systemic diffuse large B-cell lymphoma with central nervous system involvement at diagnosis or relapse
Conditions
Interventions
Product Name: METROTREXATO
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methotrexate
CAS Number: 59-05-2
Current Sponsor code: PR1
Other descriptive name: METHOTREXATE
Product Nam
Sponsors
IELSG (INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of diffuse large B-cell lymphoma 2. CNS involvement (brain, meninges, cranial nerves, eyes and/or spinal cord) at diagnosis (concomitant to extra-CNS disease) or relapse after conventional chemo(-immuno)therapy 3. 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. 4. 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 5. Age 18-70 years 6. ECOG performance status 0-3 7. Adequate bone marrow (Platelets count =100.000/mm3, hemoglobin =9 g/dL, neutrophils count =1.500/mm3), renal (creatinine clearance =60 mL/min), cardiac (LVEF =50%), and hepatic function (total serum bilirubine =3 mg/dL, AST/ALT and GGT =2.5 per upper normal limit value), unless the abnormality is due to lymphoma infiltration 8. Absence of HIV infection and of detectable HCV-RNA and/or HBsAg and/or HBV-DNA 9. No concurrent malignancies. Previous malignancies are accepted if surgically cured or if there was no evidence of disease in the last 3 years at a regular follow-up 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. Given 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 any prejudice. Informed consent signed by a patient’s guardian is acceptable if the patient is not able to decide inclusion in the study due to cognitive impairment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. 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. 2. Patients with positive flow cytometry examination of the CSF, but negative results in CSF conventional cytology, and without any other evidence of CNS disease. 3. Patients with exclusive CNS disease at presentation (primary CNS lymphoma) are excluded 4. Previous treatment with support of autologous or allogeneic stem cells/bone marrow transplantation. 5. 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) 6. Any other serious medical condition which could impair the ability of the patient to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy of a new sequential combination of chemoimmunotherapy;Secondary Objective: to evaluate the tolerability of a new sequential combination of chemoimmunotherapy;Primary end point(s): 1 year Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Complete remission rate before autologous stem cell transplantation • Response duration • Overall survival (OS) • Safety;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Italy, Netherlands, Switzerland
Contacts
Public ContactIELSG Operation Office
IELSG
Outcome results
None listed