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New hope for lymphoma patients: trial pits novel drugs against standard chemo

NCT ID NCT05848765

Disease control Sponsor: University of Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial compares standard chemotherapy with newer drug combinations for people whose follicular lymphoma has returned or stopped responding to treatment. About 284 participants will receive either standard therapy or one of several experimental regimens, including a bispecific antibody and an immunomodulatory drug. The goal is to see if the new approaches lead to better cancer control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epcoritamab, Lenalidomide, Rituximab, Obinutuzumab, Bendamustine, Vincristine, Doxorubicin, Cyclophosphamide, Prednisone
What this could lead to
If successful, this trial could identify new treatment combinations that work better than standard chemotherapy for people with relapsed follicular lymphoma.
What could go wrong
This is a phase II trial, so results are still early. The new treatments may not prove more effective or could have unexpected side effects. The second experimental drug is not yet confirmed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 284 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma (biopsy within 3 months of trial entry) 2. Aged 18 years or over 3. Advanced disease that in the opinion of the treating physician requires treatment 4. Patient suitable for standard available therapy at the Investigator's discretion 5. Prior therapy with at least one line of immunochemotherapy. Previous radiotherapy at any time is permitted and will not count as a line of therapy. Previous rituximab monotherapy is also permitted as long as patients have at any time also received at least one line of immunochemotherapy 6. Assessable disease by PET-CT (at least one involved node with long diameter \>1.5cm, or extranodal lesion \>1cm ) 7. ECOG performance status of 0, 1 or 2 at trial entry 8. Adequate organ function defined as; i. ANC ≥ 1.0 x 109/L (growth factor use is permitted) ii. Platelet count ≥ 75 x 109/L, or ≥ 50 x 109/L if bone marrow infiltration or splenomegaly iii. ALT and AST level ≤3 x ULN iv. Direct bilirubin level ≤ 2 x ULN, unless due to Gilbert's syndrome v. CrCl ≥ 50mL/min (by Cockcroft-Gault formula) vi. PT, INR and aPTT ≤ 1.5 x ULN, unless receiving anticoagulation vii. LVEF within normal limits by MUGA or echocardiography 9. Able to provide written informed consent 10. Women of childbearing potential (or their partners) must use an effective form of contraception Exclusion Criteria: 1. Current (or within 1 year) transformation to high grade lymphoma, including grade 3b follicular lymphoma (patients with historical high-grade transformation over 1 year ago are eligible) 2. Non-Fluorodeoxyglucose (FDG) avid disease 3. Prior allogenic stem cell transplantation (SCT) or solid organ transplant 4. Prior treatment with lenalidomide 5. Treatment with CAR-T therapy within 100 days of starting trial treatment 6. SCT or maintenance therapy planned within 24 weeks of starting treatment (patients planning SCT/maintenance after at least 24 weeks of treatment are eligible) 7. Immunochemotherapy with a platinum-containing regimen planned 8. Known serological positivity for HIV or uncontrolled HCV 9. Hepatitis B surface antigen (HBsAg) positive and/or detectable viral DNA. Patients positive for Hepatitis B core antibody (anti-HBc) but viral DNA negative are eligible 10. Other malignancy within 2 years of enrolment, excepting cervical carcinoma stage 1B or less, non-invasive basal cell or squamous cell skin carcinoma, non-invasive, superficial bladder cancer, prostate cancer with a current PSA level \<0.1ng/mL, any curable cancer with a CR of \> 2 years duration 11. Active systemic infection requiring treatment 12. Current or prior CNS involvement with lymphoma 13. History of allergy or anaphylaxis to anti-CD20 monoclonal antibody therapy 14. Known hypersensitivity to any of the experimental arm IMPs. Patients with a known hypersensitivity to a control arm regimen may still be eligible if they have no hypersensitivity to other potential control arm IMPs. 15. Serious medical or psychiatric illness likely to interfere with participation in this clinical study 16. Recent cancer treatment (chemotherapy, immunotherapy, biological therapy) within 4 weeks of starting trial treatment; systemic steroid treatment (prednisolone \> 10mg daily (or equivalent)) within 7 days of cycle 1 day 1 dosing 17. Unwilling to use appropriate contraception methods whilst on study treatment and for 12 months following end of treatment (or 18 months for female patients whose ICT regimen contains obinutuzumab) 18. Women who are pregnant or breastfeeding 19. Prior treatment with the experimental therapy under investigation 20. Major surgery within 30 days of starting treatment 21. Severe arrhythmias, heart failure, previous myocardial infarction, acute inflammatory heart disease for ICT regimen containing doxorubicin, or severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease for ICT regimen containing rituximab

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Conditions

The condition(s) this trial relates to.

follicular lymphoma lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Refractory follicular lymphoma Relapsed follicular lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Belfast Health & Social Care Trust

    NOT_YET_RECRUITING

    Belfast, United Kingdom

  • Blackpool Teaching Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Blackpool, United Kingdom

  • Cambridge University Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Cambridge, United Kingdom

  • Cardiff and vale University LHB

    NOT_YET_RECRUITING

    Cardiff, United Kingdom

  • Croydon Health Services NHS Trust

    NOT_YET_RECRUITING

    Croydon, United Kingdom

  • Guy's and St Thomas' NHS Foundation Trust

    NOT_YET_RECRUITING

    London, United Kingdom

  • King's College Hospital NHS Foundation Trust

    NOT_YET_RECRUITING

    London, United Kingdom

  • NHS Grampian

    NOT_YET_RECRUITING

    Aberdeen, United Kingdom

  • NHS Greater Glasgow and Clyde

    NOT_YET_RECRUITING

    Glasgow, United Kingdom

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Norwich, United Kingdom

  • Nottingham University Hospitals NHS Trust

    RECRUITING

    Nottingham, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Oxford, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Sheffield, United Kingdom

  • Swansea Bay University Local Health Board

    NOT_YET_RECRUITING

    Swansea, United Kingdom

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, United Kingdom

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    NOT_YET_RECRUITING

    Liverpool, United Kingdom

  • The Leeds Teaching Hospitals NHS Trust

    NOT_YET_RECRUITING

    Leeds, United Kingdom

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Newcastle, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    NOT_YET_RECRUITING

    London, United Kingdom

  • Torbay and South Devon NHS Foundation Trust

    NOT_YET_RECRUITING

    Torquay, United Kingdom

  • University College London Hospital NHS Foundation Trust

    NOT_YET_RECRUITING

    London, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    NOT_YET_RECRUITING

    Southampton, United Kingdom

  • University Hospital of North Midlands NHS Trust

    NOT_YET_RECRUITING

    Stoke-on-Trent, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • University Hospitals Coventry and Warwickshire NHS Trust

    NOT_YET_RECRUITING

    Coventry, United Kingdom

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