None listed
Conditions
Interventions
Drug, Procedure/Surgery : This test is an open type multicenter study. Among the newly diagnosed DLBCL(Diffuse Large B cell Lymphoma) patients who were not previously treated, those with CNS(Central N
Sponsors
Chonnam National University Hospital Hwasun Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Aged =18 years 1 extranodal sites plus an elevated LDH iii) involvement of high-risk locations including bone marrow, nasal or paranasal sinuses, testis, epidural disease (paravertebral or vertebra), breast, liver, adrenal or kidney • Estimated life expectancy of more than 3 months • ECOG performance status of 2 or lower, Karnofsky scale > 60 • Adequate cardiac function (EF>45%) on echocardiogram or Heart scan (MUGA scan) • 80 years of age and over or patient who could be not treated with conventional treatment due to poor general condition.
Exclusion criteria
Exclusion criteria: • Prior chemotherapy treatment for other previous cancer • Evidence of CNS involvement at baseline: presented with primary DLBCL of CNS, or concurrent CNS and systemic involvement by DLBCL at diagnosis • Lymphoma in patients with human immunodeficiency virus • Presence of significant uncontrolled active infection or HBV/HCV carrier patients • Presence of uncontrolled bleeding • Pregnant or lactating women • Patients taking monoamine oxidase inhibitors (MAOIs) will be excluded from the study, because of the risk of severe drug interactions • Any coexisting major illness or organ failure • Have any acute, subacute or chronic peripheral nerve or spinal cord in grade, at the time of inclusion, greater than or equal to 2 (NCI CTCAE v4.0). • Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Previously untreated CNS relapsed high-risk DLBCL patients received intrathecal methotrexate (ITMTX, group A) and intravenous methotrexate (IVMTX, group B) as CNS prophylaxis with RCHOP 6 cycles CNS cumulative recurrence rate at 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival;safety | — |
Countries
Korea, Republic of
Contacts
Public ContactHwan Yang
Chonnam National University Hospital Hwasun Hospital
Outcome results
None listed