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A Real-world Data and Sample Compendium of Frail and/or Multiply Treated Large B-cell Lymphoma

Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust

NCT ID: NCT07335120

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 48 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
17 Years and over
Who
All
Number of participants
800
Started
2024-10-30
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for dlbcl
  • • Clinical study - 800 participants
  • • LBCL is a cancer of the lymphatic system where B-cells (a type of white blood cell) experience uncontrolled growth

Who can take part?

  • • Ages 17 Years and over
  • • Diagnosed with dlbcl

Where?

  • • Liverpool - The Clatterbridge Cancer Centre NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

LBCL is a cancer of the lymphatic system where B-cells (a type of white blood cell) experience uncontrolled growth. The standard treatment for LBCL is a combination of chemotherapy and immunotherapy, referred to as chemo-immunotherapy. Currently, the best results in the treatment of LBCL is with a chemo-immunotherapy combination called R-CHOP or Pola-R-CHP. Full doses of treatment are not suitable for elderly or frail patients due to potential to cause side effects and heart problems. Such patients either receive a reduced dose called mini-R-CHOP or receive alternatives (e.g. R-GCVP or R-CEOP). Additionally, some patients treated with R-CHOP or Pola-R-CHP may not respond or may respond initially before relapsing. For these patients, treatment is not standardised, and practice varies between hospitals. ALMANAC aims to collect data about the management and outcomes of patients with LBCL who are unsuitable for standard treatments because they are not well enough to tolerate the side effects or because they have not responded or relapsed following initial treatment. In doing so, it will guide research into LBCL leading to a better understanding of this condition and better outcomes.

DLBCL

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 17 Years and over
  • Who can join: All genders

Biomarkers mentioned

ALK

Treatment history

Treatments you must have had:

  • ✓ of chemo-immunotherapy) including any line CAR-T therapy

What the study is looking for

  • ✓Males and female subjects ≥16 years of age at the time of enrolment.
  • ✓Ability to understand and sign written agreement to take part.
  • ✓Previously untreated histologically proven Large B-cell non-Hodgkin's lymphoma (LBCL) according to the current World...
  • ✓Cohort A:
  • ✓De novo presentations of transformed indolent B-cell lymphomas.

Who cannot take part

  • ✗Patients treated \>6 months prior to trial enrolment (Cohort B).
  • ✗Patients eligible for full dose R-CHOP/Pola-R-CHP (Cohort A)
  • ✗Patients with CNS lymphoma
  • ✗Lymphoid proliferations and lymphomas associated with immune suppression and dysregulation. (e.g., Post-Transplant...
See the full 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 Is This Study? (1 UK site)

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool L78YA, United Kingdom

Recruiting
Site contact (verified)
Vikram Singh, MDPrincipal Investigator
Data sourced from ClinicalTrials.gov · Last verified: 2026-01