DLBCL - Diffuse Large B Cell LymphomaNCT06526065
Molecular Mechanisms in Malignant Lymphoma- Predict (MMML Predict)
An observational study of DLBCL - Diffuse Large B Cell Lymphoma, run by University Medical Center Goettingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jun 2024to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with initial diagnosis of DLBCL qualified for a treatment with R-CHOP/ R-CHOP-like regime
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075
Anna-Carina Hund
About this study
Official title: 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.
Read the 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.
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Being tested
- no intervention
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 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
Measured: 5 years
Response rates
overall response to treatment
Measured: 2 years
Safety and toxicity
treatment side effects
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start20 Jun 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Wuerzburg University Hospital, University Hospital Ulm, University of Leipzig, University Hospital Regensburg, University Hospital Freiburg, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), University of Kiel, University Hospital, Essen
- Responsible party
- Principal investigator, Trümper, University Medical Center Goettingen
- Investigators
- Lorenz Trümper, Principal investigator, PI of the study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526065
- Sponsor's protocol ID
- 4/3/24
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms in Malignant Lymphoma- Predict
- ClinicalTrials.gov ID
- NCT06526065
- Acronym / sponsor ID
- 4/3/24
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Wuerzburg University Hospital, University Hospital Ulm, University of Leipzig, University Hospital Regensburg, University Hospital Freiburg, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), University of Kiel, University Hospital, Essen
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with initial diagnosis of DLBCL qualified for a treatment with R-CHOP/ R-CHOP-like regime
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenz Trümper principal investigator
PI of the study
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DLBCL - Diffuse Large B Cell Lymphoma, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna-Carina Hund (+495513961041, anna-carina.hund@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS-2) with 95% confidence intervals (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.