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Randomized Phase II Trial on Primary Chemotherapy With High-dose Methotrexate, Alone or Associated With High-dose Cytarabine, Followed by Response- and Age-tailored Radiotherapy for Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma


Phase 2
18 Years
75 Years
Not Enrolling
Both
Lymphoma, B Cell

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Trial Information

Randomized Phase II Trial on Primary Chemotherapy With High-dose Methotrexate, Alone or Associated With High-dose Cytarabine, Followed by Response- and Age-tailored Radiotherapy for Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma


Inclusion Criteria:



1. Histological or cytological diagnosis of non-Hodgkin's lymphoma.

2. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology
examination or vitrectomy.

3. Disease exclusively localized into the central nervous system, cranial nerves or
eyes.

4. Untreated patients (patients treated with steroids alone are eligible).

5. At least one measurable lesion.

6. Age 18 - 75 years.

7. ECOG performance status < 3

8. HBsAg-negative and Ab anti-HCV-negative serologic status.

9. No known HIV disease or immunodeficiency.

10. Adequate bone marrow (PLT > 100000 mm3, Hb ≥ 9 g/dl, ANC ≥ 2.000 mm3), renal
(creatinine clearance ≥ 60 mL/min), cardiac (VEF ≥ 50%), and hepatic function (total
serum bilirubin < 3 mg/dL, AST/ALT and gGT < 2 per upper normal limit value).

11. No previous or concurrent malignancies with the exception of surgically cured
cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin
cancer and of other cancers without evidence of disease since at least 5 years
(patients with a previous lymphoma diagnosis will be excluded).

12. Absence of any familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule.

13. Non-pregnant and non-lactating status for female patients. Adequate contraceptive
measures during study participation for sexually active patients of childbearing
potential.

14. No concurrent treatment with other experimental drugs.

15. Informed consent signed by the patient before registration

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The main endpoint is the complete remission (CR) rate after chemotherapy

Principal Investigator

Andres JM Ferreri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Radiochemotherapy. San Raffaele Hospital. Milan

Authority:

Switzerland: Swissmedic

Study ID:

IELSG20

NCT ID:

NCT00210314

Start Date:

July 2003

Completion Date:

December 2007

Related Keywords:

  • Lymphoma, B Cell
  • Lymphoma
  • Lymphoma, B-Cell

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