Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity Medical Center Goettingen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological diagnosis of DLBCL&LBCL
Planned treatment with guideline-based first-line therapy
Patient's consent
All genders, Patient age ≥ 18 years
Disqualifiers
Treatment with R-CHOP/-like regimens already started
Relationship of dependence/ direct employment with the investigator
Active HIV-infection
Presence history of other active cancers (with the exception of basal cell carcinoma of the skin)
Trial population
Patients with initial diagnosis of DLBCL qualified for a treatment with R-CHOP/ R-CHOP-like regime
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
no intervention
Other interventionno intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Progression-free Survival (PFS-2) with 95% confidence intervals
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.
Time frame
2 yearsSecondary outcomes
1
Overall Survival (OS)
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.
Time frame
5 years2
Event-free survival (EFS)
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
Time frame
5 years3
Response rates
overall response to treatment
Time frame
2 years4
Safety and toxicity
treatment side effects
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Medical Center Goettingen
Lead sponsor
Charite University, Berlin, Germany
Collaborator
Wuerzburg University Hospital
Collaborator
University Hospital Ulm
Collaborator
University of Leipzig
Collaborator
University Hospital Regensburg
Collaborator
University Hospital Freiburg
Collaborator
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Collaborator
University of Kiel
Collaborator
University Hospital, Essen
Collaborator
Source ClinicalTrials.gov