Safety and Feasibility Study of Combination of State of Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Diffuse Large B-cell Lymphoma of Testis (IELSG30)

International Extranodal Lymphoma Study Group (IELSG)

Status and phase: Completed; Phase 2

Conditions: Large B-cell Diffuse Lymphoma of Testis

Treatments: Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT00945724

EudraCT Number 2009-011789-26

IELSG30

Details and patient eligibility

About

This trial is a phase II non-comparative study aimed to determine the feasibility and toxicity of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and systemic intermediate-dose methotrexate followed by loco-regional radiotherapy.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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
6. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

R-CHOP, Depocyte, Methotrexate

Experimental group

Treatment:

Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate