Cancer

Title
Treatment of Subjects With Limited (Early) Stage Diffuse Large B-Cell Lymphoma (DLBCL) Using PET/CT Scans
Trial Number
204177041812
Number of Participants
155
Principal Investigator

Scott Smith

M.D.,Ph.D., FACP
Hematology/Oncology
Associate Professor
Category
Lymphoma
Eligibility

Participants must have biopsy-proven Diffuse Large B-cell Lymphoma.
Participants must have non-bulky Stage I or II disease by Ann Arbor classification. This staging excludes FDG-PET evaluation. Participants who have Stage I or II non-bulky disease based on diagnostic CT scan, but are upstaged to Stage III or IV based on FDG-PET evaluation are also eligible.
Participants must have a diagnostic quality contrast-enhanced CT scan of the chest, abdomen and pelvis, and baseline FDG-PET scan performed within 28 days prior to registration. Low resolution "localization" CT scans performed as part of a combined PET/CT scan are not adequate for enrollment or response determination on this protocol. If the participant has an allergy to CT contrast, then a non-enhanced CT will be acceptable.
Participants must not have clinical evidence of central nervous system involvement by lymphoma. Participants with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed with 42 days prior to registration.
Participants must have a unilateral or bilateral bone marrow biopsy performed within 42 days prior to registration. The lymphoma must express the CD20.
Participants must not have received prior chemotherapy, radiation, or antibody therapy for lymphoma.
Participants must have a Zubrod performance status of 0 to 2.

Purpose

Limited (or early) Stage Diffuse Large B-cell Lymphoma is curable in many people, but some still relapse, and some develop side- effects after this treatment. This study uses a radiologic test called PET/CT scan to determine further treatment after initial doses of a standard chemotherapy called "R-CHOP" (the drugs doxorubicin, cyclophosphamide, vincristine, prednisone and rituximab). Although all of the agents used in this study are FDA approved, the purpose of the study is to give more intensive treatment to participants whose PET/CT scan shows that they are at a greater risk of still having active lymphoma, and to give less intensive treatment to participants whose PET/CT scan shows that they have a smaller risk of still having active lymphoma. In this way, we hope to improve the cure rate for all patients while decreasing the side effects of the treatment.

Enrollment

(708) 327-3228

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