JPRN-UMIN000009243CompletedPhase 2
A randomized phase2 study of bendamustine plus Rituximab for relapsing or refractory follicular lymphoma comparing 90 mg/sqm BR vs. 120 mg/sqm BR. - JYCSG NHL01 study
Juntendo, Yamanashi Clinical Study Group0 sites36 target enrollmentStarted: December 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 80years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1 Pregnant women or nursing mothers. In postmenopausal women within a year. Women and men who cannot prevent pregnancy or do not have intension to prevent during the treatment period 2 With active double cancer (synchronous double cancer or metachronous double cancer which have 5-years of disease-free, except for basal cell carcinoma, squamous cell carcinoma, carcinoma in situ which goes into remission by topical treatment, or lesion part equivalent to intramucosal carcinoma.) 3 With mental disease or neurologic manifestation considered to be difficult to participate in this study. 4 HBV-DNA positive. HIV antibody-positive. HCV antibody-positive. 5 Patients have much tumor cell in peripheral blood (>=25,000/microL). 6 Having received hematopoietic stem cell transplantation. 7 With interstitial pneumonia, radiation pneumonia, or pulmonary fibrosis on the chest CT scan (within 3-months before registration). 8 With CNS infiltration. 9 Have experience with bendamustine treatment or diagnosed unsuitable for bendamustine treatment. 10 With severe drug hypersensitivity. 11 Judged as inappropriate for this study by the investigator.
Investigators
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