S1001 A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)
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 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 patients whose PET/CT scan shows that they are at a greater chance of still having active lymphoma, and to give less intensive treatment to patients whose PET/CT scan shows that they have a smaller chance 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.
*Biopsy-proven Diffuse Large B-cell Lymphoma *No neurologic involvement *Measurable disease *18 years or older *No prior therapy for lymphoma *Normal lab test results *May not be HIV-positive *May not be pregnant or nursing
Eligible subjects will receive 3 cycles of R-CHOP chemotherapy for their lymphoma. Subject will then undergo a PET scan to determine the subsequent study regimen. Subjects with a positive PET scan will receive radiation therapy followed by Zevalin(R). Subjects with a negative PET scan will receive another cycle of R-CHOP. All subjects will be followed for up to 7 years.
07/29/2014 04:02 AM