A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse. - A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.

Department of Hematology and Oncology, Osaka University Graduate School of Medicine0 sites100 target enrollmentMarch 28, 2014

ConditionsDiffuse large B-cell lymphoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Diffuse large B-cell lymphoma
Sponsor: Department of Hematology and Oncology, Osaka University Graduate School of Medicine
Enrollment: 100
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 28, 2014

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Department of Hematology and Oncology, Osaka University Graduate School of Medicine

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\. Primary CNS lymphoma (include intraocular lymphoma) or lymphoma with cns involvement on CT and/or MRI, or CSF examination on admission 2\. Intravascular lymphoma, primary effusion lymphoma, mediastinal large B\-cell lymphoma 3\. Primary testicular lymphoma 4\. Patients with peripheral bood involvement of lymphoma on admission 5\. Prior treatment for lymphoma except lymph node biopsy and local radiation therapy 6\. Presence of fluid in the third space (e.g. pleural effusions) 7\. Patients with pre\-existing renal insufficiency 8\. Patients with another active malignancy 9\. Patients with serious complications (malignant hypertension, congestive heart failure, coronary insufficiency, a new onset of myocardial infarction within 3 months, uncontrolled hyperglycemia, pulmonary fibrosis, interstitial pneumonia, etc) 10\. Severe psychosis 11\. Presence of uncontrollable active infection 12\. Patients with allergy to drug used for conditioning regimen 13\. Positive for HIV antibody, HCV antibody or HTLV\-1 antibody 14\. HBs antigen positive patients judged unfeasible to participate in this protocol in spite of the administration of antiviral drugs 15\. Patients who are pregnant or lactating 16\. Without any written consent from patients 17\. Inadequate patients to enroll judged by investigators

Outcomes

Primary Outcomes

Not specified

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