Prospective, multicenter, randomized ,open-labeled, phase III study comparing high-dose intravenous methotrexate versus intrathecal methotrexate for the prophylaxis of CNS relapse in diffuse large B cell lymphoma
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0003887
- Lead Sponsor
- Chonnam National University Hospital Hwasun Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 205
•Aged =18 years <80
•Newly diagnosed DLBCL
•High risk of CNS recurrence at diagnosis:
i)Age-adjusted IPI (aaIPI) = 2 or IPI = 4
ii)involvement of >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.
•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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 2-year progression-free survival;safety