Early Response Assessment in Diffuse Large B-Cell Lymphoma (DLCL) Patients by 18-Fluoro-2-Deoxyglycose Positron Emission Tomography (FDG-PET)

This study is currently recruiting participants.

Verified by Weill Medical College of Cornell University, September 2008

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00754117

Purpose

Newly diagnosed DLCL patients will have baselne FDG-PET as part of initial staging (PET-1). Patients will then undergo 2 cycles of chemotherapy with R/CHOP. 14 to 21 days following cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete therapy as planned. Following completion of therapy, standard response assessment will be performed, including CT scans of the chest, abdomen and pelvis and FDG-PET scan (PET-3).

Condition
Diffuse Large B-Cell Lymphoma

MedlinePlus related topics: Lymphoma Nuclear Scans

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Early Response Assessment in Patients With Diffuse Large b-Cell Lymphoma Using 18-Fluoro-2-Deoxyglycose Positron Emission Tomography (FDG-PET)

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

evaluating the predictive value of a positive PET scan early in the course of standard chemotherapy [ Time Frame: after 2 cycles of chemotherapy ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	36
Study Start Date:	May 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
All patients All patients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Newly diagnosed diffuse large b cell lymphoma patients planning to receive 6-8 cycles of R/CHOP chemotherapy.

Criteria

Inclusion Criteria:

Patients must have histologically or cytologically confirmed diagnosis of CD20+ diffuse large B cell lymphoma (LBCL) of any stage, including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic B cell lymphoma
Patients must have received no prior anti-lymphoma therapy.
Age >18 years.
Patients must have a treatment plan to include R/CHOP or R/CHOP followed by radiotherapy.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have known HIV infection.
Patients who are, in the opinion of their treating oncologist, unable to undergo R/CHOP chemotherapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754117

Contacts

Contact: Trish Glynn, RN

212-746-6738

pwg2002@med.cornell.edu

Locations

United States, New York
Weill Cornell Medical College	Recruiting
New York, New York, United States, 10021
Contact pwg2002@med.cornell.edu
Principal Investigator: Rebecca Elstrom, MD

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

Rebecca Elstrom, MD

Weill Cornell Medical College

More Information

WCMC website This link exits the ClinicalTrials.gov site

Responsible Party:	Weill Cornell Medical College ( Dr. Rebecca Elstrom )
Study ID Numbers:	0801009588
Study First Received:	September 15, 2008
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00754117
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

diffuse large b cell lymphoma
newly diagnosed

Study placed in the following topic categories:

Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders

B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009