Active not recruitingPHASE3INTERVENTIONAL

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

This study, called ELEVATE-TN, looked at new ways to treat Chronic Lymphocytic Leukemia (CLL) in people who hadn't received treatment yet. Researchers wanted to find out if medicines called acalabrutinib and obinutuzumab, used alone or together, worked better than an older treatment (obinutuzumab and chlorambucil). They measured how long people lived without their cancer getting worse to see which treatment was most effective. The study involved 535 patients across 18 countries. The results helped doctors understand more about treating CLL and showed that acalabrutinib could be a good option for people newly diagnosed with this type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Acerta Pharma BV

Enrolment target

535

Start

26 Jun 2015

Estimated completion

30 Sep 2025

Chronic Lymphocytic Leukemia

What is this study about?

Imagine your body's immune system, which fights off infections, having a problem where certain white blood cells (B cells) grow out of control. This is what happens in Chronic Lymphocytic Leukemia (CLL). For people recently diagnosed with CLL who haven't had treatment yet, doctors are always looking for the best possible ways to help. This study, called ELEVATE-TN, aimed to do just that.

The main goal was to compare a newer drug combination (acalabrutinib with obinutuzumab) against a more established one (obinutuzumab with chlorambucil). Researchers wanted to see which combination was better at keeping the CLL from getting worse. They also looked at acalabrutinib on its own. They tracked how long people lived without their cancer progressing, how many people responded to the treatment, and how long it was before they needed another treatment. They also looked at overall survival.

This was a large, international study involving 535 patients who were randomly assigned to get one of the treatments. The study has now finished enrolling patients, but those who are benefiting from the treatment are still being monitored. The findings from ELEVATE-TN have provided important information to doctors and patients about effective treatment options for people newly diagnosed with CLL.

Key takeaways

The study explored new treatments for CLL.
It compared different drug combinations in previously untreated patients.
Acalabrutinib, alone or with obinutuzumab, was compared to older treatments.
The main goal was to see which treatment best prevented cancer progression.
Results have helped improve understanding of CLL treatment options.
The study has finished enrolling patients but is still monitoring participants.

Who may be eligible?

To join this study, people generally needed to be over 65 years old. If someone was between 18 and 64, they could still join if they had certain health conditions, like kidney issues or other medical problems which were scored on a specific health scale.

All participants had to have a confirmed diagnosis of CD20+ CLL and had not received any previous treatment for it. Their CLL also needed to be active, meaning it was causing problems like low blood counts, a very large spleen, swollen lymph nodes, or quick increases in white blood cell count. They also needed to be well enough to take part in a study, meaning they could carry out most of their daily activities without much trouble.

Quick self-check

Are you 65 years old or older?
If you are younger than 65 (but over 18), do you have kidney problems or other significant health issues?
Have you been diagnosed with CD20+ CLL?
Have you had no previous treatment for your CLL?
Are your CLL symptoms active (e.g., low blood counts, large spleen, swollen lymph nodes)?
Are you generally well enough to go about your daily life?

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

What does participation involve?

This study involved taking different medications, either acalabrutinib (possibly along with obinutuzumab) or obinutuzumab with chlorambucil. Participants were randomly assigned to one of these treatment groups. The study has finished enrolling new patients, but those who joined are still being monitored over time. If a patient's cancer got worse while on certain treatments, they might have been allowed to switch to acalabrutinib. The exact duration of treatment and follow-up would depend on the individual's response and the study's ongoing monitoring phase, but generally, these kinds of studies involve regular check-ups and tests over several years.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to new medications that might be more effective than standard treatment. However, there are also potential risks, including side effects from the medications, which could range from mild to serious. It's important to remember that not everyone will benefit, and some may experience side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (155)

Research Site
Goodyear, United States
Research Site
Phoenix, United States
Research Site
Anaheim, United States
Research Site
Los Angeles, United States
Research Site
Los Angeles, United States
Research Site
Los Angeles, United States
Research Site
Oxnard, United States
Research Site
Palo Alto, United States
Research Site
Aurora, United States
Research Site
Lone Tree, United States
Research Site
Washington D.C., United States
Research Site
Fort Myers, United States

+143 more sites — see the official record for the full list.

Common questions

What is Chronic Lymphocytic Leukemia (CLL)?

CLL is a type of cancer that affects white blood cells called lymphocytes. These cells are part of your immune system.

What are acalabrutinib, obinutuzumab, and chlorambucil?

These are different medicines used to treat CLL. Acalabrutinib is a newer drug, while obinutuzumab and chlorambucil are also used in CLL treatment, sometimes called 'chemoimmunotherapy'.

Who was this study for?

This study was for people diagnosed with CLL who had never received treatment for their cancer before.

What was the main purpose of the study?

The main purpose was to see if newer drug combinations worked better than older ones at controlling CLL and preventing it from getting worse.

Is this study still enrolling new patients?

No, this study finished enrolling new patients in 2017, but it is still monitoring those who participated.