High-Dose Sequential Chemoimmunotherapy for B-Cell Lymphomas With Central Nervous System Involvement
B-Cell Lymphomas
Conditions: official terms
Lymphoma - Lymphoma, B-Cell
Conditions: Keywords
B-cell lymphomas, lymphomatous meningitis, liposomal cytarabine, autologous transplant, CNS involvement, Secondary CNS lymphomas
Study Type
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: High-dose sequential chemotherapy and autologous transplant
Type: Drug
Overall Status
This prospective trial will assess the activity and feasibility of a new high-dose methotrexate-based high-dose sequential chemotherapy combination in patients with B-cell lymphomas and CNS involvement at diagnosis or relapse. Selected drugs, with a well-documented anti-lymphoma activity, will be administered at high doses to increase blood-brain barrier penetration and CNS bioavailability as well as to reduce potential cross-resistance.
Detailed Description
Patients with aggressive B-cell lymphoma and involvement of the central nervous system at diagnosis or relapse will be treated with a combination of high-dose methotrexate and high-dose cytarabine, rituximab, and intrathecal depocyte followed by rituximab-high-dose sequential chemotherapy supported by autologous tsem cell transplantation.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 19 Years
Gender: Both
Criteria: 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
San Raffaele Scientific Institute
Milan, Italy
Status: Recruiting
Contact: Roberto Crocchiolo, MD - roberto.crocchiolo@hsr.it
San Raffaele Scientific Institute
Milan, Italy
Status: Recruiting
Start Date
January 2007
Completion Date
January 2012
IRCCS San Raffaele
IRCCS San Raffaele
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page