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NCT Number: NCT06526065

Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)

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.

Recruiting

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Key information

Conditions

DLBCL - Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location status: Recruiting

Location contact

Anna-Carina Hund

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Progression-free Survival (PFS-2) with 95% confidence intervals

    Time frame: 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 outcomes

  1. Overall Survival (OS)

    Time frame: 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.

  2. Event-free survival (EFS)

    Time frame: 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

  3. Response rates

    Time frame: 2 years

    overall response to treatment

  4. Safety and toxicity

    Time frame: 5 years

    treatment side effects

Study contacts

Contact information is provided by the study sponsor or research team.

Anna-Carina Hund

CONTACT

[email protected]

+495513961041

Gerald Wulf

CONTACT

[email protected]

+495513962050

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Collaborators

  • Charite University, Berlin, Germany
  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
  • University Hospital Freiburg
  • University Hospital Regensburg
  • University Hospital Ulm
  • University Hospital, Essen
  • University of Kiel
  • University of Leipzig
  • Wuerzburg University Hospital

Registry information

Official study title

Molecular Mechanisms in Malignant Lymphoma- Predict

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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