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)
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|ClinicalTrials.gov Identifier: NCT00945724|
Recruitment Status : Active, not recruiting
First Posted : July 24, 2009
Last Update Posted : March 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Large B-cell Diffuse Lymphoma of Testis||Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of R-CHOP With Intensive CNS Prophylaxis and Scrotal Irradiation in Patients With Primary Testicular Diffuse Large B-cell Lymphoma|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2023|
|Experimental: R-CHOP, Depocyte, Methotrexate||
Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate
• Methotrexate 1.5 g/m2 q14 Days x 2
From Week 24:
• Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease)
- Adverse events assessments [ Time Frame: throughout the active treatment period until 30 days after the last drug administration ]
- Activity of the drugs [ Time Frame: After the 3rd course (and before the 4th) of R-CHOP. Clinical response will be re-assessed at the end of planned treatment, one-two month after the completion of the whole therapy, including radiotherapy In the follow up period every 6 months ]
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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).
- Orchiectomy is mandatory, before enrolment of the patient into the study.
- Orchiectomy should be performed within 2 months before study entry.
- Age 18-80
- Untreated patients
- 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.
- Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
- Adequate haematological counts: ANC > 1.0 x 109/L and PLTs count > 75 x 109/L
- Cardiac ejection fraction ≥ 45% by MUGA scan or echocardiography
- Non peripheral neuropathy or any active non-neoplastic CNS disease.
- No other major life-threatening illnesses that may preclude chemotherapy
- Conjugated bilirubin ≤ 2 x ULN.
- Alkaline phosphatase and transaminases ≤ 2 x ULN.
- Creatinine clearances ≥ 45 ml/min.
- HIV negativity
- HBV negativity or patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
- HCV negativity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
- Life expectancy > 6 months.
- Performance status < 2 according to ECOG scale.
- No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
- Written informed Consent
- Has known or suspected hypersensitivity or intolerance to rituximab
- History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
- 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
- History of clinically relevant hypotension
- CNS involvement (meningeal and/or brain involvement by lymphoma)
- Evolving malignancy within 3 years with the exception of localized non-melanomatous skin cancer
- HIV positivity
- HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
- HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
- Active opportunistic infection
- Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy
- Exposure to Rituximab prior study entry
- 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.
- Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945724
|Study Chair:||Emanuele Zucca, MD||IOSI|
|Responsible Party:||International Extranodal Lymphoma Study Group (IELSG)|
|Other Study ID Numbers:||
EudraCT Number 2009-011789-26
|First Posted:||July 24, 2009 Key Record Dates|
|Last Update Posted:||March 10, 2023|
|Last Verified:||March 2023|
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Topoisomerase II Inhibitors