A phase II study of the Cladribine and Rituximab combination therapy for relapsed and refractory indolent B-cell Non-Hodgkin's Lymphoma.

UMIN ID: UMIN000001570

Registered date:18/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: low grade B cell lymphoma
• Date of first enrollment: 2004/11/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Cladribine 0.09mg/kg (day1-5) combined with Rituximab 375mg/m2 (day 1 and 15) is administrated every 4 weeks (total 4 cycles).

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: complete response rate, 2 years progression free survival, 2 years overall survival, time to best response, duration of remission, safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1.previous exposures of cladribine, fludarabine, or pentostatin. 2.treatment histories of more than one allogenic stem cell transplantasion or more than 2 times of autologous stem cell transplantation. 3.transformed case at registration. 4.past history of glaucoma. 5.presence of active infection. 6.HBs Ag posivtive, HCV Ab positive, HIV Ab positive. 7.presence of lymphoma cells more than 5000/mm3 in periperal blood. 8.past history of severe drug allergy. 9.presence of other active malignancy. 10.diabetis melitus recieving insulin therapy. 11.severe mental disorder. 12.autoimmune hemolytic anemia. 13.severe bleeding tendency. 14.recieving CSF or blood transfusion within 2 weeks of registration. 15.presence of central nervous involvement (clinical or pathological). 16.pregnant or feeding female. 17.recieving unapproved anti cancer agents within 3 months of registration. 18.judged for inappropriate by other reasons.

Related Information

• Primary Sponsor: refractory lymphoma treatment study group
• Source(s) of Monetary Support: none