Active not recruitingPHASE3INTERVENTIONAL

An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial

This research study is an opportunity for people who are already taking a specific cancer medicine called venetoclax in a different clinical trial. If venetoclax is still working well for them and they are tolerating it without serious problems, they can continue receiving it in this new study. The main goal is to gather more information about the long-term safety of venetoclax. By continuing to provide the medicine to those who benefit, researchers can better understand how it affects people over a longer period. This will help doctors decide who might benefit most from venetoclax in the future. It's suitable for various types of cancer, including certain leukaemias and lymphomas.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

165

Start

06 Sep 2019

Estimated completion

01 Aug 2027

Chronic Lymphocytic Leukemia Acute Myeloid Leukemia Multiple Myeloma Non-Hodgkin's Lymphoma Acute Lymphoblastic Leukemia Cancer

What is this study about?

This study is a continuation for people who are already on a particular cancer treatment called venetoclax as part of another clinical trial. Think of it like this: if you're taking a new medicine in a trial and it's really helping you, and you're not having serious side effects, this study gives you the chance to keep taking that medicine. The main reason for this continued study is to understand the long-term effects of venetoclax. Doctors want to see if the medicine remains safe and helpful over many months or even years.

Venetoclax is a treatment used for several types of cancer, including Chronic Lymphocytic Leukaemia (CLL), Acute Myeloid Leukaemia (AML), Multiple Myeloma, Non-Hodgkin Lymphoma, and Acute Lymphoblastic Leukaemia (ALL). By allowing current participants to continue, researchers can collect valuable information on how the drug works in the body over time, its potential side effects when taken for extended periods, and how people generally cope with the treatment.

This kind of study is really important because it helps doctors and researchers build a complete picture of a new medicine. Understanding both its benefits and any possible long-term issues is crucial for making sure that safe and effective treatments are available to everyone who needs them in the future. It also means that patients who are currently benefiting from venetoclax can continue their treatment without interruption.

Key takeaways

This study is for people already taking venetoclax in another trial.
It allows you to continue receiving venetoclax if it's working for you.
The main aim is to gather long-term safety information about the medicine.
It's open to people with specific blood cancers and lymphomas.
You'll be closely monitored by a medical team throughout your participation.

Who may be eligible?

To be able to join this study, you must already be taking part in another clinical trial where you are receiving venetoclax. The medicine must be helping you, and you must be tolerating it well, meaning you're not having severe or unmanageable side effects. This study is open to both men and women, of any adult age.

If you are a man, you must agree not to donate sperm while you are in the study. If you are a woman, you must not be pregnant or breastfeeding when you join the study. These are standard precautions in many clinical trials to protect against potential risks to unborn babies or infants. Otherwise, there are no other specific reasons that would prevent you from joining this study if you meet the main criteria.

Quick self-check

Are you currently taking venetoclax in another clinical trial?
Is venetoclax helping your condition and are you tolerating it well?
If you are a man, are you willing to avoid sperm donation during the study?
If you are a woman, are you not pregnant or breastfeeding?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study means you'll continue to receive venetoclax, the same medicine you've been taking in your previous trial. The study team will regularly check how you're feeling and how the medicine is affecting you. This will involve regular visits to the clinic, where you might have blood tests, physical examinations, and discussions about any side effects or changes you've noticed. The frequency of these visits and tests will be discussed with you by the study team.

The total duration of your participation in this extension study will depend on how you respond to the treatment and whether you continue to benefit from it. There isn't a fixed end date for everyone, and it will be determined by your individual health and the advice of the study doctor. You will be closely monitored throughout.

Potential risks and benefits

The main benefit of joining this study is that you can continue to receive venetoclax if it's currently helping your cancer and you're tolerating it well. This means your treatment won't be interrupted. As with any medicine, there are potential risks, primarily related to the known side effects of venetoclax, which you would already be familiar with from your previous trial. The study aims to monitor these effects over a longer period. You will be closely watched by the medical team, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (56)

University of Arizona Cancer Center - Tucson /ID# 210548
Tucson, United States
UCLA Santa Monica Hematology Oncology /ID# 210551
Los Angeles, United States
Ingalls Memorial Hosp /ID# 210553
Harvey, United States
Dana-Farber Cancer Institute /ID# 215360
Boston, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 231132
Ann Arbor, United States
Dartmouth-Hitchcock Medical Center /ID# 210555
Lebanon, United States
Swedish Medical Center - Seattle /ID# 213120
Seattle, United States
Royal Prince Alfred Hospital /ID# 239557
Camperdown, Australia
St George Hospital /ID# 225589
Kogarah, Australia
Liverpool Hospital /ID# 225591
Liverpool, Australia
Peter MacCallum Cancer Ctr /ID# 210559
Melbourne, Australia
Fiona Stanley Hospital /ID# 239480
Murdoch, Australia

+44 more sites — see the official record for the full list.

Common questions

What is venetoclax?

Venetoclax is a medicine used to treat certain types of cancer, particular blood cancers like leukaemia and lymphoma. It works by targeting specific proteins in cancer cells.

Why is this study only for people already taking venetoclax?

This study is a continuation study, designed for people who have already been receiving venetoclax in another clinical trial and are benefiting from it. It's to learn about the long-term effects.

What cancers is this study for?

This study includes people with different types of cancer, such as Chronic Lymphocytic Leukaemia, Acute Myeloid Leukaemia, Multiple Myeloma, Non-Hodgkin Lymphoma, and Acute Lymphoblastic Leukaemia.

Will I get a placebo (dummy drug) in this study?

No, if you join this study, you will continue to receive venetoclax. It's not designed to compare venetoclax against a placebo.

How long will I be in this study?

There isn't a set time limit; you will continue in the study for as long as venetoclax is helping you and you are tolerating it well, as decided by your study doctor.