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

A reaL-world Data and Sample coMpendium of frAil aNd/or Multiply treAted Patients With Large B-Cell Lymphoma

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.

Study Overview

• Status: Recruiting
• Conditions: DLBCL

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L78YA
      • Recruiting
      • The Clatterbridge Cancer Centre NHS Foundation Trust
      • Contact: Maria Maguire, PhD; Phone Number: +44 7824609720; Email: maria.maguire2@nhs.net
      • Contact: Ellen Nicholson, BSc; Phone Number: +44 7909042950; Email: ellen.nicholson5@nhs.net
      • Principal Investigator: Vikram Singh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort A; Patients with LBCL requiring treatment but considered unsuitable for standard of care (SOC) treatments (full dose R-CHOP or Pola-R-CHP).
Cohort B; Patients with relapsed/refractory LBCL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoints (Cohorts A and B)- Progression Free Survival at 12 months (PFS12):	Progression Free Survival at 12 months (PFS12): Progression-free survival defined as disease progression or recurrence, or death from any cause, (defined as days from the date of cohort assignment to event) occurring within 12 months as assessed by the investigator using the revised Lugano response criteria for malignant lymphoma (2016).	12 Month

Collaborators and Investigators

• Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: C1469A; 337564 (Other Identifier: IRAS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No