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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00945724
Recruitment Status : Recruiting
First Posted : July 24, 2009
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)

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.

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)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2009
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: R-CHOP, Depocyte, Methotrexate Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate

Weeks 1-15:

  • 6 cycles of CHOP on Days 1 to 5, to be repeated q21 Days
  • Rituximab 375 mg/m2 on Day 0 or Day 1 of every CHOP cycle
  • IT chemoth:Depocyte 50 mg on Day 0 of cycles 2,3,4&5 of R-CHOP

Weeks 18-22:

• 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)

Primary Outcome Measures :
  1. Adverse events assessments [ Time Frame: throughout the active treatment period until 30 days after the last drug administration ]
  2. 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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00945724

Contact: Emanuele Zucca, MD ++41918119040

A.O. SS. Antonio e Biagio e Cesare Arrigo Recruiting
Alessandria, Italy
Contact: Flavia Salvi, MD         
Spedali Civili Recruiting
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Ematologia Ospedale Businco Recruiting
Cagliari, Italy
Contact: Giuseppina Cabras, MD         
S. Martino Hospital Recruiting
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European Institute of Oncology Recruiting
Milan, Italy
Principal Investigator: Giovanni Martinelli, MD         
San Raffaele H Scientific Institute Recruiting
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Contact: Andres Ferreri, MD   
Principal Investigator: Andrés JM Ferreri, MD         
Policlinico Recruiting
Modena, Italy
A.O. San Gerardo Recruiting
Monza, Italy
AOU Maggiore della Carità Recruiting
Novara, Italy
S. Matteo Recruiting
Pavia, Italy
Principal Investigator: Luca Arcaini, MD         
Ospedale Civile Recruiting
Piacenza, Italy
U.O. Ematologia AUSL Ravenna Recruiting
Ravenna, Italy
Arcispedale Santa Maria Nuova Recruiting
Reggio Emilia, Italy
IFO Regina Elena Recruiting
Roma, Italy
Principal Investigator: Francesco Pisani, MD         
Policlinico Universitario Campus Biomedico Recruiting
Roma, Italy
Contact: Giuseppe Avvisati, MD         
Università La Sapienza 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.   
Principal Investigator: Umberto Vitolo, M.D.         
Ospedale di Circolo Fondazione Macchi Recruiting
Varese, Italy
Contact: Graziella Pinotti, MD         
IOSI Recruiting
Bellinzona, Switzerland, 6500
Contact: Emanuele Zucca, MD    +41 91 8119040   
Principal Investigator: Emanuele Zucca, M.D.         
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Study Chair: Emanuele Zucca, MD IOSI

Responsible Party: International Extranodal Lymphoma Study Group (IELSG) Identifier: NCT00945724     History of Changes
Other Study ID Numbers: IELSG30
EudraCT Number 2009-011789-26
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors