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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. (see Contacts and Locations)
Verified March 2013 by International Extranodal Lymphoma Study Group (IELSG)
Sponsor:
Information provided by (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
  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:


Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • Adverse events assessments [ Time Frame: throughout the active treatment period until 30 days after the last drug administration ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: April 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R-CHOP, Depocyte, Methotrexate 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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
European Institute of Oncology Recruiting
Milan, Italy
Principal Investigator: Giovanni Martinelli, MD         
San Raffaele H Scientific Institute Recruiting
Milan, Italy
Contact: Andres Ferreri, MD       ferreri.andres@hsr.it   
Principal Investigator: Andrés JM Ferreri, 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: November 22, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Methotrexate
Rituximab
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on November 27, 2014