Active not recruitingPHASE3INTERVENTIONAL

A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

This research study is about a type of blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL). Specifically, it focuses on a form called non-germinal center DLBCL which hasn't been treated yet. We are testing a new medicine called acalabrutinib, in combination with a common chemotherapy treatment known as R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). The study compares this new combination against R-CHOP plus a dummy pill (placebo). We want to find out if adding acalabrutinib makes the treatment more effective and safe for people aged 18 to 75. It’s a ‘double-blind’ study, meaning neither patients nor their doctors will know whether they're getting acalabrutinib or the placebo.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Acerta Pharma BV

Enrolment target

611

Start

08 Oct 2020

Estimated completion

22 Feb 2027

Diffuse Large B-Cell Lymphoma

What is this study about?

This study is a Phase 3 clinical trial, which means it's one of the final stages of testing a new treatment. We are focusing on a specific type of blood cancer called Diffuse Large B-Cell Lymphoma (DLBCL), especially the 'non-germinal center' kind, in people who haven't received treatment for it before. It’s a big step to see if a new approach can become a standard treatment.

The main aim is to see if adding a new drug called acalabrutinib to a standard chemotherapy treatment, known as R-CHOP, works better than R-CHOP alone. R-CHOP consists of several medicines: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. By comparing the new combination with the standard one, we can understand if patients benefit more from the addition of acalabrutinib in terms of how well the treatment fights the cancer and how safe it is overall.

Participants in the study will be randomly assigned to one of two groups, like flipping a coin. One group will get acalabrutinib plus R-CHOP, and the other will get a dummy pill (placebo) plus R-CHOP. Neither you nor your study doctor will know which group you are in. This helps us get unbiased results to truly understand the effects of acalabrutinib. We hope this research will lead to better treatment options for people with this type of lymphoma.

Key takeaways

This study tests adding a new drug (acalabrutinib) to standard chemotherapy (R-CHOP) for a specific type of untreated lymphoma.
It aims to see if the new combination is more effective and safe.
Participants will be randomly assigned to receive either acalabrutinib or a dummy pill, both with R-CHOP.
Your overall health will be closely monitored throughout the study.
This is a Phase 3 trial, a crucial step in testing new treatments.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would generally need to be between 18 and 75 years old and have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma that is of the 'non-germinal center' type. Importantly, you must not have received any previous treatment for this specific lymphoma. Your overall health and how well your body systems are working (like your liver, kidneys, and blood counts) would also be checked to make sure you are well enough to take part.

There are some reasons why you might not be able to join. For example, if you have certain other serious health conditions, particularly severe heart problems, a history of certain bleeding issues, or specific types of other cancers, you might be excluded. If the lymphoma has spread to your brain or spinal cord, or if you've recently had a stroke, you also wouldn't be able to participate. This is to ensure the safety of everyone taking 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.

Are you between 18 and 75 years old?
Have you been diagnosed with 'non-germinal center' Diffuse Large B-Cell Lymphoma?
Have you not received any treatment for your lymphoma yet?
Are your heart, kidneys, and other major organs generally working well?
Do you not have certain serious other medical conditions, like severe heart disease or recent stroke?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new drug (acalabrutinib) or a dummy pill (placebo), along with the standard R-CHOP chemotherapy. Both the new drug/placebo and the R-CHOP are given over several cycles. You would have regular visits to the hospital for treatments, blood tests, physical exams, and other assessments to check how you’re doing and if the treatment is working. These visits might include scans to track the lymphoma.

The main treatment phase could last several months, followed by a period where regular check-ups continue to monitor your health and the long-term effects of the treatment. The total duration of follow-up could extend beyond the active treatment, allowing doctors to understand the full impact of the new combination. During the study, it would be important to use effective birth control if applicable, and for a period after the last dose of certain medications.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to receive a new treatment that isn't widely available yet, which could potentially be more effective than standard treatment alone. However, there's no guarantee it will work for everyone, and you might experience side effects from the new drug or the chemotherapy. These side effects can range from mild to serious. The research team will carefully monitor your health throughout the study to manage any 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 (243)

Research Site
Verified postcode
Tucson, United States
Research Site
Verified postcode
Little Rock, United States
Research Site
Verified postcode
Irvine, United States
Research Site
Verified postcode
Aurora, United States
Research Site
Verified postcode
Norwich, United States
Research Site
Verified postcode
Fort Myers, United States
Research Site
Verified postcode
Orlando, United States
Research Site
Verified postcode
St. Petersburg, United States
Research Site
Verified postcode
Tallahassee, United States
Research Site
Verified postcode
West Palm Beach, United States
Research Site
Verified postcode
Fort Wayne, United States
Research Site
Verified postcode
Des Moines, United States

Common questions

What is Diffuse Large B-Cell Lymphoma?

It's a type of cancer that affects white blood cells called lymphocytes, which are part of your immune system. It can grow quickly and needs treatment.

What is R-CHOP?

R-CHOP is a common combination of several chemotherapy drugs and a steroid used to treat this type of lymphoma.

What is acalabrutinib?

Acalabrutinib is a newer drug that works differently from chemotherapy. It targets specific signals within cancer cells to stop them from growing and surviving.

Why is it 'double-blind'?

Being 'double-blind' means neither you nor your doctor will know if you're getting the new drug or a dummy pill. This helps us get the most accurate results about the treatment's true effects without any bias.

Will I still get standard treatment?

Yes, everyone in this study will receive the standard R-CHOP chemotherapy. The study is investigating if adding acalabrutinib (or a placebo) to R-CHOP makes a difference.