Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)

University Medical Center Goettingen500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Interventions

no interventionOTHER

no intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (1)

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, Germany

RECRUITING

Outcomes

Primary Outcomes

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 years

Secondary Outcomes

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 years

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 years

Response rates

overall response to treatment

Time frame: 2 years

Safety and toxicity

treatment side effects

Time frame: 5 years

Central Contacts

Anna-Carina Hund

CONTACT

+495513961041 anna-carina.hund@med.uni-goettingen.de

Gerald Wulf

CONTACT

+495513962050 gerald.wulf@med.uni-goettingen.de

Data from ClinicalTrials.gov

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