A phase II study of the combination of Rituximab, Mitoxantrone, Etoposide, and Prednisolone for relapsed elderly patients with diffuse large B-cell lymphoma (R-MEP07)

UMIN ID: UMIN000001050

Registered date:01/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Diffuse large B-cell lymphoma
• Date of first enrollment: 2007/12/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): R-MEP therapy: rituximab (375mg/m2) on day1 iv, mitoxantrone (6mg/m2) on day2 iv, etoposide (80mg/m2) on day2-6 po and prednisolone (40mg/m2) on day2-6 po. The R-MEP is repeated every 3 weeks for total four cycles.

Outcome(s)

• Primary Outcome: Overall tumor response
• Secondary Outcome: Complete response, three-year overall survival, three-year progression free survival, treatment related toxicity.

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1) CNS involvement 2) History of glaucoma 3) History of severe drug allergy 4) Active infectious diseases 5) HIV or HTLV-1 positive 6) HBs antigen or HCV antibody positive 7) Significant complications which include cardiac dysfunction, liver cirrhosis, uncontrolled diabetes, renal failure 8) Interstitial pneumonitis or fibrosis 9) History of other active malignancy 10) Severe mental disorder 11) Regular use of systemic steroids 12) Inadequate physical condition, as diagnosed by primary physician

Related Information

• Primary Sponsor: Clinical Hematology Study Group of National Hospital Organization (CHSG-NHO)
• Source(s) of Monetary Support: National Hospital Organization