Diffuse Large B-cell LymphomaNCT01865058
The Use of PET for the Early Response Evaluation in Patients With Diffuse Large B-cell Lymphoma.
An observational study of Diffuse Large B-cell Lymphoma, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark accounts for almost 40% of newly diagnosed NHL cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosis of Diffuse Large B-cell lymphoma
Who may be able to join
- -Age>18 years
Who cannot join
- Previously treatment with chemotherapy or irradiation
- Primary CNS lymphoma
- Recurrent lymphoma
- Transformation from indolent lymphoma
- Presence of diabetes mellitus, HIV, chronic inflammatory disease or infections
- Planned for curative treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hematology Rearch Unit, Odense University Hospital
Odense, Fyn, 500
Karen Juul Mylam, MD, karen.mylam@rsyd.dk
Karen Juul Mylam, MD
About this study
Official title: The Use of 18 F-FDG Positron Emission Tomography (PET) in the Early Response Evaluation of Diffuse Large B-cell Lymphoma.
Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark accounts for almost 40% of newly diagnosed NHL cases. Treatment with the combination of chemotherapy and monoclonal antibodies has significantly improved prognosis over the past decade, but a large proportion of patients with DLBCL will continue to relapse with our current treatment options. Therefore, there is a need for reliable methods for detection of treatment response as early as possible in the treatment course in order to identify patients who respond poorly to standard treatment and potentially would benefit from a change in treatment strategy. This has still not been established, but a valid early marker is required in order to allow randomized trials of treatment stratified by early response. One of the most promising applications of PET is the metabolic assessment of the early response of cancer treatment.
This study is a national prospective multicenter study emanating from the Danish Lymphoma Group (DLG). Patients are scanned after each of the early 4 cycles of chemo therapy. The aim is to establish the correct timing of response evaluation. Additionally, the investigators wish to investigate the optimal qualitative and quantitative method of response assessment in order to predict post-therapeutic remission and long-term prognosis.This study will contribute to interim-PET being implemented in the most optimal way in daily clinical practice.
- Conditions
- Diffuse Large B-cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DLBCL | Patients with newly diagnosis of diffuse large B-cell lymphoma is offered enrollment in this protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 2 years
Progression free survival
Measured: 3 years
Secondary outcomes (1)
Overall survival
Measured: 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startJun 2011
- Primary completionFeb 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Karen Juul Mylam, Odense University Hospital
- Investigators
- Karen Juul Mylam, MD, Principal investigator, Hematology research Unit, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865058
- Sponsor's protocol ID
- DLG-PET 10.06
- Status last verified
- May 2013
- First submitted
- 1 May 2013
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of 18 F-FDG Positron Emission Tomography (PET) in the Early Response Evaluation of Diffuse Large B-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT01865058
- Acronym / sponsor ID
- DLG-PET 10.06
- Conditions
- Diffuse Large B-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Jun 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 30 May 2013 (estimated)
- 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.
Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark accounts for almost 40% of newly diagnosed NHL cases. Treatment with the combination of chemotherapy and monoclonal antibodies has significantly improved prognosis over the past decade, but a large proportion of patients with DLBCL will continue to relapse with our current treatment options. Therefore, there is a need for reliable methods for detection of treatment response as early as possible in the treatment course in order to identify patients who respond poorly to standard treatment and potentially would benefit from a change in treatment strategy. This has still not been established, but a valid early marker is required in order to allow randomized trials of treatment stratified by early response. One of the most promising applications of PET is the metabolic assessment of the early response of cancer treatment.
This study is a national prospective multicenter study emanating from the Danish Lymphoma Group (DLG). Patients are scanned after each of the early 4 cycles of chemo therapy. The aim is to establish the correct timing of response evaluation. Additionally, the investigators wish to investigate the optimal qualitative and quantitative method of response assessment in order to predict post-therapeutic remission and long-term prognosis.This study will contribute to interim-PET being implemented in the most optimal way in daily clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DLBCL | – | –Patients with newly diagnosis of diffuse large B-cell lymphoma is offered enrollment in this protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosis of Diffuse Large B-cell lymphoma
Key inclusion criteria (1 listed)
- -Age>18 years
Key exclusion criteria (6 listed)
- Previously treatment with chemotherapy or irradiation
- Primary CNS lymphoma
- Recurrent lymphoma
- Transformation from indolent lymphoma
- Presence of diabetes mellitus, HIV, chronic inflammatory disease or infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival
Time frame: 2 years
Progression free survival
Time frame: 3 years
1 secondary outcome
Overall survival
Time frame: 2 years, 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
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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. This study is not recruiting at the moment.
Karen Juul Mylam, MD principal investigator
Hematology research Unit, Odense University Hospital
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 Diffuse Large B-cell Lymphoma, run by Odense University Hospital at 1 site in Denmark.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 May 2013. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Juul Mylam, MD (0045 6541 1637, karen.mylam@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 2 years). The study lists 2 primary outcomes in all. 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 30 May 2013.