An international phase II trial assessing tolerability and efficacy of sequential Methotrexate-Aracytin-based combination and R-ICE combination, followed by high-dose chemotherapy supported by autologous stem cell transplant, in patients with systemic B-cell lymphoma with central nervous system involvement at diagnosis or relapse (MARIETTA regimen)
- Conditions
- B-cell lymphoma with central nervous system involvementnon hodgkin lymphoma in brain/spinal cord10025320
- Registration Number
- NL-OMON45024
- Lead Sponsor
- IELSG Coordination Centre, Oncology Institute of Southern Switzerland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 13
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma
- CNS involvement (brain, meninges, cranial nerves, eyes and/or spinal cord) at diagnosis (concomitant to extra-CNS disease) at diagnosis or relapse after conventional chemo(-immuno)therapy
- Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination. Neuroimaging alone is acceptable when stereotactic biopsy is formally contraindicated or when the disease has been previously histologically documented in other areas and the CNS localization is concomitant with a diffuse progression of systemic disease.
- No previous treatment with high-dose methotrexate-based chemotherapy and/or brain irradiation. One-two courses of R-CHOP combination as upfront therapy are admitted in patients with large amount and/or extensive extra-CNS disease that could condition prognosis in an early phase of treatment. Local investigator decides if initial R-CHOP is needed based on patient*s conditions
- Age 18-70 years
- ECOG performance status 0-3
- written informed consent
- Other lymphoma categories other than diffuse large B-cell lymphoma. In particular, patients with primary mediastinal lymphoma, intravascular large B-cell lymphoma or leg-type large B-cell lymphoma are excluded.
- Patients with positive flow cytometry examination of the CSF, but negative results in CSF conventional cytology, and without any other evidence of CNS disease.
- Patients with exclusive CNS disease at presentation (primary CNS lymphoma) are excluded
- Previous treatment with support of autologous or allogeneic stem cells/bone marrow transplantation.
- 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)
- Any other serious medical condition which could impair the ability of the patient to participate in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1-year progression-free survival (PFS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>a. Complete remission rate before autologous stem cell transplantation<br /><br>b. Response duration<br /><br>c. Overall survival<br /><br>d. Safety</p><br>