Venclexta

Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia + 2 more
Treatment
4 FDA approvals
20 Active Studies for Venclexta

What is Venclexta

VenetoclaxThe Generic name of this drug
Treatment SummaryVenetoclax is a medication used to treat chronic lymphocytic leukemia (CLL) and certain types of small lymphocytic lymphoma. The drug works by blocking the BCL-2 proteins that prevent cells from dying naturally. It was first approved by the FDA in 2016 and was recently approved for use in patients who have had prior treatments. Venetoclax is more powerful than its predecessor, navitoclax, and is used to induce apoptosis (programmed cell death) in CLL cells.
Venclextais the brand name
image of different drug pills on a surface
Venclexta Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Venclexta
Venetoclax
2016
4

Approved as Treatment by the FDA

Venetoclax, otherwise known as Venclexta, is approved by the FDA for 4 uses such as Acute Myeloid Leukemia (AML) and Comorbidities .
Acute Myeloid Leukemia (AML)
Used to treat Acute Myeloid Leukemia (AML) in combination with Cytarabine
Comorbidities
Used to treat Comorbidities in combination with Cytarabine
Acute Myeloid Leukemia
Used to treat Acute Myeloid Leukemia (AML) in combination with Cytarabine
Newly Diagnosed
Used to treat Newly Diagnosed in combination with Cytarabine

Effectiveness

How Venclexta Affects PatientsVenetoclax is a drug used to treat chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) that works by causing the death of cancer cells. It has been found to be safe and effective in producing positive responses in patients with CLL or SLL, even those with a poor prognosis. It is not expected to have any major effects on the heart. Studies have shown that venetoclax has a success rate of around 80% in treating various types of blood cancers.
How Venclexta works in the bodyVenetoclax works to restore the process of cell death (apoptosis) in cancerous cells. It does this by directly attaching to BCL-2 proteins, which helps to replace the proteins that are responsible for keeping the cancer alive. This leads to the cancer cells being broken down and destroyed by enzymes, without causing too much damage to healthy cells. Venetoclax has been proven to be effective in treating some types of cancer, as well as reducing the side effects of other cancer treatments.

When to interrupt dosage

The measure of Venclexta is reliant upon the identified sickness. The amount of dosage fluctuates as per the strategy of delivery (e.g. Oral or Tablet) featured in the table beneath.
Condition
Dosage
Administration
Comorbidities
10.0 mg, , 50.0 mg, 100.0 mg, 260.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral
Small Lymphocytic Lymphoma
10.0 mg, , 50.0 mg, 100.0 mg, 260.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral
Chronic Lymphocytic Leukemia
10.0 mg, , 50.0 mg, 100.0 mg, 260.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral
Acute Myeloid Leukemia
10.0 mg, , 50.0 mg, 100.0 mg, 260.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral
Newly Diagnosed
10.0 mg, , 50.0 mg, 100.0 mg, 260.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet - Oral, Tablet, Kit; Tablet, Kit; Tablet - Oral

Warnings

Venclexta Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
There are 20 known major drug interactions with Venclexta.
Common Venclexta Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The serum concentration of Abemaciclib can be increased when it is combined with Venetoclax.
Acalabrutinib
Major
The metabolism of Acalabrutinib can be decreased when combined with Venetoclax.
Alectinib
Major
The metabolism of Alectinib can be decreased when combined with Venetoclax.
Aminophylline
Major
The metabolism of Aminophylline can be decreased when combined with Venetoclax.
Astemizole
Major
The metabolism of Astemizole can be decreased when combined with Venetoclax.
Venclexta Toxicity & Overdose RiskVenetoclax has been found to have an oral toxicity in mice of over 2001mg/kg. Taking Venetoclax while pregnant can be harmful to the baby. Men taking this drug may experience decreased fertility. There have not been any studies done yet to assess if Venetoclax can cause cancer. Tests for mutagenicity, chromosomal aberrations, and clastogenicity have all been negative.
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Venclexta Novel Uses: Which Conditions Have a Clinical Trial Featuring Venclexta?

