Clinical trial NCT00809341
Conditions: Non-Hodgkin's Lymphoma
Keywords: B-Cell non-Hodgkin's Lymphoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2009-01-01; Completion date: 2014-04-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to see if a PET scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called Non-Hodgkin's Lymphoma.

The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen can cure about half of patients with lymphoma, but in many others disease relapses (comes back). Relapses are generally treated with more chemotherapy.

We believe that a PET scan (a type of imaging study that "lights up" in areas of cells with high activity such as lymphoma), may identify patients early who are at high risk of relapse.

The purpose of this research study is to find out if people whose treatment is changed early to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have longer remissions than they would if they did not receive that high dose chemotherapy.

Detailed description:
Patients will receive 3 cycles of chemotherapy prior to mid-treatment PET-CT. Rituximab-CHOP, or an equivalent regimen must be used. During the third cycle of Rituximab-CHOP chemotherapy, a PET-CT scan will be performed. The PET scan will be designated as negative or positive. Based on the results, patients will either complete standard dose therapy or receive two cycles of R-ICE followed by high dose cyclophosphamide and rituximab.

A repeat PET-CT is required between 4 to 6 weeks following treatment completion. Patients will be followed-up every 4 months for 2 years, then every 6 months for one year, then annually until 5 years.

Arms: arm 1: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a negative PET scan will complete their chemotherapy regimen as prescribed by their oncologist. arm 2: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a positive PET scan will receive two cycles of R-ICE (rituximab, ifosfamide, carboplatin, etoposide) followed by HiCy (high-dose cyclophosphamide).
Interventions: intervention 1: Rituximab intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Prednisone intervention 6: Ifosfamide intervention 7: Carboplatin intervention 8: Etoposide intervention 9: High-dose cyclophosphamide intervention 10: PET scan
Intervention descriptions: intervention 1: 375 mg/m\^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m\^2 on Days 1, 30, and 37 as part of HiCy. intervention 2: 750 mg/m\^2 on Day 1 of each cycle as part of R-CHOP. intervention 3: 50 mg/m\^2 on Day 1 of each cycle as part of R-CHOP. intervention 4: 1.4 mg/m\^2 on Day 1 of each cycle as part of R-CHOP. intervention 5: 100 mg/day on Days 1-5 of each cycle as part of R-CHOP. intervention 6: 2000 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP. intervention 7: Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function. intervention 8: 100 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP. intervention 9: 50 mg/kg/day on Days 2-5 of HiCy. intervention 10: Performed once between Days 16-20 of cycle 3 of R-CHOP.

Protocol documents: