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)

• ClinicalTrials.gov Identifier: NCT00945724
• Recruitment Status: Active, not recruiting
• First Posted: July 24, 2009
• Last Update Posted: June 7, 2021
• Sponsor: International Extranodal Lymphoma Study Group (IELSG)
• Information provided by (Responsible Party): International Extranodal Lymphoma Study Group (IELSG)

Tracking Information

• First Submitted Date: July 23, 2009
• First Posted Date: July 24, 2009
• Last Update Posted Date: June 7, 2021
• Study Start Date: April 2009
• Actual Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 22, 2013)

• 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 ]

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Large B-cell Diffuse Lymphoma of Testis

Intervention

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)

Study Arms

Experimental: R-CHOP, Depocyte, Methotrexate

Intervention: Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 28, 2019): 54
• Original Estimated Enrollment (submitted: July 23, 2009): 35
• Estimated Study Completion Date: December 2022
• Actual Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy, Switzerland

Administrative Information

• NCT Number: NCT00945724
• Other Study ID Numbers: IELSG30; EudraCT Number 2009-011789-26
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: International Extranodal Lymphoma Study Group (IELSG)
• Original Responsible Party: international Extranodal Lymphoma Study Group (IELSG), IELSG
• Current Study Sponsor: International Extranodal Lymphoma Study Group (IELSG)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Emanuele Zucca, MD; IOSI

• PRS Account: International Extranodal Lymphoma Study Group (IELSG)
• Verification Date: June 2021