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

Phase 2

• Conditions: low grade B cell lymphoma

• Registration Number: JPRN-UMIN000001570
• Lead Sponsor: refractory lymphoma treatment study group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-18
• Study Completion: 2010-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response rate

Secondary Outcome Measures

Name	Time	Method
complete response rate, 2 years progression free survival, 2 years overall survival, time to best response, duration of remission, safety