CompletedPhase II/IIIInterventional

ENRICH Ibrutinib for untreated mantle cell lymphoma

Mantle cell lymphoma is a rare type of blood cancer that affects white blood cells. The standard treatment for older adults usually combines chemotherapy with an antibody drug called rituximab. While chemotherapy can be effective, it often causes difficult side effects that can be hard on older patients. The ENRICH clinical trial is investigating whether replacing chemotherapy with a targeted therapy drug called ibrutinib is safer and more effective. Ibrutinib works differently from chemotherapy; it blocks specific signals that cancer cells rely on to grow and survive. Participants are placed by chance into one of two groups. One group receives the standard chemotherapy with rituximab, while the other takes daily ibrutinib capsules with rituximab. Researchers hope this targeted approach will keep the cancer under control for longer while helping patients maintain a good quality of life.

At a glance

Status

Completed

Phase

Phase II/III

Sponsor

University Hospitals Plymouth NHS Trust

Enrolment target

400

Start

24 Nov 2015

Estimated completion

30 Jun 2021

Mantle cell lymphoma (MCL)

What is this study about?

Mantle cell lymphoma is a condition where white blood cells called B-lymphocytes multiply out of control, gathering in the lymph nodes and other parts of the body. For older adults, standard care typically involves chemotherapy regimens such as CHOP or bendamustine, paired with rituximab. While these combinations can push the cancer into remission, traditional chemotherapy attacks healthy growing cells alongside cancerous ones. This can lead to exhaustion, low blood counts, increased risk of infections, and strain on the heart and other organs.

The ENRICH trial aims to discover if a gentler, more targeted approach can achieve equal or better results. Instead of using standard chemotherapy drugs, half of the trial participants take ibrutinib. Ibrutinib is a targeted capsule that blocks a protein called BTK, which mantle cell lymphoma cells need to stay alive. By disabling this protein, the drug helps prevent the cancer cells from dividing, potentially without many of the harsh physical side effects seen with chemotherapy.

Because this is a randomised trial, a computer system fairly divides volunteers into two groups. One group receives standard NHS chemotherapy alongside rituximab, and the other receives ibrutinib alongside rituximab. Comparing these two treatments directly allows doctors to measure which approach keeps the disease away longer and how each affects everyday wellbeing.

This trial is vital because it could change the way mantle cell lymphoma is treated across the NHS. If ibrutinib proves successful, older adults may be offered an effective daily tablet treatment rather than having to endure intensive hospital-based chemotherapy.

Key takeaways

Open to adults aged 60 and older with untreated mantle cell lymphoma.
Tests whether targeted ibrutinib capsules can replace traditional chemotherapy.
Patients are randomly assigned to either ibrutinib plus rituximab or chemotherapy plus rituximab.
Aims to find a kinder, more manageable treatment that keeps cancer away longer.
Taking part is voluntary, and you are free to withdraw at any point.

Who may be eligible?

This trial is open to men and women aged 60 and over who have been newly diagnosed with mantle cell lymphoma (stage II, III, or IV) that now requires treatment. To take part, you must not have had any previous cancer treatments for this lymphoma, although having had a very brief course of steroids (up to seven days) or focused radiotherapy to ease symptoms is allowed.

You should be reasonably active and able to look after yourself day-to-day (able to walk and carry out light activities, known medically as an ECOG score of 0 to 2). Routine blood tests must show that your liver and kidneys are functioning adequately, and your bone marrow must be producing enough healthy blood cells.

Finally, your heart needs to be healthy enough to safely handle the trial treatments. Because these therapies can temporarily lower your immune system, you must also be willing to take standard preventive medicines, such as antibiotics, to protect against chest infections.

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.

You are 60 years of age or older.
You have been diagnosed with mantle cell lymphoma (stage II, III, or IV).
You have not had previous chemotherapy or standard drug treatment for your lymphoma.
You are generally active and able to manage your day-to-day personal care.
Your heart, liver, and kidneys are in good working order.

Answer every question to see your result.

What does participation involve?

If you decide to join the study, you will first have screening tests, including blood tests, physical checks, and a CT scan to confirm your general health. You will then be placed by chance into one of two treatment groups. If you are in the chemotherapy group, you will attend the hospital day unit every few weeks to receive rituximab and chemotherapy through a vein, along with steroid tablets. If you are in the targeted group, you will take ibrutinib capsules by mouth once a day at home, alongside rituximab infusions at the hospital.

During treatment, you will visit the hospital clinic regularly for health check-ups, blood tests, and monitoring of any side effects. You will also have periodic scans to see how well the cancer is responding. Chemo treatment usually lasts about six months, whereas ibrutinib can be taken long-term for as long as it continues to work. After active treatment ends, the study team will continue to follow your health over several years through routine clinic appointments.

Potential risks and benefits

Taking part may give you access to a targeted therapy that could control your cancer with fewer chemotherapy-related side effects. However, there is no guarantee that ibrutinib will work better than standard care. Both treatments carry side effects: chemotherapy commonly causes fatigue, nausea, hair loss, and low resistance to infections, while ibrutinib can cause loose stools, muscle aches, mild bleeding, or an irregular heartbeat. Your medical team will monitor you very closely throughout the trial. Participation is entirely voluntary, and you can change your mind and leave the study at any time without your regular NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Derriford Hospital (lead hospital)
City only
Plymouth, England

Common questions

Will I definitely receive ibrutinib if I join?

No. A computer will randomly assign you to either the ibrutinib group or the standard chemotherapy group. This is the fairest way to compare the two treatments.

Is ibrutinib a type of chemotherapy?

No. Ibrutinib is a targeted medicine known as a BTK inhibitor. It works by blocking specific signals inside lymphoma cells, rather than attacking all fast-growing cells like chemotherapy does.

Will taking part cost me anything?

No. The trial medication, extra tests, and hospital appointments are provided free of charge through the NHS and the trial sponsor.

Can I carry on taking my normal everyday medicines?

Most medicines are fine, but some drugs (such as certain blood thinners or herbal supplements) can interact with ibrutinib. Your study doctor will review all your regular medicines beforehand.

What happens if my lymphoma gets worse during the trial?

If tests show the treatment is no longer working, you will stop the trial medicine immediately and your doctor will discuss standard alternative NHS treatments with you.

How to find out more

Claire Scully

enrich@plymouth.ac.uk +44 1752 437513 Official trial record

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