HIGH-DOSE SEQUENTIAL CHEMOTHERAPY AND RITUXIMAB (R-HDS) SUPPORTED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH SYSTEMIC B-CELL LYMPHOMA WITH CENTRAL NERVOUS SYSTEM INVOLVEMENT AT DIAGNOSIS OR RELAPSE - ND

• Conditions: PATIENTS WITH SYSTEMIC B-CELL LYMPHOMA WITH CENTRAL NERVOUS SYSTEM INVOLVEMENT AT DIAGNOSIS OR RELAPSE; MedDRA version: 9.1Level: LLTClassification code 10003899Term: B-cell lymphoma

• Registration Number: EUCTR2006-006999-38-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Histologically confirmed diagnosis of diffuse large-cell, follicular or mantle cell lymphoma

2.CNS involvement (brain, meninges, cranial nerves, eyes and/or spinal cord) at diagnosis or relapse after conventional chemotherapy

3.Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination; neuroimaging alone is acceptable only when stereotactic biopsy is formally contraindicated

4.Age 19-65 years

5.ECOG performance status 0-3

6.Adequate bone marrow (PLT ?100000 mm3, Hb ?9 gr/dL, ANC ?2000 mm3), renal (creatinine clearance ?60 mL/min), cardiac (VEF > 50%), and hepatic function (total serum bilirubin <=3 mg/dL, AST/ALT and GGT <=2.5 per upper normal limit value), within 1 week prior to study start (unless the abnormality is due to lymphoma involvement)

7.Absence of symptomatic coronary artery disease, cardiac arhythmias not well controlled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)

8.Absence of HIV infection

9.No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix and carcinoma of the skin and of other cancers without evidence of disease at least from 5 years

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

11.Female patients must be non-pregnant and non-lactating. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation

12.No treatment with other experimental drugs within the 6 weeks previous to enrolment

13.Given written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

age under 19 and over 65; pregnancy and breast feeding; patients under treatment with sperimental drugs;..

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 2-year event-free survival;Secondary Objective: 1.response duration and overall survival<br><br>2.complete remission rate<br><br>3.tolerability<br><br>4.neurotoxicity;Primary end point(s): 2-year event-free survival