Status:
COMPLETED
High-dose Sequential Chemoimmunotherapy for B-cell Lymphomas With Central Nervous System Involvement
Lead Sponsor:
Andrés José Maria Ferreri
Collaborating Sponsors:
Mundipharma Pte Ltd.
Conditions:
B-cell Lymphomas
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 involvemen...
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, ri...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of diffuse large-cell, follicular or mantle cell lymphoma
- CNS involvement (brain, meninges, cranial nerves, eyes, and/or spinal cord) at diagnosis or relapse after conventional chemotherapy
- Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination. Neuroimaging alone is acceptable only when stereotactic biopsy is formally contraindicated.
- Age 18-70 years
- ECOG performance status 0-3
- 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)
- 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)
- Absence of HIV infection
- 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
- Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Female patients must be non-pregnant and non-lactating. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
- No treatment with other experimental drugs within the 6 weeks previous to enrolment
- 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
- NA
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00801216
Start Date
January 1 2007
End Date
January 1 2013
Last Update
December 10 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
San Raffaele Scientific Institute
Milan, Italy, 20132