Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)

NCT06526065 | Recruiting

• 1 other identifier: 4/3/24
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

DLBCL - Diffuse Large B Cell Lymphoma

Outcome Measures

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.

  2 years

Secondary Outcomes (4)

• Overall Survival (OS)

  5 years

• Event-free survival (EFS)

  5 years

• Response rates

  2 years

• Safety and toxicity

  5 years

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with initial diagnosis of DLBCL qualified for a treatment with R-CHOP/ R-CHOP-like regime

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Center Goettingen: lead
• 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

Study Sites (1)

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Leucocytes Liquid Biopsy Tumor paraffin embedded biopsy

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lorenz Trümper

  PI of the study

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna-Carina Hund

CONTACT

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

Gerald Wulf

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Lorenz Trümper

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)