Large B-cell Diffuse Lymphoma of TestisPhase 2IELSG30NCT00945724
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
A Phase 2 study testing Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate in people with Large B-cell Diffuse Lymphoma of Testis, run by International Extranodal Lymphoma Study Group (IELSG) at 22 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Large B-cell Diffuse Lymphoma of Testis
- What is being tested?
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 27 Sep 2009to 26 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Orchiectomy is mandatory, before enrolment of the patient into the study.
- Orchiectomy should be performed within 2 months before study entry.
- Age 18-80
- Untreated patients
- 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.
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- Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
- Adequate haematological counts: ANC > 1.0 x 109/L and PLTs count > 75 x 109/L
- Cardiac ejection fraction ≥ 45% by MUGA scan or echocardiography
- Non peripheral neuropathy or any active non-neoplastic CNS disease.
- No other major life-threatening illnesses that may preclude chemotherapy
- Conjugated bilirubin ≤ 2 x ULN.
- Alkaline phosphatase and transaminases ≤ 2 x ULN.
- Creatinine clearances ≥ 45 ml/min.
- HIV negativity
- HBV negativity or patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
- HCV negativity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
- Life expectancy > 6 months.
- Performance status < 2 according to ECOG scale.
- No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
- Written informed Consent
Who cannot join
- Has known or suspected hypersensitivity or intolerance to rituximab
- History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
- 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
- History of clinically relevant hypotension
- CNS involvement (meningeal and/or brain involvement by lymphoma)
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- Evolving malignancy within 3 years with the exception of localized non-melanomatous skin cancer
- HIV positivity
- HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
- HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
- Active opportunistic infection
- Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy
- Exposure to Rituximab prior study entry
- 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.
- Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Italy21 sites
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Spedali Civili
Brescia
Ematologia Ospedale Businco
Cagliari
S. Martino Hospital
Genova
European Institute of Oncology
Milan
San Raffaele H Scientific Institute
Milan
Policlinico
Modena
A.O. San Gerardo
Monza
AOU Maggiore della Carità
Novara
S. Matteo
Pavia
Ospedale Civile
Piacenza
U.O. Ematologia AUSL Ravenna
Ravenna
Arcispedale Santa Maria Nuova
Reggio Emilia
IFO Regina Elena
Roma
Policlinico Universitario Campus Biomedico
Roma
Università La Sapienza
Rome
Humanitas
Rozzano
Azienda Ospedaliero-Universitaria
Sassari
A.O. S. Maria
Terni
A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2
Torino, 10134
Ospedale di Circolo Fondazione Macchi
Varese
About this study
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
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.
- Conditions
- Large B-cell Diffuse Lymphoma of Testis
- Being tested
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexateDrug
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 group | Role | What they receive |
|---|---|---|
| R-CHOP, Depocyte, Methotrexate | Experimental | Not described Receives: Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Assessment
Number of patients who withdrew the treatment due to adverse event
Measured: 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 outcomes (3)
5 Year Cumulative Incidence of Progressions
Percentage of patients with disease progression after achieving a remission
Measured: From the first documented response to relapse until 5 years from study entry
5 Years Progression Free Survival (PFS)
Percentage of patients free from disease progression after 5 years from study entry
Measured: From study entry until 5 years after
5 Years Overall Survival (OS)
Percentage of patients alive after 5 years from study entry
Measured: From study entry until 5 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study start27 Sep 2009
- Primary completionJun 2019
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Large B-cell Diffuse Lymphoma of TestisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emanuele Zucca, MD, Study chair, IOSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945724
- Sponsor's protocol ID
- IELSG30
- Other IDs
- EudraCT Number 2009-011789-26
- Acronym
- IELSG30
- Status last verified
- May 2025
- First submitted
- 23 Jul 2009
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Conconi A, Chiappella A, Ferreri AJM, Stathis A, Botto B, Sassone M, Gaidano G, Balzarotti M, Merli F, Tucci A, Vanazzi A, Tani M, Bruna R, Orsucci L, Cabras MG, Celli M, Annibali O, Liberati AM, Zanni M, Ghiggi C, Pisani F, Pinotti G, Dore F, Esposito F, Pirosa MC, Cesaretti M, Bonomini L, Vitolo U, Zucca E. IELSG30 phase 2 trial: intravenous and intrathecal CNS prophylaxis in primary testicular diffuse large B-cell lymphoma. Blood Adv. 2024 Mar 26;8(6):1541-1549. doi: 10.1182/bloodadvances.2023011251.
PubMed 38181782
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00945724
- Acronym / sponsor ID
- IELSG30 / IELSG30
- Conditions
- Large B-cell Diffuse Lymphoma of Testis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- 27 Sep 2009 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-CHOP, Depocyte, Methotrexate | Experimental | Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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).
- Orchiectomy is mandatory, before enrolment of the patient into the study.
- Orchiectomy should be performed within 2 months before study entry.
- Age 18-80
- Untreated patients
Key exclusion criteria (15 listed)
- Has known or suspected hypersensitivity or intolerance to rituximab
- History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
- 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
- History of clinically relevant hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexateWeeks 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) | Drug | R-CHOP, Depocyte, Methotrexate |
Primary outcome
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
3 secondary outcomes
5 Year Cumulative Incidence of Progressions
Time frame: 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
5 Years Overall Survival (OS)
Time frame: From study entry until 5 years after
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38181782Conconi A, Chiappella A, Ferreri AJM, Stathis A, Botto B, Sassone M, Gaidano G, Balzarotti M, Merli F, Tucci A, Vanazzi A, Tani M, Bruna R, Orsucci L, Cabras MG, Celli M, Annibali O, Liberati AM, Zanni M, Ghiggi C, Pisani F, Pinotti G, Dore F, Esposito F, Pirosa MC, Cesaretti M, Bonomini L, Vitolo U, Zucca E. IELSG30 phase 2 trial: intravenous and intrathecal CNS prophylaxis in primary testicular diffuse large B-cell lymphoma. Blood Adv. 2024 Mar 26;8(6):1541-1549. doi: 10.1182/bloodadvances.2023011251.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuele Zucca, MD study chair
IOSI
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate in people with Large B-cell Diffuse Lymphoma of Testis, run by International Extranodal Lymphoma Study Group (IELSG) at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00945724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.