This Trial is a Safety and Feasibility Study of Combination of State of the Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Testicular Diffuse Large B-cell Lymphoma
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Primary Testicular Diffuse Large B-cell Lymphoma |
| Intervention | Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate |
| Phase | Phase 2 |
| Sponsor | International Extranodal Lymphoma Study Group (IELSG) |
| Responsible Party | International Extranodal Lymphoma Study Group (IELSG) |
| ClinicalTrials.gov Identifier | NCT00945724 |
| First Received | July 23, 2009 |
| Last Updated | November 22, 2013 |
| Last verified | March 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 23, 2009 |
|---|---|
| Last Updated Date | November 22, 2013 |
| Start Date | April 2009 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | This Trial is a Safety and Feasibility Study of Combination of State of the Art Chemoimmunotherapy, Intensive Central Nervous System Prophylaxis and Scrotal Irradiation to Treat Primary Testicular Diffuse Large B-cell Lymphoma |
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| 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 |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Primary Testicular Diffuse Large B-cell Lymphoma |
| Intervention | Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate WEEKS 1-15 - 6 cycles of CHOP i.v. on days 1 to 5, to be repeated q 21 days cyclophosphamide 750 mg/m2 doxorubicin 50 mg/m2 vincristine 1.4 mg/m2 prednisone 40 mg/m2 Rituximab i.v. 375 mg/m2 on day 0 or day 1 Intrathecal chemotherapy: Depocyte®, 50 mg on day 0 of cycles 2, 3, 4, 5 of CHOP WEEKS 18-22 Methotrexate i.v. 1.5 g/m2 q 14 days x 2 FROM WEEKS 24 Scrotal prophylactic radiotherapy or involved field radiotherapy (but can be planned concomitantly to R-CHOP in patients with bilateral disease) |
| Study Arm (s) | Experimental: R-CHOP, Depocyte, Methotrexate |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 35 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | December 2013 |
| Eligibility Criteria | 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 |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Emanuele Zucca, MD ++41918119040 ielsg@ticino.com |
| Location Countries | Italy, Switzerland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00945724 |
|---|---|
| Other Study ID Numbers | IELSG30 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | International Extranodal Lymphoma Study Group (IELSG) |
| Study Sponsor | International Extranodal Lymphoma Study Group (IELSG) |
| Collaborators | Not Provided |
| Investigators | Study Chair: Emanuele Zucca, MD IOSI |
| Verification Date | March 2013 |
Locations[ + expand ][ + ]
| A.O. SS. Antonio e Biagio e Cesare Arrigo | Alessandria, Italy Contact: Flavia Salvi, MDNot yet recruiting |
|---|---|
| Comprensorio Sanitario di Bolzano | Bolzano, Italy Principal Investigator: Sergio Cortelazzo, MDNot yet recruiting |
| Spedali Civili | Brescia, Italy Not yet recruiting |
| S. Martino Hospital | Genova, Italy Not yet recruiting |
| A.O.Papardo | Messina, Italy Not yet recruiting |
| San Raffaele H Scientific Institute | Milan, Italy Contact: Andres Ferreri, MD | ferreri.andres@hsr.itPrincipal Investigator: Andrés JM Ferreri, MD Recruiting |
| European Institute of Oncology | Milan, Italy Principal Investigator: Giovanni Martinelli, MDRecruiting |
| Policlinico | Modena, Italy Not yet recruiting |
| A.O. San Gerardo | Monza, Italy Not yet recruiting |
| Università Federico II | Napoli, Italy Not yet recruiting |
| AOU Maggiore della Carità | Novara, Italy Recruiting |
| S. Matteo | Pavia, Italy Principal Investigator: Luca Arcaini, MDNot yet recruiting |
| Ospedale Civile | Piacenza, Italy Not yet recruiting |
| U.O. Ematologia AUSL Ravenna | Ravenna, Italy Recruiting |
| A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia | Reggio Calabria, Italy Principal Investigator: Caterina Stelitano, MDNot yet recruiting |
| Arcispedale Santa Maria Nuova | Reggio Emilia, Italy Recruiting |
| IFO Regina Elena | Roma, Italy Principal Investigator: Francesco Pisani, MDRecruiting |
| Università La Sapienza | Rome, Italy Not yet recruiting |
| Humanitas | Rozzano, Italy Contact: Monica BalzarottiRecruiting |
| Azienda Ospedaliero-Universitaria | Sassari, Italy Recruiting |
| A.O. S. Maria | Terni, Italy Recruiting |
| A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2 | Torino, Italy, 10134 Contact: Umberto Vitolo, M.D. | uvitolo@molinette.piemonte.itPrincipal Investigator: Umberto Vitolo, M.D. Recruiting |
| Ospedale di Circolo Fondazione Macchi | Varese, Italy Contact: Graziella Pinotti, MDNot yet recruiting |
| IOSI | Bellinzona, Switzerland, 6500 Contact: Emanuele Zucca, MD | +41 91 8119040 | ielsg@ticino.comPrincipal Investigator: Emanuele Zucca, M.D. Recruiting |