Number: NCT05807347

Locations: 🇨🇳
Department of Hematology,920th Hospital of Joint Logistic Support Force of People's Liberation, Kunming, Yunnan, China

Drug Development Updates

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