Wales-based Cardiff and Vale University Health Board Helps Drive ‘VICTOR’ Trial Evaluating Venetoclax vs. Intensive

Wales-based Cardiff and Vale University Health Board Helps Drive ‘VICTOR’ Trial Evaluating Venetoclax vs. Intensive TrialsiteN

Blood cancer patients in Wales will gain access to a promising active lower intensity investigational therapy option via a clinical trial conducted at Cardiff and Vale University Health Board. Cancer Research UK is funding the VICTOR clinical trial investigating the efficacy and safety of a treatment targeting select groups of older patients afflicted with acute myeloid leukemia (AML). If the study therapy, a venetoclax-based treatment, demonstrates positive results in the future, patients with AML may be spared the more toxic impacts associated with intensive chemotherapy. Select AML patients in Wales have the opportunity to extend survival and improve quality of life.

The Disease: Acute Myeloid Leukemia 

Known as AML, this aggressive blood cancer impacts over 3,0000 people a year in the United Kingdom alone. When this blood-based cancer strikes younger patients often treatment involves intensive chemotherapy also known as IC. Although its fairly effective in inducing remission, and in some cases long-term cure, IC introduces severe short-term side effects such as the lowering of white blood cell count which can lead to fatal infection, mouth ulcers, nausea, vomiting and hair loss. Longer-term effects can include infertility, heart failure not to mention secondary cancers.

For more elderly patients or those patients with other health issues this approach can be too high risk. In this case of this class of patient, they are given treatment to control rather than cure the blood cancer.  Unfortunately, less than 50% of these patients go on to survive for over one year. What if there was a way to change this outcome?

The Treatment

Venetoclax, a new treatment, has been tested on AML patients who were not suitable for IC and the results thus far look promising. With novel cancer care delivery comes more precision and personalization as those patients with a particular biomarker, or type of AML known as NPM1 mutated, demonstrate particularly positive responses. According to the ISRCTN, entry response has been over 90% achieving some remission while over 75% of these specific AML patients remain alive after two (2) years. The net takeaway thus far: the results are as good if not better than those associated with IC alone.

The drug, marketed by both AbbVie and Genentech (Roche) in the USA and AbbVie worldwide, is sold under the brand names Venclexta and Venclyxto and is used to treat adults with chronic lymphocytic (CLL), small lymphocytic lymphoma (SLL) or of course acute myeloid leukemia (AML). See the FDA label

By attaching to the Bcl-2 protein, which is present in high amounts in CLL cancer cells, the drug helps the cells survive for longer periods of time in the body, helping to strengthen them against cancer medicines. Venetoclax helps to kill cancer cells thus all things being equal, contributing to a slow down in disease progression.

The Study

The VICTOR trial (ISRCTN15567173) involves the investigation as to a comparison between venetoclax and IC to determine if outcomes are comparable.

In this multi-center study, the Cardiff and Vale University Health Board participants as part of the Trials Acceleration Programme (TAP) Network, a network of 12 trial site centers across the UK. The study team seeks patients 60 years old and above healthy enough to receive IC. The sponsors could possibly reduce the age if the study drug evidences comparability to IC. While monitoring patients during treatment those not responding can be switched to other treatments or possibly even receive a stem cell transplant.

Patients in this study are randomized and placed into a group receiving either venetoclax combined with low dose cytarabine or the current standard of care (intensive chemotherapy) for AML. For more details, see the study disclosure

The group supports additional related studies such as the PROMise trial, investigating the clinical benefit of a new combination of drugs for exploring improvement of life for high-risk myelofibrosis patients, reports Barry and District News.

The Trial Site

The Cardiff and Vale University Health Board is one of 12 centers associated with TAP Network, which also involves a total of 40 centers participating in the VICTOR trial. This represents one of five such clinical trials involving blood cancer studies recently showcased by Cure Leukemia

The Cardiff and Vale University Health Board is one of the local health board of NHS Wales. Originating in 2009 based on the coming together of three NHS organizations, in the Cardiff and Vale of Glamorgan region of Wales, supporting a population of 445,000.

This health organization and associated trial site location is funded by the Welsh Government via Health and Care Research Wales—a partner with NHS, academic medical centers and other health and research stakeholders.

Funding

Funding for the TAP Network comes from Care Leukemia as well as Cancer Research UK

Lead Research/Investigator

Dr. Steve Knapper, Clinical Reader, Cardiff University School of Medicine, Co-Chief Investigator for the VICTOR Trial

Call to Action: Individuals in this region in Wales that have a loved one with AML that meets the inclusion criteria could consider this study.