Venclexta

Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia + 2 more

Treatment

4 FDA approvals

20 Active Studies for Venclexta

What is Venclexta

Venetoclax

The Generic name of this drug

Treatment Summary

Venetoclax 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.

Venclexta

is the brand name

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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 Patients

Venetoclax 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 body

Venetoclax 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 Risk

Venetoclax 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?

5

Patient 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.

5

Patient 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 University of California Davis Comprehensive Cancer Center in Sacramento, United States.

Olutasidenib + Azacitidine for Acute Myeloid Leukemia

18+
All Sexes
Sacramento, CA

This phase II trial studies how well giving olutasidenib with azacitidine, followed by olutasidenib maintenance, works in treating patients with IDH1-mutated acute myeloid leukemia (AML) who have received prior treatment with venetoclax plus a hypomethylating agent (HMA-Ven). Olutasidenib and azacitidine may inhibit the growth of cancer cells by blocking certain enzymes required for cell growth. Maintenance therapy can help prevent or delay cancer from coming back. Olutasidenib with azacitidine followed by olutasidenib maintenance may be effective in treating patients with IDH1-mutated AML who have received prior HMA-Ven.

Phase 2
Recruiting

University of California Davis Comprehensive Cancer Center

Brian Jonas, MD

Image of University of Virginia in Charlottesville, United States.

CD33 FPBMC for Acute Myelogenous Leukemia

18+
All Sexes
Charlottesville, VA

The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-CD33 bispecific antibody (CD33Bi) armed fresh peripheral blood mononuclear cells (CD33Bi FPBMC) for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) where they still have detectable disease ("MRD+") after some treatment. Participants receive 4 weekly doses of CD33 FPBMC by intravenous infusion followed by 4-6 weeks of standard treatment with a hypomethylating agent (type of treatment such as decitabine or azacitidine) and possibly a drug called venetoclax. This is considered 1 cycle of study treatment and may be repeated up to 4 times during the study.

Phase 1
Recruiting

University of Virginia

Daniel Reed, MD

Image of The University of Arizona Cancer Center in Tucson, United States.

DLI-X for Leukemia

Any Age
All Sexes
Tucson, AZ

The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone. We hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).

Phase 1
Waitlist Available

The University of Arizona Cancer Center

Emmanuel Katsanis, MD

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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, MD

Incyte 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
Recruiting

City of Hope Medical Center (+6 Sites)

Alexey V Danilov

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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, MD

Stemline Therapeutics, Inc.

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