Lymphoma, B Cell
Conditions
Brief summary
The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy
Interventions
Sponsors
International Extranodal Lymphoma Study Group (IELSG)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 informed consent 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informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice
Exclusion criteria
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 skin cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
| Progression-free survival | — |
| Event-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival will be a secondary end-point because post-relapse therapy is not specified in this protocol and is expected to be highly variable | — |
Countries
Switzerland
Outcome results
None listed