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Active not recruitingPHASE3INTERVENTIONAL

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

This research study is comparing two treatment combinations for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), which are types of blood cancer. One combination uses the medicines Ibrutinib and Venetoclax. The other uses Obinutuzumab and Chlorambucil. We want to find out which combination is more effective at preventing the cancer from getting worse, also known as 'progression-free survival.' The study aims to help doctors understand the best first treatment for patients with these conditions. By joining, you could help improve future care for others with CLL/SLL.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Enrolment target
211
Start
17 Apr 2018
Estimated completion
05 Apr 2029

Results

Results from this study

Posted March 2022

Results have been published for this study.

Primary outcome
Progression Free Survival (PFS)
PFS: time between date of randomization and date of disease progression, as assessed by IRC, or date of death due to any cause, whichever occurs first, regardless of use of subsequent anti-cancer therapy prior to PD or death using iWCLL2008 criteria : New enlarged lymph nodes \>15 mm, new hepatomegaly or splenomegaly, or other organ infiltrates, bone lesion, ascites or pleural effusion due to CLL; \>=50% increase in longest diameter (LDi) from nadir in existing lymph node (LDi \>15 mm) or \>=50% increase from nadir in sum of diameters of multiple nodes (and at least 1 node with LDi \>15 mm); \>=50% increase from nadir in enlargement of liver/spleen; \>=50% increase from baseline in lymphocyte count (ALC; to \>=5\*10\^9/L); or \>=50% increase from nadir in ALC in \>=2 serial assessments if ALC is \>=30000\*10\^9/L and lymphocyte doubling time is rapid unless considered treatment-related lymphocytosis; new cytopenia attributable to CLL; transformation to more aggressive histology.
Full results on the registry

What is this study about?

This study is about finding the best way to treat a type of blood cancer called chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) when someone is first diagnosed. These conditions affect your white blood cells. Doctors are comparing two different combinations of medicines to see which one works better.

The first treatment combination involves two medicines called Ibrutinib and Venetoclax. The second combination uses medicines known as Obinutuzumab and Chlorambucil. The main goal is to see which combination can stop the cancer from getting worse for the longest time. This is called 'progression-free survival' and is a key measure of how well a treatment is working.

By taking part in this study, you would be helping doctors and researchers understand which medicines are most effective as a first treatment for CLL and SLL. This knowledge is really important because it helps improve the care and outcomes for other people living with these conditions in the future. The study is run by doctors and reviewed by an independent committee to make sure it's fair and accurate.

Key takeaways

  • Compares two medicine combinations for newly diagnosed CLL/SLL.
  • Aims to find which treatment best stops cancer from growing.
  • Participation helps improve future care for others with CLL/SLL.
  • You'll be closely monitored by a healthcare team.
  • You can leave the study at any time without affecting your care.

Who may be eligible?

To join this study, you need to be an adult with a diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that needs treatment. You will also need to be at least 65 years old, OR if you are between 18 and 64, you have to meet at least one additional health condition, like certain kidney health scores or a specific illness rating.

Doctors will check your cancer to make sure it can be measured, for example, by looking at your lymph nodes on a scan. You also need to be well enough to take part in the study, with your daily activities not too limited by your illness.

You cannot join if you've already had medicine treatment for CLL or SLL. Also, if your cancer has a specific genetic change (called a 17p deletion or TP53 mutation above a certain level), or if you've had major surgery recently, you won't be able to participate. Bleeding problems or if your cancer has spread to your brain or spinal cord would also mean you can't join.

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.

  1. Are you an adult aged 18 or older with CLL or SLL that needs treatment?
  2. If you are under 65, do you have any specific health issues like certain kidney problems or an illness rating high enough to qualify?
  3. Have you NOT had any previous medicine treatment for your CLL or SLL?
  4. Are you generally well enough for daily activities, and is your cancer measurable on scans?
  5. Do you NOT have a specific genetic change (17p deletion or TP53 mutation above 10%) or other specific serious conditions like severe bleeding disorders?
Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully provided in this summary. However, generally, in studies like this, if you are eligible and agree to take part, you would be assigned to one of the two treatment groups. This would involve taking specific study medications, likely by mouth or through an injection/drip, for a set period. You would need to attend regular clinic visits for check-ups, blood tests, and scans to monitor your health and how well the treatment is working. The study team would explain the exact schedule of visits and tests. There would also be a follow-up period after your main treatment finishes to see how you are doing in the long term. The total duration of the study, including treatment and follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new or different treatment combination for your condition from a dedicated healthcare team. While new treatments can sometimes be more effective, there are always potential risks involved, including possible side effects from the medications. The study team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (88)

  • Norton Cancer Institute
    Verified postcode
    Louisville, United States
  • John Theurer Cancer Center
    Verified postcode
    Hackensack, United States
  • Novant Health
    Verified postcode
    Charlotte, United States
  • Institut - Jules Bordet
    Verified postcode
    Anderlecht, Belgium
  • ZNA Stuivenberg
    Verified postcode
    Antwerp, Belgium
  • Universitair Ziekenhuis Gent
    Verified postcode
    Ghent, Belgium
  • Virga Jessa Ziekenhuis
    Verified postcode
    Hasselt, Belgium
  • UZ Leuven Gasthuisberg
    Verified postcode
    Leuven, Belgium
  • Arthur J E Child Comprehensive Cancer Centre
    Verified postcode
    Calgary, Canada
  • Cross Cancer Institute
    Verified postcode
    Edmonton, Canada
  • Juravinski Cancer Centre
    Verified postcode
    Hamilton, Canada
  • The Ottawa Hospital - General Campus
    Verified postcode
    Ottawa, Canada

Common questions

What is chronic lymphocytic leukemia (CLL)?

CLL is a type of cancer that starts in white blood cells (lymphocytes) in the bone marrow, blood, and lymph nodes. It usually progresses slowly.

What is 'progression-free survival'?

This is a term used in cancer research to measure the length of time during and after treatment that a patient lives without their cancer getting worse.

What does a 'Phase 3' study mean?

Phase 3 studies compare a new treatment to standard treatments. They involve a larger number of people to check if the new treatment is better and to monitor side effects.

Are the medicines in this study already approved?

The medicines being studied (Ibrutinib, Venetoclax, Chlorambucil, Obinutuzumab) are generally approved treatments for CLL/SLL, but this study is looking at specific new combinations or how they work together for the first time.

What if I get side effects from the study medicines?

The study team will carefully monitor you for any side effects. They will provide care and guidance on how to manage them.

How to find out more

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

Discussion

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