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 (IELSG30)
This study is currently recruiting participants.
Verified March 2013 by International Extranodal Lymphoma Study Group (IELSG)
Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00945724
First received: July 23, 2009
Last updated: March 8, 2013
Last verified: March 2013
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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 | Intervention | Phase |
|---|---|---|
|
Primary Testicular Diffuse Large B-cell Lymphoma |
Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Cyclophosphamide
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methotrexate
Methylprednisolone
Prednisolone sodium phosphate
Cytarabine
Prednisolone phosphate
Prednisolone sodium succinate
Vincristine sulfate
Methylprednisolone sodium succinate
Methotrexate sodium
Doxorubicin
Doxorubicin hydrochloride
Rituximab
U.S. FDA Resources
Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):
| Estimated Enrollment: | 35 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate
- 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)
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
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945724
Contacts
| Contact: Emanuele Zucca, MD | ++41918119040 | ielsg@ticino.com |
Locations
| Italy | |
| A.O. SS. Antonio e Biagio e Cesare Arrigo | Not yet recruiting |
| Alessandria, Italy | |
| Contact: Flavia Salvi, MD | |
| Comprensorio Sanitario di Bolzano | Not yet recruiting |
| Bolzano, Italy | |
| Principal Investigator: Sergio Cortelazzo, MD | |
| Spedali Civili | Not yet recruiting |
| Brescia, Italy | |
| S. Martino Hospital | Not yet recruiting |
| Genova, Italy | |
| A.O.Papardo | Not yet recruiting |
| Messina, Italy | |
| San Raffaele H Scientific Institute | Recruiting |
| Milan, Italy | |
| Contact: Andres Ferreri, MD ferreri.andres@hsr.it | |
| Principal Investigator: Andrés JM Ferreri, MD | |
| European Institute of Oncology | Recruiting |
| Milan, Italy | |
| Principal Investigator: Giovanni Martinelli, MD | |
| Policlinico | Not yet recruiting |
| Modena, Italy | |
| A.O. San Gerardo | Not yet recruiting |
| Monza, Italy | |
| Università Federico II | Not yet recruiting |
| Napoli, Italy | |
| AOU Maggiore della Carità | Recruiting |
| Novara, Italy | |
| S. Matteo | Not yet recruiting |
| Pavia, Italy | |
| Principal Investigator: Luca Arcaini, MD | |
| Ospedale Civile | Not yet recruiting |
| Piacenza, Italy | |
| U.O. Ematologia AUSL Ravenna | Recruiting |
| Ravenna, Italy | |
| A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia | Not yet recruiting |
| Reggio Calabria, Italy | |
| Principal Investigator: Caterina Stelitano, MD | |
| Arcispedale Santa Maria Nuova | Recruiting |
| Reggio Emilia, Italy | |
| IFO Regina Elena | Recruiting |
| Roma, Italy | |
| Principal Investigator: Francesco Pisani, MD | |
| Università La Sapienza | Not yet recruiting |
| Rome, Italy | |
| Humanitas | Recruiting |
| Rozzano, Italy | |
| Contact: Monica Balzarotti | |
| Azienda Ospedaliero-Universitaria | Recruiting |
| Sassari, Italy | |
| A.O. S. Maria | Recruiting |
| Terni, Italy | |
| A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2 | Recruiting |
| Torino, Italy, 10134 | |
| Contact: Umberto Vitolo, M.D. uvitolo@molinette.piemonte.it | |
| Principal Investigator: Umberto Vitolo, M.D. | |
| Ospedale di Circolo Fondazione Macchi | Not yet recruiting |
| Varese, Italy | |
| Contact: Graziella Pinotti, MD | |
| Switzerland | |
| IOSI | Recruiting |
| Bellinzona, Switzerland, 6500 | |
| Contact: Emanuele Zucca, MD +41 91 8119040 ielsg@ticino.com | |
| Principal Investigator: Emanuele Zucca, M.D. | |
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
| Study Chair: | Emanuele Zucca, MD | IOSI |
More Information
No publications provided
| Responsible Party: | International Extranodal Lymphoma Study Group (IELSG) |
| ClinicalTrials.gov Identifier: | NCT00945724 History of Changes |
| Other Study ID Numbers: | IELSG30, EudraCT Number 2009-011789-26 |
| Study First Received: | July 23, 2009 |
| Last Updated: | March 8, 2013 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Cytarabine Methotrexate Rituximab Doxorubicin |
Prednisolone Methylprednisolone Hemisuccinate Vincristine Methylprednisolone acetate Prednisolone acetate Methylprednisolone Prednisolone hemisuccinate Prednisolone phosphate Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 22, 2013