All studies
CompletedPhase I/IIInterventional

The ACCEPT study

Diffuse large B-cell lymphoma (DLBCL) is a fast-growing type of blood cancer affecting white blood cells. The standard NHS treatment is a mix of drugs known as R-CHOP, which combines chemotherapy with an antibody medicine. The ACCEPT trial tests whether adding a targeted drug named acalabrutinib to standard R-CHOP makes the treatment work better. Acalabrutinib works by blocking signals that cancer cells need to grow and survive. This early-phase trial aims to check what dose is safe, what side effects occur, and how well the combination clears the cancer. It is open to people aged 16 and older who have newly diagnosed DLBCL and have not yet received treatment. Taking part involves hospital visits, scans, taking daily capsules, and regular check-ups to monitor your health.

At a glance

Status
Completed
Phase
Phase I/II
Sponsor
University Hospital Southampton NHS Foundation Trust
Enrolment target
40
Start
01 Apr 2017
Estimated completion
02 Jan 2020

What is this study about?

Diffuse large B-cell lymphoma, or DLBCL, is a type of non-Hodgkin lymphoma. It causes your body to make abnormal B-cells, which are white blood cells that usually help fight off infections. Because these cells grow quickly, DLBCL needs prompt treatment. Currently, most people in the UK receive a combination of drugs called R-CHOP, which includes chemotherapy, a steroid, and a targeted antibody. While R-CHOP helps many people recover, doctors are searching for ways to make it even more effective.

The ACCEPT study is testing a newer targeted drug called acalabrutinib alongside regular R-CHOP. Acalabrutinib is a type of medicine known as a BTK inhibitor. It works like a switch, turning off key proteins that cancer cells rely on to divide and spread. Researchers hope that combining this targeted medicine with standard chemotherapy will hit the cancer from different angles at once.

Because this is an early-phase trial (Phase I/II), the main goals are to find the safest dose of acalabrutinib to give with R-CHOP, monitor any side effects, and see how well the combination works to shrink or remove the cancer. The results could help shape future treatments for people diagnosed with DLBCL in the UK.

Key takeaways

  • The ACCEPT trial tests adding a targeted drug (acalabrutinib) to standard R-CHOP chemotherapy.
  • It is for people aged 16 and over with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
  • Acalabrutinib is taken as daily capsules at home alongside hospital chemotherapy.
  • The main goals are to check safety, find the best dose, and see how well the combination works.
  • Taking part is voluntary, and you can stop at any point without losing your standard NHS care.

Who may be eligible?

This study is open to people aged 16 and older who have been newly diagnosed with diffuse large B-cell lymphoma (DLBCL) and have not yet started treatment. Because the trial tests a full course of treatment, you must be well enough to cope with combination chemotherapy and have a tumour that measures at least 15 millimetres so doctors can track changes. You must also be able to swallow capsules whole.

To ensure the treatment is safe for you, your heart, kidneys, and liver must be working reasonably well, and you will have blood tests and heart scans before joining to check this. You cannot take part if you have had a slow-growing (indolent) lymphoma in the past, or if the lymphoma started in your brain, spinal cord, or the centre of your chest (mediastinum). A hospital doctor will go through all the medical criteria with you to confirm if the study is suitable.

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. I am aged 16 or over.
  2. I have been newly diagnosed with diffuse large B-cell lymphoma (DLBCL).
  3. I have not yet had chemotherapy or other treatment for my lymphoma.
  4. I am able to swallow medicine capsules.
  5. I am generally fit enough to have combination chemotherapy.
Answer every question to see your result.

What does participation involve?

If you take part, you will receive standard R-CHOP therapy through a drip in the hospital alongside acalabrutinib, which is taken by mouth as capsules at home. Before starting, the trial team will perform baseline checks, including blood tests, physical exams, a heart scan (such as an echocardiogram), and imaging scans (like a CT or PET scan) to measure your lymphoma.

During treatment, you will attend the hospital regularly for your chemotherapy sessions and safety checks. The study team will closely monitor your blood counts, organ function, and any side effects. Treatment typically lasts several months, matching a standard course of chemotherapy. After treatment finishes, you will have follow-up visits and scans so the team can monitor your recovery and check how long the benefits last.

Potential risks and benefits

Taking part may help shrink your lymphoma, and the findings could help future patients facing the same condition. However, there is no guarantee that adding acalabrutinib will work better than standard care. You may experience side effects from the chemotherapy as well as specific side effects from acalabrutinib, such as headache, bruising, tummy upset, or a higher risk of infection. Your care team will monitor you closely and give medicines to help manage side effects. Joining the study is entirely voluntary, and you can choose to leave at any time without your regular NHS care being affected.

Locations (7)

  • Southampton General Hospital
    Approximate
    Southampton, England
  • Queen's Medical Centre
    Approximate
    Nottingham, England
  • Churchill Hospital
    Approximate
    Oxford, England
  • University College London Hospital
    City only
    London, England
  • Christie Hospital
    Unverified
    Manchester NO COUNTRY SPECIFIED, assuming England, England
  • St. James's University Hospital
    Approximate
    Leeds, England
  • Derriford Hospital
    Unverified
    Plymouth, England

Common questions

What is acalabrutinib and how do I take it?

Acalabrutinib is a targeted cancer medicine that blocks signals cancer cells need to multiply. It comes as a capsule that you swallow with water.

Will I still get normal chemotherapy?

Yes. All participants in this study receive standard R-CHOP chemotherapy alongside the study drug.

Do I have to pay to take part in this trial?

No. The trial medication and all study tests are provided free of charge through the NHS hospital running the trial.

What happens if I experience bad side effects?

Your medical team will check you regularly. If side effects become difficult, doctors can adjust your dose, pause the medicine, or stop the study treatment to protect your health.

Can I leave the study if I change my mind?

Yes. Taking part is completely your choice. You can withdraw at any time, and you will continue to receive the best standard NHS care.

How to find out more

Joshua Caddy

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

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