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Recruiting NCT06526065

Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)

— Observational DLBCL - Diffuse Large B Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no intervention.
Who it may be relevant to
Registry conditions: DLBCL - Diffuse Large B Cell Lymphoma. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Molecular Mechanisms in Malignant Lymphoma- Predict

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.

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

  • Other no intervention
    no intervention

Primary outcome measures

  • Progression-free Survival (PFS-2) with 95% confidence intervals [Time frame: 2 years]
Secondary outcome measures (4)
  • Overall Survival (OS) [Time frame: 5 years]
  • Event-free survival (EFS) [Time frame: 5 years]
  • Response rates [Time frame: 2 years]
  • Safety and toxicity [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Histological diagnosis of DLBCL\&LBCL
  • Planned treatment with guideline-based first-line therapy
  • Patient's consent
  • All genders, Patient age ≥ 18 years
  • Ability to consent

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Universitätsmedizin Göttingen — Göttingen

Identifiers

NCT: NCT06526065 · 4/3/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