About the SKYGLO clinical study

Clinical studies help to continually improve available options, and help determine if potential treatments work for everyone. So we’re running the SKYGLO clinical study to learn about the effects of an approved LBCL treatment called Pola-R-CHP when combined with an investigational drug.

Everyone who takes part in SKYGLO will be given Pola-R-CHP, undergo regular health monitoring, and contribute to research that may help others with LBCL in the future.

What is a clinical study?

Clinical studies (also known as clinical trials) are carefully controlled scientific investigations that help us answer questions like:

Does an investigational drug work?

Does it cause any unwanted effects?

Does it work better than existing options?

Thousands of people all around the world take part in clinical studies every year. The results of these studies must be approved by health authorities before a drug or treatment can be used by the general public. Without clinical studies, advances in healthcare simply wouldn’t be possible.

Who is eligible for SKYGLO?

We’re looking for 1,130 people to join SKYGLO who:

Are aged between 18 and 80

Have been diagnosed with LBCL

Have not yet received treatment for their LBCL

Trial support line

If you think you may be eligible and would like to know more, please call the trial support line on (888) 662-6728 or visit our website to get in touch. We'll be happy to help.

What SKYGLO will involve

If you’re eligible and would like to take part, your total time in the study will depend on how your cancer responds to your assigned study drugs. This could range from 1 day to more than 65 months, as shown.

Screening period

Up to 4 weeks

We’ll first carry out some tests to make sure that you and SKYGLO are a good fit.

Treatment period

About 6 months

If you’re eligible and you decide to join, you’ll randomly be assigned to be given either:

Pola-R-CHP in combination with the investigational drug (50% chance)

Pola-R-CHP on its own (50% chance)

Follow-up period

Up to 5 years

We’ll ask you to come to the study clinic and/or phone you to check how you’re feeling at least once every 3 months for the next 2 years, and then every 6 months for the following 3 years.

If you join SKYGLO, you’ll have to attend the study clinic around 30 times. These visits will allow us to monitor your health with assessments such as:

Blood tests

Physical examinations

Tumor imaging

Questionnaires

Participant rights and compensation

If you decide to take part, you can leave the study at any time without having to give a reason and without any impact on your regular healthcare. Health monitoring and the study drugs will be provided at no cost to you, regardless of your insurance status. You may be compensated for each study visit that you attend. This will depend on the local regulations of your study clinic.

Our commitment to diversity, equity, and inclusion (DEI)

Everyone deserves access to medical breakthroughs, and these breakthroughs must work for everyone. SKYGLO is being conducted across the world, including in locations with underrepresented populations. The study sponsor has partnered with patient advocacy groups to raise awareness of the study in these communities. We’ve also made our SKYGLO information brochure available in multiple languages.

At your screening visit we’ll record your demographic information. This information is incredibly helpful because it allows us to see if drugs work differently across different ages, genders, and races/ethnicities.