Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 337564 | Other Identifier | IRAS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| 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 |
Not provided
Not provided
Inclusion Criteria:
Cohort A:
Cohort B:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Clatterbridge Cancer Centre NHS Foundation Trust | Recruiting | Liverpool | Merseyside | L78YA | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Blood, PBMCs, tissue