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NCT00945724 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2025-05-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Adverse Events Assessment

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outcome · POSTED

5 Year Cumulative Incidence of Progressions

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outcome · POSTED

5 Years Progression Free Survival (PFS)

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outcome · POSTED

5 Years Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
80 Years
minimum Age
18 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate
    label
    R-CHOP, Depocyte, Methotrexate
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. R-CHOP, Depocyte, Methotrexate
    description
    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)
    name
    Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
54
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of patients who withdrew the treatment due to adverse event
    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
secondary Outcomes
  1. description
    Percentage of patients with disease progression after achieving a remission
    measure
    5 Year Cumulative Incidence of Progressions
    time Frame
    From the first documented response to relapse until 5 years from study entry
  2. description
    Percentage of patients free from disease progression after 5 years from study entry
    measure
    5 Years Progression Free Survival (PFS)
    time Frame
    From study entry until 5 years after
  3. description
    Percentage of patients alive after 5 years from study entry
    measure
    5 Years Overall Survival (OS)
    time Frame
    From study entry until 5 years after
Full study description
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.
Source references
references
  1. citation
    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.
    pmid
    38181782
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
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      payload
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      true
      id
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT00945724
        start
        0
      offset unit
      unicode_code_points
      query cond
      Primary Central Nervous System Lymphoma
      query disease state id
      ds-primary-central-nervous-system-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-primary-central-nervous-system-lymphoma-000.json
      source file sha256
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      source json pointer
      /studies/5/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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    Preserved source evidence · Not medical advice