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


Phase 2
18 Years
N/A
Not Enrolling
Male
Lymphoma, B Cell

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Trial Information

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


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

11. Have given written informed consent prior to any program-specific screening
procedure, with the understanding that the consent may be withdrawn by the patient at
any time without prejudice

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Principal Investigator

Andreas Sarris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

International Extranodal Lymphoma Study Group

Authority:

Switzerland: Swissmedic

Study ID:

IELSG10

NCT ID:

NCT00210379

Start Date:

November 2000

Completion Date:

March 2007

Related Keywords:

  • Lymphoma, B Cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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