The Use of PET for the Early Response Evaluation in Patients With Diffuse Large B-cell Lymphoma.

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

The Use of 18 F-FDG Positron Emission Tomography (PET) in the Early Response Evaluation of Diffuse Large B-cell Lymphoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01865058
• Other study ID #: DLG-PET 10.06
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2013
• Last updated: May 26, 2013
• Start date: June 2011
• Est. completion date: August 2014

Study information

• Verified date: May 2013
• Source: Odense University Hospital
• Contact: Karen Juul Mylam, MD
• Phone: 0045 6541 1637
• Email: karen.mylam[@]rsyd.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommiteeDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Age>18 years

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Locations

Country	Name	City	State
Denmark	Hematology Rearch Unit, Odense University Hospital	Odense	Fyn

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment response (CR, PR, PD)	The time frame is from baseline PET scanning to completions of therapy.	Up to 24 weeks	No
Primary	Progression free survival		2 years	No
Primary	Progression free survival		3 years	No
Secondary	Overall survival		2 years, 3 years	No