RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

This study is for adults with a type of blood cancer called Chronic Lymphocytic Leukemia (CLL) that hasn't been treated before. We're testing how safe and effective certain drug combinations are. Two main combinations are being looked at: venetoclax paired with obinutuzumab, and venetoclax paired with acalabrutinib. Participants will be divided into different groups, each receiving one of these combinations, sometimes with slightly different schedules. The medical team will closely monitor for any side effects and see how the disease responds. The study aims to help understand if these new approaches can be a good treatment option for CLL patients. It will involve regular hospital visits, blood tests, and questionnaires, lasting about two years.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

170

Start

05 Aug 2024

Estimated completion

01 Mar 2028

Chronic Lymphocytic Leukemia

What is this study about?

Chronic Lymphocytic Leukemia, often called CLL, is a common cancer that affects your white blood cells. When you have CLL, your body makes too many abnormal white blood cells, which can cause problems. This study is looking for better ways to treat adult patients who have not yet received treatment for their CLL.

The main goal of this research is to see how safe two drug combinations are: venetoclax with obinutuzumab, or venetoclax with acalabrutinib. Researchers also want to understand how well these treatments work in controlling the CLL. Doctors will be carefully watching for any side effects and how the cancer activity changes over time. By doing this, they hope to find effective and safe new options for people living with CLL.

About 170 adults from around the world will take part. Participants will be put into one of four groups, and each group will receive one of the drug combinations. The study will last for approximately 28 months, during which time your health will be regularly checked by the study team. This research is important because it could lead to improved treatments for CLL in the future.

Key takeaways

This study is for adults with previously untreated CLL.
It tests two drug combinations: venetoclax with obinutuzumab, or venetoclax with acalabrutinib.
The main focus is on the safety and effectiveness of these treatments.
Participation involves regular hospital visits, blood tests, and questionnaires.
The study aims to find better treatment options for CLL patients.

Who may be eligible?

To be part of this study, you generally need to be an adult over 18 who has been diagnosed with CLL that hasn't been treated before. This also includes a similar condition called small lymphocytic lymphoma (SLL).

You would need to be well enough to take part, meaning you can mostly look after yourself. Your body's organs, like your kidneys, would need to be working properly, and your blood counts should be stable, unless your CLL is affecting them. You should also not have any serious, uncontrolled infections or other specific conditions like Richter's transformation, which is a more aggressive form of CLL.

Quick self-check

Are you an adult (18 years or older)?
Have you been diagnosed with CLL (or SLL) that hasn't been treated yet?
Are you generally able to look after yourself and go about your daily activities?
Do you have good kidney function and stable blood counts (unless your CLL is causing the issue)?
Do you not have any serious, untreated infections or specific other conditions affecting your CLL?

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

What does participation involve?

If you join this study, you'll be one of approximately 170 adults with CLL. You'll be assigned to one of four groups, and you'll receive either venetoclax combined with obinutuzumab given through a drip, or venetoclax combined with acalabrutinib taken as tablets. The way you take venetoclax might start with a gradual increase in dose over five weeks, which is called a 'ramp-up'.

You'll need to attend regular visits at a hospital or clinic throughout the study. During these visits, the medical team will check your health with assessments, blood tests, and ask you about any side effects you might be having. You'll also be asked to fill out questionnaires. The total study duration is expected to be around 28 months, which is just over two years.

Potential risks and benefits

Taking part in any study has possible benefits and risks. You might benefit from receiving a new treatment for your CLL and having close medical monitoring. However, there's also a chance the treatment might not work for you, or you could experience side effects, some of which might be serious. The study treatments are still being investigated, and we don't know all the possible effects yet. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (70)

Arizona Oncology - Tucson - Rudasill /ID# 267552
Tucson, United States· Recruiting
Southern VA Health Care System /ID# 266254
Tucson, United States· Recruiting
UCSF FRESNO/Community Cancer Institute /ID# 270874
Clovis, United States· Recruiting
Valkyrie Clinical Trials /ID# 268151
Los Angeles, United States· Recruiting
Rocky Mountain Cancer Centers - Aurora /ID# 267549
Aurora, United States· Recruiting
Yale University School of Medicine /ID# 266224
New Haven, United States· Recruiting
Malcolm Randall V.A. Medical Center /ID# 267825
Gainesville, United States· Recruiting
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713
Jacksonville, United States· Recruiting
Mid Florida Hematology And Oncology Center /ID# 269159
Orange City, United States· Recruiting
Comprehensive Hematology Oncology /ID# 267644
St. Petersburg, United States· Recruiting
Springfield Clinic - First /ID# 270145
Springfield, United States· Recruiting
Northwest Cancer Center - Dyer Clinic /ID# 268478
Dyer, United States· Recruiting

+58 more sites — see the official record for the full list.

Common questions

What is CLL?

CLL stands for Chronic Lymphocytic Leukemia. It's a type of cancer that affects a certain type of white blood cell, which are part of your immune system.

What drugs are being tested?

This study is testing different combinations of three drugs: venetoclax, obinutuzumab, and acalabrutinib, to see how safe and effective they are for CLL.

How long will the study last?

The study is expected to last for about 28 months, which is a little over two years.

Will I have to go to the hospital often?

Yes, you will have regular visits to the hospital or clinic so the study team can monitor your health and the effects of the treatment.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, and this 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.