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

NCT00945724 | Completed Phase 2 Results

• 2 other identifiers: IELSG30EudraCT Number 2009-011789-26
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 22

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.

Conditions

Large B-cell Diffuse Lymphoma of Testis

Outcome Measures

Primary Outcomes (1)

• Adverse Events Assessment

  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 Outcomes (3)

• 5 Year Cumulative Incidence of Progressions

  From the first documented response to relapse until 5 years from study entry

• 5 Years Progression Free Survival (PFS)

  From study entry until 5 years after

• 5 Years Overall Survival (OS)

  From study entry until 5 years after

Study Arms (1)

R-CHOP, Depocyte, Methotrexate

EXPERIMENTAL

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

Interventions

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate DRUG

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)

R-CHOP, Depocyte, Methotrexate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• International Extranodal Lymphoma Study Group (IELSG): lead

Study Sites (22)

A.O. SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Location

Spedali Civili

Brescia, Italy

Location

Ematologia Ospedale Businco

Cagliari, Italy

Location

S. Martino Hospital

Genova, Italy

Location

European Institute of Oncology

Milan, Italy

Location

San Raffaele H Scientific Institute

Milan, Italy

Location

Policlinico

Modena, Italy

Location

A.O. San Gerardo

Monza, Italy

Location

AOU Maggiore della Carità

Novara, Italy

Location

S. Matteo

Pavia, Italy

Location

Ospedale Civile

Piacenza, Italy

Location

U.O. Ematologia AUSL Ravenna

Ravenna, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

Location

IFO Regina Elena

Roma, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, Italy

Location

Università La Sapienza

Rome, Italy

Location

Humanitas

Rozzano, Italy

Location

Azienda Ospedaliero-Universitaria

Sassari, Italy

Location

A.O. S. Maria

Terni, Italy

Location

A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2

Torino, 10134, Italy

Location

Ospedale di Circolo Fondazione Macchi

Varese, Italy

Location

IOSI

Bellinzona, 6500, Switzerland

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisolone; Methotrexate

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Aminopterin; Pterins; Pteridines

Results Point of Contact

• Title: Scientific and Medical Director
• Organization: International Extranodal Lymphoma Study Group (IELSG)

ielsg@ior.usi.ch

+41 58 666

Study Officials

• Emanuele Zucca, MD

  IOSI

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 24, 2009
• Study Start: September 27, 2009
• Primary Completion: June 1, 2019
• Study Completion: September 26, 2023
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Locations

IT (21); CH (1)