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

International Extranodal Lymphoma Study Group (IELSG)1 site in 1 country64 target enrollmentNovember 2000

ConditionsLymphoma, B Cell

Drugsrituximab CHOP intrathecal methotrexate

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lymphoma, B Cell
Sponsor: International Extranodal Lymphoma Study Group (IELSG)
Enrollment: 64
Locations: 1
Primary Endpoint: Event-free survival
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

November 2000

End Date

March 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

International Extranodal Lymphoma Study Group (IELSG)

Eligibility Criteria

Inclusion Criteria

•age = 18 years.
•ECOG performance status 0-2
•Histologically proven primary testicular CD20-positive diffuse large B-cell non-Hodgkin's lymphoma, untreated
•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.
•Bidimensionally measurable or evaluable disease. Patients who have had all disease removed by surgery are eligible.
•Adequate bone marrow reserve (ANC \> 1.000/L, Plt \> 100.000/L)
•Cardiac ejection fraction ≥ 50% by MUGA scan or echocardiography
•No previous therapy with monoclonal antibody anti-CD
•No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
•No other major life-threatening illnesses that may preclude chemotherapy

Exclusion Criteria

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