A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin's Lymphoma
1. age = 18 years.
2. ECOG performance status 0-2
3. Histologically proven primary testicular CD20-positive diffuse large B-cell
non-Hodgkin's lymphoma, untreated
4. Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not
be considered stage IV. In these patients the final Ann Arbor stage will be
determined by the extent of nodal involvement.
5. Bidimensionally measurable or evaluable disease. Patients who have had all disease
removed by surgery are eligible.
6. Adequate bone marrow reserve (ANC > 1.000/L, Plt > 100.000/L)
7. Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
8. No previous therapy with monoclonal antibody anti-CD20.
9. No psychiatric illness that precludes understanding concepts of the trial or signing
10. No other major life-threatening illnesses that may preclude chemotherapy
11. Have given written informed consent prior to any program-specific screening
procedure, with the understanding that the consent may be withdrawn by the patient at
any time without prejudice
1. impairment of renal function (creatinine > 2 mg/dl) or liver function (bilirubin > 2
mg/dl) unless due to lymphoma involvement
2. HIV positive patients
3. evolutive malignancy within 5 years with the exception of localized non-melanomatous