Diffuse large B-cell lymphoma Cancer Diffuse large B-cell lymphoma
Conditions
Interventions
APOLLO+ is designed to collect prospective demographic and clinical data from patients with DLBCL falling into one of two cohorts:
1. Patients ineligible for first-line treatment with R-CHOP (a maximu
Sponsors
Clatterbridge Cancer Centre NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and female subjects =16 years of age at the time of enrolment 2. Ability to understand and sign written informed consent 3. Histologically proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL) according to current World Health Organisation 2016 guidelines that fall into one of two cohorts that will be independently evaluated/reported: 3.1. DLBCL patients with de novo disease unfit for full dose R-CHOP OR 3.2. DLBCL patients with relapsed/refractory disease 4. Patients fulfilling the above criteria who are on other trials/studies are eligible for recruitment
Exclusion criteria
Exclusion criteria: Patients commencing index treatments >6 months prior to trial enrolment (Cohorts A or B). In other words, patients can be retrospectively entered (for Cohorts A or B). This exclusion does not apply to prior therapies before the index treatment event for Cohort B.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 12 months (PFS12), 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 (from the date of cohort assignment) as assessed by the investigator using the revised Lugano response criteria for malignant lymphoma (2016) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to next treatment measured as days from the start date of initial treatment to the start day of the next treatment 2. Demographic and clinical characteristics (e.g. age, sex, ethnicity, duration of disease, comorbidities, disease activity/severity, blood results) collected at baseline 3. Investigator-assessed Interim (post-cycle 4) and end of treatment responses as assessed by the investigator using the revised Lugano response criteria for malignant lymphoma (2016) 4. Overall survival (OS) measured as the time from recruitment until death by any cause 5. Relapses following treatment as assessed by the investigator using the revised Lugano response criteria for malignant lymphoma (2016) every 6 months after the end of treatment 6. Treatment pathways, including chemo-immunotherapy, concomitant treatments (including radiotherapy) and salvage therapy, recorded at treatment start and during treatment (cycles 1 to 8) 7. Quality of life measured using the EQ-5D-5L patient-completed questionnaire at baseline and end of treatment 8. Co-morbidity/frailty assessments using echocardiography or nuclear medicine examination (MUGA) pre- and post-treatment | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed