DLBCL - Diffuse Large B Cell Lymphoma
Conditions
Brief summary
The trial aims at the construction and validation of an accurate, affordable and simple prognostic tool to be used in everyday clinical practice, which allows the early and reliable identification of DLBCL patients who have a very high risk of treatment failure following R-CHOP/-like first-line therapy.
Detailed description
Observational study of 500 recruited and 300 evaluable patients with de novo large cell B Cell lymphoma, age 18-80. Standard guideline recommended treatment by treating physicians discretion. Collection of clinical data, PET-CT data, liquid biopsy, WGSequencing to determine optimal prognostic factors to surpass prediction offered by current IPI.
Interventions
OTHERno intervention
no intervention
Sponsors
Charite University, Berlin, Germany
Wuerzburg University Hospital
University Hospital Ulm
University of Leipzig
University Hospital Regensburg
University Hospital Freiburg
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
University of Kiel
University Hospital, Essen
University Medical Center Goettingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Histological diagnosis of DLBCL&LBCL 2. Planned treatment with guideline-based first-line therapy 3. Patient's consent 4. All genders, Patient age ≥ 18 years 5. Ability to consent
Exclusion criteria
1. Treatment with R-CHOP/-like regimens already started 2. Relationship of dependence/ direct employment with the investigator 3. Active HIV-infection 4. Presence history of other active cancers (with the exception of basal cell carcinoma of the skin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS-2) with 95% confidence intervals | 2 years | PFS is defined as the time from the day of inclusion into the observation trial through one of the following events, whichever comes first: * Change of treatment due to response in iPET (PD - Progressive Disease) * Disease progression * Relapse * Death due to any cause Patients without event at the time of analysis will be censored at the most recent date of disease assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 5 years | Overall Survival (OS) is defined as the time from the day of inclusion into the observation trial to death due to any cause; patients without event will be censored at the last date known to be alive. |
| Event-free survival (EFS) | 5 years | Event-free survival (EFS) is defined as the time from the day of inclusion into the observation trial through one of the following events, whichever comes first: * Change of treatment due to response in iPET (PD) * Disease progression * Start of additional, unplanned anti-lymphoma therapy (consolidation radiotherapy as per S3LL excluded) * Relapse * Death due to any cause |
| Response rates | 2 years | overall response to treatment |
| Safety and toxicity | 5 years | treatment side effects |
Countries
Germany
Contacts
Primary ContactAnna-Carina Hund
Backup ContactGerald Wulf
Outcome results
None listed