Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)

Recruiting

• Conditions: DLBCL - Diffuse Large B Cell Lymphoma

• Registration Number: NCT06526065
• Lead Sponsor: University Medical Center Goettingen

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.

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 Timeline

• Study Start: 2024-06-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29
• Primary Completion: 2026-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS-2) with 95% confidence intervals	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 Outcome Measures

Name	Time	Method
Overall Survival (OS)	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.
Event-free survival (EFS)	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
Safety and toxicity	5 years	treatment side effects
Response rates	2 years	overall response to treatment

Trial Locations

Locations (1)

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Lower Saxony, Germany