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

Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia

Phase 1

Terminated

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Azacitidine
Drug: Venetoclax
Drug: Pevonedistat

First Posted Date: 2019-11-21

Last Posted Date: 2024-06-04

Lead Sponsor: Medical College of Wisconsin

Target Recruit Count: 16

Registration Number: NCT04172844

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Acalabrutinib and Venetoclax with or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2

Recruiting

Conditions: Refractory Small Lymphocytic Lymphoma
Recurrent Small Lymphocytic Lymphoma
Recurrent Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia

Interventions: Drug: Acalabrutinib
Biological: Obinutuzumab
Drug: Venetoclax

First Posted Date: 2019-11-20

Last Posted Date: 2024-11-01

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 168

Registration Number: NCT04169737

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

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

Early Phase 1

Recruiting

Conditions: Lymphoma, B-Cell

Interventions: Drug: Rituximab Injection
Drug: Tafasitamab
Drug: Venetoclax
Drug: Rituximab SC
Drug: Gemcitabine
Drug: Cisplatin
Drug: Dexamethasone
Drug: Glofitamab

First Posted Date: 2019-11-13

Last Posted Date: 2024-06-12

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 18

Registration Number: NCT04161248

Locations: 🇨🇦
Kingston Health Sciences Centre, Kingston, Ontario, Canada
🇨🇦
University Health Network, Toronto, Ontario, Canada
🇨🇦
The Jewish General Hospital, Montreal, Quebec, Canada

and more 1 locations

A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Phase 3

Active, not recruiting

Conditions: Acute Myeloid Leukemia (AML)
Cancer

Interventions: Drug: Venetoclax
Drug: Azacitidine
Other: Best Supportive Care (BSC)

First Posted Date: 2019-11-13

Last Posted Date: 2024-12-19

Lead Sponsor: AbbVie

Target Recruit Count: 465

Registration Number: NCT04161885

Locations: 🇰🇷
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214892, Seoul, Seoul Teugbyeolsi, Korea, Republic of
🇪🇸
Hospital Clinic de Barcelona /ID# 215108, Barcelona, Spain
🇪🇸
Hospital Santa Creu i Sant Pau /ID# 240397, Barcelona, Spain

and more 162 locations

Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome

Phase 1

Recruiting

Conditions: Chronic Myelomonocytic Leukemia
Myelodysplastic Syndrome
Recurrent Myelodysplastic Syndrome
Therapy-Related Myelodysplastic Syndrome
Refractory Myelodysplastic Syndrome

Interventions: Drug: Azacitidine
Drug: Venetoclax

First Posted Date: 2019-11-12

Last Posted Date: 2024-12-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 116

Registration Number: NCT04160052

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

Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

Phase 1

Active, not recruiting

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: Cusatuzumab
Drug: Azacitidine
Drug: Venetoclax

First Posted Date: 2019-11-05

Last Posted Date: 2024-07-22

Lead Sponsor: OncoVerity, Inc.

Target Recruit Count: 61

Registration Number: NCT04150887

Locations: 🇵🇱
Szpital Uniwersytecki w Krakowie, Krakow, Poland
🇨🇭
Kantonsspital St.Gallen, St. Gallen, Switzerland
🇵🇱
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz, Poland

and more 20 locations

A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: MBG453
Drug: Venetoclax
Drug: Azacitidine

First Posted Date: 2019-11-04

Last Posted Date: 2024-08-20

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 90

Registration Number: NCT04150029

Locations: 🇺🇸
Duke Univ Medical Center ., Durham, North Carolina, United States
🇺🇸
Chattanooga Onc And Hem Assoc PC Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
🇺🇸
Huntsman Cancer Institute Univ of Utah ., Salt Lake City, Utah, United States

and more 10 locations