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)

May 28, 2025 updated by: International Extranodal Lymphoma Study Group (IELSG)

A Phase II Study of R-CHOP With Intensive CNS Prophylaxis and Scrotal Irradiation in Patients With Primary Testicular Diffuse Large B-cell Lymphoma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • A.O. SS. Antonio e Biagio e Cesare Arrigo
      • Brescia, Italy
        • Spedali Civili
      • Cagliari, Italy
        • Ematologia Ospedale Businco
      • Genova, Italy
        • S. Martino Hospital
      • Milan, Italy
        • European Institute of Oncology
      • Milan, Italy
        • San Raffaele H Scientific Institute
      • Modena, Italy
        • Policlinico
      • Monza, Italy
        • A.O. San Gerardo
      • Novara, Italy
        • Aou Maggiore Della Carita
      • Pavia, Italy
        • S. Matteo
      • Piacenza, Italy
        • Ospedale Civile
      • Ravenna, Italy
        • U.O. Ematologia AUSL Ravenna
      • Reggio Emilia, Italy
        • Arcispedale Santa Maria Nuova
      • Roma, Italy
        • Policlinico Universitario Campus Biomedico
      • Roma, Italy
        • IFO Regina Elena
      • Rome, Italy
        • Università La Sapienza
      • Rozzano, Italy
        • Humanitas
      • Sassari, Italy
        • Azienda Ospedaliero-Universitaria
      • Terni, Italy
        • A.O. S. Maria
      • Torino, Italy, 10134
        • A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2
      • Varese, Italy
        • Ospedale di Circolo Fondazione Macchi
  • Switzerland
      • Bellinzona, Switzerland, 6500
        • IOSI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events Assessment
Time Frame: From treatment start until the last drug administration, up to week 22 for the 'R-CHOP, Depocyte, Methotrexate' Group, up to 15 weeks (Weeks 1-15) for the 'R-CHOP + Lyposomal Cytarabine' Group, and from week 18-22 for the 'HD-MTX' Group
Number of patients who withdrew the treatment due to adverse event
From treatment start until the last drug administration, up to week 22 for the 'R-CHOP, Depocyte, Methotrexate' Group, up to 15 weeks (Weeks 1-15) for the 'R-CHOP + Lyposomal Cytarabine' Group, and from week 18-22 for the 'HD-MTX' Group

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
5 Year Cumulative Incidence of Progressions
Time Frame: From the first documented response to relapse until 5 years from study entry
Percentage of patients with disease progression after achieving a remission
From the first documented response to relapse until 5 years from study entry
5 Years Progression Free Survival (PFS)
Time Frame: From study entry until 5 years after
Percentage of patients free from disease progression after 5 years from study entry
From study entry until 5 years after
5 Years Overall Survival (OS)
Time Frame: From study entry until 5 years after
Percentage of patients alive after 5 years from study entry
From study entry until 5 years after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Extranodal Lymphoma Study Group (IELSG)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Emanuele Zucca, MD, IOSI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IELSG30
  • EudraCT Number 2009-011789-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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