High-Dose Sequential Chemotherapy and Rituximab (R-HDS) in Patients With Systemic B-Cell Lymphoma With Central Nervous System Involvement at Diagnosis or Relapse
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 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 gammaGT < 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 arrhythmias 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. Give 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
Exclusion Criteria:
- NA