Phase II study of Bendamustine-Rituximab therapy for CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapy

Phase 2

• Conditions: untreated and advanced follicular lymphoma

• Registration Number: JPRN-UMIN000013795
• Lead Sponsor: Department of Hematology and Rheumatology,Kinki University Faculty of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-24
• Results First Posted: 2021-08-17
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1)Any other active malignancies 2)Uncontrollable serious complications (diabetes, heart failure, cardiomyopathy, abnormal heart rhythm, angina, myocardial infarction, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, infection, a respiratory failure, an organic lung disease, hepatic insufficiency, liver cirrhosis, acute chronic hepatitis, renal insufficiency, etc.) patients with active tuberculosis 3)Circulating lymphoma cells >= 25,000 /uL in peripheral blood 4)Primary central nervous system lymphoma or central nervous system invasion 5)Anaphylactic shock for any drugs 6)The HCV antibody-positive 7)Inappropriate for rituximab treatment 8)Serious mental disorder, such as schizophrenia 9)Diagnosed as a malignant lymphoma, leukemia, and myelodysplastic syndromes in the past 10)The treatment history of the chemotherapy, the radiotherapy, cytokine therapy, and antibody therapy to FL 11)Pregnant/female patients who are unwilling to take prevention measures for contraception during treatment 12)HIV antibody-positive 13)Inappropriate for entry by physician's decision

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival rate of 3 years of BR therapy enforcement group

Secondary Outcome Measures

Name	Time	Method
1) Response rate 2) Complete response rate 3)Progression free survival (the median) 4) Safety (Adverse events) 5) Convalescence prediction factor of follicular lymphoma 6) Overall survival 7) histological transformation