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Trial Title:
High-Dose Sequential Chemoimmunotherapy for B-Cell Lymphomas With Central Nervous System Involvement
NCT ID:
NCT00801216
Condition:
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:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
High-dose sequential chemotherapy and autologous transplant
Description:
Two courses of methotrexate 3.5 g/mq day 1 and cytarabine 2 g/mq twice a day, for two
days, Rituximab 375 mg/mq days 3 & 11 and Intrathecal liposomal cytarabine 50 mg day
6(Phase I) followed in case of response by cyclophosphamide 7 g/mq plus Rituximab 375
mg/mq and Intrathecal liposomal cytarabine 50 mg Leukapheresis A and cryopreservation
(Phase II), Cytarabine 2 g/mq twice a day for 4 days, Rituximab 375 mg/m2 and Reinfusion
of stem cells (Phase III), etoposide 2 g/mq, Intrathecal liposomal cytarabine 50 mg
(Phase IV) and high-dose Thiotepa-BCNU supported by autologous stem cell transplant
(Phase V), and whole-brain radiotherapy in patients who do not achieve a complete
remission after chemotherapy (Phase VI)
Arm group label:
High-dose sequential chemoimmunotherapy
Other name:
Depocyte
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 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:
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
Gender:
All
Minimum age:
19 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
San Raffaele Scientific Institute
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Roberto Crocchiolo, MD
Email:
roberto.crocchiolo@hsr.it
Contact backup:
Last name:
Silvia Govi, MD
Email:
silvia.govi@hsr.it
Investigator:
Last name:
Andrea Assanelli, MD
Email:
Sub-Investigator
Facility:
Name:
San Raffaele Scientific Institute
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Roberto Crocchiolo, MD
Email:
Sub-Investigator
Investigator:
Last name:
Silvia Govi, MD
Email:
Sub-Investigator
Start date:
January 2007
Completion date:
January 2012
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Collaborator:
Agency:
Mundipharma K.K.
Agency class:
Industry
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00801216
