Real-world data and samples from frail or multiply treated large B‑cell lymphoma patients
Official title: A reaL-world Data and Sample coMpendium of frAil aNd/or Multiply treAted Patients With Large B-Cell Lymphoma
Run by The Clatterbridge Cancer Centre NHS Foundation Trust · NCT07335120 · Data updated 2026-11-12
This project collects health records and blood and tissue samples from older, frail, or multiply treated people with diffuse large B‑cell lymphoma to see which treatments they receive and how they fare.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 17 Years and up |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | The Clatterbridge Cancer Centre NHS Foundation Trust Academic / other |
| Drugs / interventions | CAR-T, immunotherapy, chemotherapy |
| Locations | 1 site (Liverpool, Merseyside) |
| Status | Recruiting |
| Started | October 30, 2024 |
| Main results expected | October 30, 2026 |
| Study ends | October 30, 2028 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT07335120 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 16 or older with histologically confirmed large B‑cell lymphoma, particularly those who are elderly, frail, or have had multiple prior treatments and who can provide informed consent.
✕Probably not a fit
Patients who are fit for standard full‑dose R‑CHOP or Pola‑R‑CHP and who are not receiving reduced‑dose or alternative regimens are unlikely to gain direct benefit from this observational project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
ALMANAC is an observational compendium that will gather real-world clinical data and biological samples from patients with large B‑cell lymphoma, with emphasis on those who are frail, elderly, or have received multiple prior treatments. Participants are adolescents and adults aged 16 and above with histologically confirmed LBCL who can give informed consent. Collected information will include treatment regimens (including reduced‑dose and alternative chemo‑immunotherapy), outcomes, and adverse events, alongside stored blood and tissue samples for translational research. The project is based at The Clatterbridge Cancer Centre and uses routine-care data rather than testing investigational therapies.
Why it matters
Potential benefit: If successful, the compendium could help identify which lower‑intensity or alternative treatments work best for frail or multiply treated LBCL patients and inform better treatment choices.
How similar studies have gone: Similar real‑world data collections and biorepositories in lymphoma have yielded useful insights into practice and outcomes, but a dedicated compendium focused on frail or multiply treated LBCL is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and female subjects ≥16 years of age at the time of enrolment. * Ability to understand and sign written informed consent. * Previously untreated histologically proven Large B-cell non-Hodgkin's lymphoma (LBCL) according to the current World Health Organisation 2016 classification including all morphological variants. Cohort A: * Large B-cell lymphomas i) Diffuse large B-cell lymphoma, NOS ii) T-cell/histiocyte-rich large B-cell lymphoma iii) Diffuse large B-cell lymphoma/ high grade B-cell lymphoma with MYC and BCL2 re-arrangements. iv) High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements v) ALK-positive large B-cell lymphoma vi) Large B-cell lymphoma with IRF4 rearrangement vii) High-grade B-cell lymphoma with 11q aberrations or Burkitt-like lymphoma with 11q aberration viii) EBV-positive diffuse large B-cell lymphoma EBV-positive diffuse large B-cell lymphoma, NOS ix) Diffuse large B-cell lymphoma associated with chronic inflammation x) Fibrin-associated large B-cell lymphoma xi) Plasmablastic lymphoma xii) Primary large B-cell lymphoma of immune-privileged sites (vitro-retinal and testis but not CNS) and Intravascular large B-cell lymphoma xiii) Primary mediastinal large B-cell lymphoma xiv) Mediastinal grey zone lymphoma B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classic Hodgkin lymphoma xv) High-grade B-cell lymphoma, NOS xvi) HIV or KSHV/HHV8-positive diffuse large B-cell lymphoma * De novo presentations of transformed indolent B-cell lymphomas. * LBCL patients with de novo disease unfit for full dose R-CHOP/Pola-R-CHP OR Cohort B: * LBCL patients (as in Cohort A) with relapsed/refractory disease (including de novo transformed indolent B-cell lymphomas) following frontline (one previous line of chemo-immunotherapy) including any line CAR-T therapy. * Patients fulfilling the above criteria who are on other trials/studies are eligible for recruitment. * Patients previously registered into Cohort A with subsequent relapsed/refractory disease. Such patients can be registered into cohort B and will be given a new study number that is linked to their study number for cohort A. * Data for patients commencing treatment \<6 months prior to enrolment and with ongoing follow-up can be entered retrospectively. Exclusion Criteria: 1. Patients treated \>6 months prior to trial enrolment (Cohort B). 2. Patients eligible for full dose R-CHOP/Pola-R-CHP (Cohort A) 3. Patients with CNS lymphoma 4. Lymphoid proliferations and lymphomas associated with immune suppression and dysregulation. (e.g., Post-Transplant Lymphoproliferative Disorders)
Where it's running
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The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, Merseyside, United Kingdom Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.