A phase II study of R-CHOP with intensive CNS prophylaxis and scrotal irradiation in patients with primary testicular diffuse large B-cell lymphoma - IELSG30

• Conditions: primary testicular lymphoma diffuse large B-cell; MedDRA version: 9.1Level: HLTClassification code 10003900

• Registration Number: EUCTR2009-011789-26-IT
• Lead Sponsor: IELSG-International Extranodal Lymphoma Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-10
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

1.Patients with primary testicular lymphoma at diagnosis.Histological subtype included into the study is only Diffuse Large B Cell Lymphoma (Attachment 2: WHO classification of lymphoma). 2. Orchiectomy is mandatory, before enrolment of the patient into the study. 3. Orchiectomy should be performed within 2 months before study entry. 4. Age 18-80 5. Untreated patients 6. Ann Arbor Stage IE and IIE. Bilateral testicular involvement at presentation will not be considered Stage IV. These patients may be included into the study and the final Ann Arbor stage (I or II) will be determined by the extent of nodal disease. 7. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible. 8. Adequate haematological counts: ANC > 1.0 x 109/L and PLTs count > 75 x 109/L 9. Cardiac ejection fraction `` 45% by MUGA scan or echocardiography 10. Non peripheral neuropathy or any active non-neoplastic CNS disease. 11. No other major life-threatening illnesses that may preclude chemotherapy 12. Conjugated bilirubin ! 2 x ULN. 13. Alkaline phosphatase and transaminases ! 2 x ULN. 14. Creatinine clearances `` 45 ml/min. 15. HIV negativity 16. HBV negativity or patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative 17. HCV negativity with the exception of patients with no signs of active chronic hepatitis histologically confirmed 18. Life expectancy > 6 months. 19. Performance status < 2 according to ECOG scale. 20. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent 21. Written informed Consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
1.Patients with primary testicular lymphoma at diagnosis.Histological subtype included into the study is only Diffuse Large B Cell Lymphoma (Attachment 2: WHO classification of lymphoma). 2. Orchiectomy is mandatory, before enrolment of the patient into the study. 3. Orchiectomy should be performed within 2 months before study entry. 4. Age 18-80 5. Untreated patients 6. Ann Arbor Stage IE and IIE. Bilateral testicular involvement at presentation will not be considered Stage IV. These patients may be included into the study and the final Ann Arbor stage (I or II) will be determined by the extent of nodal disease. 7. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible. 8. Adequate haematological counts: ANC > 1.0 x 109/L and PLTs count > 75 x 109/L 9. Cardiac ejection fraction `` 45% by MUGA scan or echocardiography 10. Non peripheral neuropathy or any active non-neoplastic CNS disease. 11. No other major life-threatening illnesses that may preclude chemotherapy 12. Conjugated bilirubin ! 2 x ULN. 13. Alkaline phosphatase and transaminases ! 2 x ULN. 14. Creatinine clearances `` 45 ml/min. 15. HIV negativity 16. HBV negativity or patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative 17. HCV negativity with the exception of patients with no signs of active chronic hepatitis histologically confirmed 18. Life expectancy > 6 months. 19. Performance status < 2 according to ECOG scale. 20. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent 21. Written informed Consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Has known or suspected hypersensitivity or intolerance to rituximab 2. History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances 3. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug) 4. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 5. History of clinically relevant hypotension CNS involvement (meningeal and/or brain involvement by lymphoma) 7. Evolving malignancy within 3 years with the exception of localized non-melanomatous skin cancer 8. HIV positivity 9. HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative 10. HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed 11. Active opportunistic infection 12. Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy 13. Exposure to Rituximab prior study entry 14. Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. 15. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
;
1.Has known or suspected hypersensitivity or intolerance to rituximab 2. History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances 3. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug) 4. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 5. History of clinically relevant hypotension CNS involvement (meningeal and/or brain involvement by lymphoma) 7. Evolving malignancy within 3 years with the exception of localized non-melanomatous skin cancer 8. HIV positivity 9. HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative 10. HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed 11. Active opportunistic infection 12. Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy 13. Exposure to Rituximab prior study entry 14. Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. 15. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified