Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)

Molecular Mechanisms in Malignant Lymphoma- 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.

Study Overview

• Status: Recruiting
• Conditions: DLBCL - Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Other: no intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Anna-Carina Hund; Phone Number: +495513961041; Email: anna-carina.hund@med.uni-goettingen.de
• Study Contact Backup: Name: Gerald Wulf; Phone Number: +495513962050; Email: gerald.wulf@med.uni-goettingen.de

Study Locations

• Germany
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Recruiting
      • Universitatsmedizin Gottingen
      • Contact: Anna-Carina Hund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	5 years
Response rates	overall response to treatment	2 years
Safety and toxicity	treatment side effects	5 years

Collaborators and Investigators

• Sponsor: University Medical Center Goettingen
• Collaborators: Charite University, Berlin, Germany; University Hospital, Essen; University of Kiel; University of Leipzig; University Hospital Freiburg; Wuerzburg University Hospital; University Hospital Ulm; University Hospital Regensburg; Robert Bosch Hospital Stuttgart
• Investigators: Principal Investigator: Lorenz Trümper, PI of the study

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: 4/3/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No