RecruitingPHASE2INTERVENTIONAL

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

This study is for adults with a type of blood cancer called Chronic Lymphocytic Leukemia (CLL) that has come back after earlier treatment. Researchers want to see how effective and safe a combination of two medicines, venetoclax and obinutuzumab, is when given again to patients who have already had venetoclax. Venetoclax is an approved medicine for CLL. Participants will be put into one of two groups depending on when their CLL symptoms returned. There will be about 75 adults taking part across many locations worldwide. The study will look at how this treatment affects the disease and any side effects.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AbbVie

Enrolment target

Start

28 Mar 2022

Estimated completion

01 Jan 2029

Chronic Lymphocytic Leukemia (CLL)

What is this study about?

This study is for people who have Chronic Lymphocytic Leukemia (CLL), which is a type of cancer affecting white blood cells. CLL is the most common kind of leukaemia. Sometimes, even after treatment, CLL can return. This study is looking into a way to re-treat CLL using two medicines called venetoclax and obinutuzumab, which are both approved for treating CLL. The main aim is to see how well this combination works and if it's safe for people whose CLL has come back after they've already been treated with venetoclax along with another medicine.

Researchers want to understand how the disease changes during this treatment and what side effects people might experience. They will divide around 75 adult participants into two groups. The grouping depends on how long it has been since their CLL previously came back after their first treatment with venetoclax combined with an anti-CD20 antibody (and possibly other medicines).

By carefully watching how people respond to this treatment and noting any side effects, the study hopes to gather important information. This could help doctors better understand how to treat CLL that has returned, potentially offering more options for patients in the future.

Key takeaways

This study is for adults with a type of blood cancer called CLL that has come back.
It uses two medicines, venetoclax and obinutuzumab, in combination.
Participants must have had previous venetoclax treatment for their CLL.
The study will look at how well the treatment works and any side effects.
Taking part will involve regular hospital visits and various medical checks.

Who may be eligible?

You might be able to join this study if you are an adult who has been diagnosed with Chronic Lymphocytic Leukemia (CLL) and your doctor agrees that you need treatment for it.

Crucially, you must have completed an earlier course of treatment for your CLL using venetoclax combined with another specific type of medicine. After that earlier treatment, your CLL must have shown a good response, meaning it improved. Also, your CLL must have started to get worse again (or come back) at a certain time after your last venetoclax dose – either more than 24 months ago or between 12 and 24 months ago, depending on which group you might fit into.

However, you cannot join the study if you have received any other CLL treatment in between finishing your previous venetoclax-based treatment and now. This study is for adults aged 18 and over, and both men and women can take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am an adult (18 years or older).
I have been diagnosed with Chronic Lymphocytic Leukemia (CLL).
My doctor says I need treatment for my CLL now.
I have previously completed a treatment course for CLL that included venetoclax and another specific medicine.
My CLL improved after that previous treatment, but it has now worsened or returned.
I have not had any other CLL treatment since finishing my last venetoclax-based treatment.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive treatment over several months. You'll get obinutuzumab as an infusion into a vein (IV) and venetoclax as tablets you take by mouth. This treatment will be given in 28-day cycles. You will have 6 cycles of both medicines together, followed by a longer period of just venetoclax tablets, for a total treatment time of 12 to 24 cycles (about a year to two years).

Taking part will mean more hospital or clinic visits than someone receiving standard care. During these visits, the study team will do medical checks, draw blood for tests, ask about any side effects you might be having, and ask you to fill out questionnaires to understand how you are feeling and how the treatment is affecting you.

Potential risks and benefits

There could be potential benefits to taking part, such as receiving close medical attention and access to a specific treatment combination. However, there are also potential risks, including side effects from the medicines. The amount of doctor visits and tests might be more than usual for your standard care, which could be a burden. You are always free to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (58)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Moores Cancer Center at UC San Diego /ID# 230157
Verified postcode
La Jolla, United States· Recruiting
Winship Cancer Institute of Emory University /ID# 230643
Verified postcode
Atlanta, United States· Recruiting
Des Moines Oncology Research Association /ID# 232606
Verified postcode
Des Moines, United States· Completed
Dana-Farber Cancer Institute /ID# 230061
Verified postcode
Boston, United States· Recruiting
Henry Ford Hospital /ID# 230268
Verified postcode
Detroit, United States· Completed
St. Lukes Hospital of Duluth /ID# 250021
Verified postcode
Duluth, United States· Recruiting
Hattiesburg Clinic /ID# 233443
Verified postcode
Hattiesburg, United States· Recruiting
Summit Medical Group-Florham Park /ID# 244782
Verified postcode
Florham Park, United States· Completed
Regional Cancer Care Associates /ID# 244620
Verified postcode
Hackensack, United States· Recruiting
University of North Carolina /ID# 233313
Verified postcode
Chapel Hill, United States· Recruiting
Novant Health Presbyterian Medical Center /ID# 230201
Verified postcode
Charlotte, United States· Recruiting
Novant Health Forsyth Medical Center /ID# 249533
Verified postcode
Winston-Salem, United States· Recruiting

Common questions

What is CLL?

CLL stands for Chronic Lymphocytic Leukemia, which is a slow-growing cancer that affects a type of white blood cell called lymphocytes.

What are venetoclax and obinutuzumab?

These are both approved medicines used to treat CLL. Venetoclax is usually taken as a tablet, and obinutuzumab is given directly into a vein.

Why is this study being done?

The study aims to see how safe and effective a specific combination of venetoclax and obinutuzumab is for adults whose CLL has returned after previous venetoclax-based treatment.

How long will I be in the study?

The treatment part of the study will last between 12 and 24 cycles (about 1 to 2 years), depending on which group you are in.

Can I leave the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your future medical care.

How to find out more

ABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com 844-663-3742 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.