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

Tracking Information
First Submitted Date  ICMJE July 23, 2009
First Posted Date  ICMJE July 24, 2009
Last Update Posted Date June 7, 2021
Study Start Date  ICMJE April 2009
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Large B-cell Diffuse Lymphoma of Testis
Intervention  ICMJE 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  ICMJE Experimental: R-CHOP, Depocyte, Methotrexate
Intervention: Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 28, 2019)
54
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2009)
35
Estimated Study Completion Date  ICMJE December 2022
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00945724
Other Study ID Numbers  ICMJE IELSG30
EudraCT Number 2009-011789-26
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Extranodal Lymphoma Study Group (IELSG)
Study Sponsor  ICMJE International Extranodal Lymphoma Study Group (IELSG)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Emanuele Zucca, MD IOSI
PRS Account International Extranodal Lymphoma Study Group (IELSG)
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP