| Inclusion Criteria: | 1) Patients must have reached their 60th birthday by the time of enrollment. Patients age 60-65 must be deemed ASCT ineligible at the time of enrollment.
2) Patients must have an initial diagnosis of diffuse large B-cell lymphoma that is confirmed by one of the hematopathologists at the treating institution. Any of the following subtypes of DLBCL, WHO Classification are eligible: centroblastic, immunoblastic, T-cell/histiocyte-rich, lymphomatoid granulomatosis type, anaplastic large B-cell, plasmablastic, mediastinal, or intravascular large B-cell lymphoma. Lymphomas with discordant histology (small cells in the bone marrow) and a DLBCL diagnosis will be eligible for enrollment. All must have initial diagnostic specimen that is CD20-positive.
3) Patients must have at least Ann Arbor Stage II disease and not have disease confined to an involved field radiation port.
4) Patients must have high-intermediate or high-risk DLBCL as defined by an Age-Adjusted IPI (aaIPI) score of 2 or 3 (with 1 point each assigned for a ECOG>1 / KPS less than or equal to 70%, LDH>1x normal, and Stage III or IV)
5) Patients must not have received prior chemotherapy, biologic therapy, or radiation therapy. Patients who have received steroids for less than or equal to 14 consecutive days are eligible. Patients with a history of prior intravenous contrast allergy are permitted to receive steroids as a premedication. However, patients who have already received a single cycle of R-CHOP at standard dosages and otherwise meet all eligibility requirements will be allowed enrollment. These patients will start therapy with cycle number two of R-CHOP provided all pretreatment evaluations meet protocol criteria.
6) Karnofsky performance status of at least 50%.
7) Patients must have a total bilirubin of 2.0 mg/dL or less at the time of study enrollment. The patient may have a bilirubin >2.0 mg/dL if he/she has a history of Gilbert's disease.
8) Patients must have adequate renal function defined as a serum creatinine of 1.5 mg/dL or less at the time of study enrollment. Patients with a serum creatinine of 1.6 mg/dL or greater are still eligible if their 12 or 24-hour creatinine clearance is measured at >50 mL/min. Patients who do not meet either criteria but have renal insufficiency that is believed to be directly caused by lymphomatous involvement of the kidneys or renal collecting system are eligible.
9) Patients must have a cardiac ejection fraction of 50% or greater as determined by echocardiogram.
10) Patients must have HIV antibody test drawn within 4-6 weeks of enrollment; results may be pending provided there is no history of known risk factors or clinical suspicion of HIV.
11) Patients must have no concurrent uncontrolled medical problems that would preclude administration of chemotherapy or radioimmunotherapy.
12) Patients receiving therapeutic doses of Coumadin may be considered eligible for therapy. Given the potential for thrombocytopenia on this study, the patient's coagulation studies will be closely monitored.
13) Patients must have no prior history of radiotherapy or chemotherapy for a cancer diagnosis (other than lymphoma as listed above) within the last 5 years.
14) Patients must have bi-dimensionally measurable disease at the time of study entry, defined as at least one lymph node greater than or equal to 2.0 x 2.0 cm on physical examination, CT scan, or PET scan.
15) Bone Marrow cellularity at entry must be greater than 15% as determined by a treating institution's hematopathologists or specified as normocellular (~40%) or hyper cellular on the bone marrow biopsy report.
16) Patients must have no known brain or leptomeningeal metastases at the time of study enrollment.
17) Patients must be capable of providing written informed consent.
18) Patients must be screened for Hepatitis B prior to enrollment. |