243 active studies are presently examining the potential of Venclexta in providing therapeutic benefits for Small Lymphocytic Lymphoma.
Condition
Clinical Trials
Trial Phases
Comorbidities
2 Actively Recruiting
Phase 2, Not Applicable
Newly Diagnosed
3 Actively Recruiting
Phase 3, Phase 1
Small Lymphocytic Lymphoma
14 Actively Recruiting
Phase 2, Phase 1, Phase 3, Phase 4
Acute Myeloid Leukemia
266 Actively Recruiting
Phase 2, Phase 3, Phase 1, Phase 4, Not Applicable, Early Phase 1
Chronic Lymphocytic Leukemia
142 Actively Recruiting
Phase 1, Phase 2, Not Applicable, Phase 3, Early Phase 1, Phase 4

Venclexta Reviews: What are patients saying about Venclexta?

5Patient Review
5/10/2018
Venclexta for Chronic Lymphocytic Leukemia with 17p Deletion
I can only tolerate 50 mg of this drug, but it is very effective. Higher doses give me flu like symptoms.
5Patient Review
9/27/2017
Venclexta for Chronic Lymphocytic Leukemia with 17p Deletion
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Patient Q&A Section about venclexta

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Clinical Trials for Venclexta

Image of OHSU Knight Cancer Institute in Portland, United States.

Fludarabine + Cytarabine + Idarubicin + Venetoclax for Acute Myeloid Leukemia

18 - 65
All Sexes
Portland, OR
This phase II trial compares induction and consolidation therapy with fludarabine, cytarabine, idarubicin, and venetoclax to cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of acute myeloid leukemia (AML). Patients with AML often receive induction and consolidation therapy. Induction therapy is given first to get the patient's AML under control (remission). Consolidation therapy is given after the cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. Chemotherapy drugs, such as fludarabine, cytarabine, idarubicin, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving fludarabine, cytarabine, idarubicin, and venetoclax for induction and consolidation therapy may be more effective in treating AML.
Phase 2
Waitlist Available
OHSU Knight Cancer InstituteCurtis A Lachowiez
Image of Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center in Cleveland, United States.

Rituximab + Tafasitamab + NK Cells for Non-Hodgkin's Lymphoma

18+
All Sexes
Cleveland, OH
This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. NK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death). Participants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.
Phase 1
Waitlist Available
Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center (+1 Sites)Paolo Caimi, MDIncyte Corporation
Image of City of Hope Medical Center in Duarte, United States.

Venetoclax + Obinutuzumab + Epcoritamab for Chronic Lymphocytic Leukemia

18+
All Sexes
Duarte, CA
This phase II trial tests the effect of venetoclax and obinutuzumab followed by epcoritamab in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that have not previously received treatment. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Epcoritamab, a bispecific monoclonal antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. The combination of venetoclax and obinutuzumab is a standard treatment for CLL/SLL and has been found to be safe and effective. Adding epcoritamab to standard treatment with venetoclax and obinutuzumab may lead to deeper and longer-lasting responses in patients with untreated CLL/SLL.
Phase 2
Waitlist Available
City of Hope Medical Center (+6 Sites)Alexey V Danilov
Have you considered Venclexta clinical trials? We made a collection of clinical trials featuring Venclexta, we think they might fit your search criteria.Go to Trials
Image of Brigham and Women's Hospital in Boston, United States.

Tagraxofusp + Venetoclax + Azacitidine for Acute Myeloid Leukemia

18+
All Sexes
Boston, MA
The purpose of this research study is to test the safety and efficacy of a new drug combination with three agents, azacitidine, venetoclax and tagraxofusp. Leftover (residual) leukemia disease that is not visible by eye can be increase the chance of disease recurrence. This research study is to determine if the combination therapy can safely help to control residual Acute Myeloid Leukemia (AML) and to prevent disease recurrence. The names of the study drugs involved in this study are: * Tagraxofusp (a type of CD123-directed cytotoxin) * Azacitidine (a type of standard of care cytidine nucleoside analog) * Venetoclax (a type of standard of care BCL-2 inhibitor)
Phase 1 & 2
Recruiting
Brigham and Women's Hospital (+1 Sites)Jacqueline Garcia, MDStemline Therapeutics, Inc.
Have you considered Venclexta clinical trials? We made a collection of clinical trials featuring Venclexta, we think they might fit your search criteria.Go to Trials
Image of Fred Hutch/University of Washington Cancer Consortium in Seattle, United States.

Treatment Intensity for Acute Myeloid Leukemia

18+
All Sexes
Seattle, WA
This clinical trial studies whether less fit adults with acute myeloid leukemia (AML) or myeloid neoplasms are willing to let a computer program decide (randomization) whether they receive lower- or higher-intensity chemotherapy. Historically, treatment decision-making for patients with AML or myeloid neoplasms has divided patients into two categories, with patients considered fit receiving intensive "curative" chemotherapy, and patients considered unfit, such as older patients with a higher risk of early death from therapy, receiving non-intensive "palliative" therapy or no therapy. With the introduction of new treatment agents, it has become difficult to determine the difference between intensive and non-intensive therapy, especially for patients considered unfit for whom treatment-related side effects remain a concern. Treatment intensity is best identified through randomized trials but often patients are unwilling to undergo randomization due to preset beliefs. However, with improved supportive care and the awareness that new treatment agents may have similar risks as intensive therapy, it may be possible that more patients are willing to be randomized. This may help identify the best treatment intensity for less fit adults with AML or myeloid neoplasms, which may improve outcomes.
Waitlist Available
Has No Placebo
Fred Hutch/University of Washington Cancer ConsortiumJacob Appelbaum, MD, PhD
Image of Houston Methodist Neal Cancer Center in Houston, United States.

Hypomethylating Agents vs. Intensive Chemotherapy for Acute Myeloid Leukemia

18+
All Sexes
Houston, TX
This is a therapeutic intervention trial evaluating the clinical utility of a novel blood-based epigenetic biomarker-genome-wide 5-hydroxymethylcytosine (5hmC) in cell-free DNA (cfDNA)-for assessing measurable residual disease (MRD) in patients with newly diagnosed acute myeloid leukemia (AML). The study compares the efficacy of hypomethylating agent (HMA)-based therapy versus intensive induction chemotherapy, using the 5hmC biomarker to guide post-induction treatment decisions. Approximately 112 adult patients will be enrolled and assigned to treatment arms based on a stratified sampling scheme. Blood samples will be collected at defined intervals to assess MRD status. Primary endpoints include minimal residual disease (MRD) negativity rate, duration of remission, event-free survival (EFS), and overall survival (OS).
Phase 2
Waitlist Available
Houston Methodist Neal Cancer CenterShilpan Shah, MD
Image of Texas Children's Cancer and Hematology Center in Houston, United States.

Combination Therapy for Pediatric Acute Myeloid Leukemia

1 - 30
All Sexes
Houston, TX
This research study investigates the tolerability of substituting two cycles of chemotherapy into the standard pediatric acute myeloid leukemia (AML) chemotherapy treatment regimen for patients with newly diagnosed AML at intermediate-risk (IR) and high-risk (HR) of relapse. The goal is to achieve similar or better survival with chemotherapy cycles that are intensive but less likely to cause long-term complications. Patients will enroll on this trial at the end of their first induction cycle. The two cycles to be substituted are: * "Ida-FLA" (idarubicin+fludarabine/cytarabine) as Induction 2 * "VIA" (venetoclax+idarubicin+cytarabine) as Intensification 1 of the HR treatment regimen, and Intensification 2 of the IR treatment backbone. Researchers will evaluate side effects and outcomes for up to three years after enrollment. Participants will also have the opportunity to participate in optional research studies including patient surveys and blood and bone marrow sample testing.
Phase < 1
Recruiting
Texas Children's Cancer and Hematology Center
Have you considered Venclexta clinical trials? We made a collection of clinical trials featuring Venclexta, we think they might fit your search criteria.Go to Trials
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