A phase II study of the remission induction and maintenance therapy by rituximab for rituximab naive low grade B cell lymphoma.

UMIN ID: UMIN000001191

Registered date:20/06/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: low grade B cell lymphoma
• Date of first enrollment: 2005/12/01
• Target sample size: 42
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The remission induction therapy with weekly 8 doses of rituximab(375mg/m2) followed by the 4 courses of every 6 months maintenance therapy with weekly 4 doses of rituximab(375mg/m2).

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: complete response rate, 3 years over all survival, safety, 3 years progression free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1.presence of central nervous invasion(clinical or pathological). 2.transformed patients (clinical or pathological). 3.past history of glaucoma. 4.past history of severe drug allergy. 5.HIV Ab positive or HTLV-1 Ab positive. 6.HBsAg positive, HBsAb positive, or HCV Ab positive. 7.severe cardiac disease 8.hepatic cirrhosis 9.uncontrollable diabetis melitus 10.patients with dialysis 11.lung fibrosis or interstitial pneumonitis 12.other active malignancies 13.pregnant or feeding female 14.severe mental disorder 15.systemic therapy with corticosteroid 16.judged for inappropriate with other reasons.

Related Information

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