Know Cancer

or
forgot password

A Phase II Study of R-CHOP With Intensive CNS Prophylaxis and Scrotal Irradiation in Patients With Primary Testicular Diffuse Large B-cell Lymphoma


Phase 2
18 Years
80 Years
Open (Enrolling)
Male
Primary Testicular Diffuse Large B-cell Lymphoma

Thank you

Trial Information

A Phase II Study of R-CHOP With Intensive CNS Prophylaxis and Scrotal Irradiation in Patients With Primary Testicular Diffuse Large B-cell Lymphoma


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Emanuele Zucca, MD

Investigator Role:

Study Chair

Investigator Affiliation:

IOSI

Authority:

Switzerland: Swissmedic

Study ID:

IELSG30

NCT ID:

NCT00945724

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Primary Testicular Diffuse Large B-cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location