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

NCT ID: NCT00945724

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-27
• Study Completion Date: 2023-09-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-CHOP, Depocyte, Methotrexate

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

Interventions

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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

International Extranodal Lymphoma Study Group (IELSG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emanuele Zucca, MD

Role: STUDY_CHAIR

IOSI

Locations

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

Alessandria, , Italy

Spedali Civili

Brescia, , Italy

Ematologia Ospedale Businco

Cagliari, , Italy

S. Martino Hospital

Genova, , Italy

European Institute of Oncology

Milan, , Italy

San Raffaele H Scientific Institute

Milan, , Italy

Policlinico

Modena, , Italy

A.O. San Gerardo

Monza, , Italy

AOU Maggiore della Carità

Novara, , Italy

S. Matteo

Pavia, , Italy

Ospedale Civile

Piacenza, , Italy

U.O. Ematologia AUSL Ravenna

Ravenna, , Italy

Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

IFO Regina Elena

Roma, , Italy

Policlinico Universitario Campus Biomedico

Roma, , Italy

Università La Sapienza

Rome, , Italy

Humanitas

Rozzano, , Italy

Azienda Ospedaliero-Universitaria

Sassari, , Italy

A.O. S. Maria

Terni, , Italy

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

Torino, , Italy

Ospedale di Circolo Fondazione Macchi

Varese, , Italy

IOSI

Bellinzona, , Switzerland

Countries

Italy; Switzerland

References

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.

Reference Type: DERIVED

PMID: 38181782 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EudraCT Number 2009-011789-26

Identifier Type: -

Identifier Source: secondary_id

IELSG30

Identifier Type: -

Identifier Source: org_study_id