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Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma

A Phase II Study of CHOP + Rituximab, With Intrathecal Methotrexate Followed by Radiotherapy in Patients With Primary Testicular Non-Hodgkin's Lymphoma

NCT00210379•International Extranodal Lymphoma Study Group (IELSG)

View on ClinicalTrials.gov

Summary

The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular DLCL and to assess the toxicity of this therapeutic strategy

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. age = 18 years.
•2. ECOG performance status 0-2
•3. Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
•4. Ann Arbor stage IE or IIE. Bilateral testicular involvement at presentation will not be considered stage IV. In these patients the final Ann Arbor stage will be determined by the extent of nodal involvement.
•5. Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
•6. Adequate bone marrow reserve (ANC \> 1.000/L, Plt \> 100.000/L)
•7. Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
•8. No previous therapy with monoclonal antibody anti-CD20.
•9. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
•10. No other major life-threatening illnesses that may preclude chemotherapy
+1 more criteria

Exclusion Criteria

•1. impairment of renal function (creatinine \> 2 mg/dl) or liver function (bilirubin \> 2 mg/dl) unless due to lymphoma involvement
•2. HIV positive patients
•3. evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer

Locations (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, Switzerland

Key Dates

Start Date

November 1, 2000

Primary Completion Date

November 1, 2004

Completion Date

March 1, 2007

Last Updated

July 22, 2009

Enrollment

ACTUAL participants

Conditions

Lymphoma, B Cell

Interventions

rituximab

DRUG

CHOP

DRUG

intrathecal methotrexate

DRUG

radiotherapy

PROCEDURE

The Safety, Pharmacokinetic and Pharmacodynamic Effect of KA2237 (PI3 Kinase p110β/δ Inhibitor) In B Cell Lymphoma

NCT02679196

Lymphoma, B Cell

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UNKNOWNPHASE4

Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for CD19+ B Cell Lymphoma

NCT02992834

Lymphoma, B Cell

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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