Conditions: Lymphoma
Keywords: recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage I adult diffuse large cell lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 57
Healthy volunteers: no

Brief summary:
The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.

Detailed description:
In this phase II multi-institutional trial, the investigators will identify genes associated with either good or bad outcome in DLBCL patients treated with R-CHOP, will construct a robust predictive models based on RNA extracted from or paraffin specimens as well on immunohistochemistry and will examine the predictive power of new biomarkers associated with the anti-tumor effects of rituximab. The acquisition of fixed tissue as a component of this uniformly treated prospective study will also afford future studies with this informative dataset.

Arms:
arm 1: Patients will receive R-CHOP for 6 to 8 cycles:

* Rituximab 375 mg/m2 on day 1
* Cyclophosphamide 750 mg/m2 IV on day 1
* Doxorubicin 50 mg/m2 on day 1
* Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
* Prednisone 100 mg orally days 1-5, repeated every 21 days.

Interventions: intervention 1: Rituximab intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Prednisone intervention 5: Vincristine
Intervention descriptions: intervention 1: Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles intervention 2: Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles intervention 3: Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles intervention 4: Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles. intervention 5: Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles

Protocol document: