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Phase II study of bendamustine, rituximab and cytarabine for patients with relapsed or refractory follicular lymphoma or mantle cell lymphoma

Phase 2
Conditions
relapsed or refractory follicular lymphoma or mantle cell lymphoma
Registration Number
JPRN-UMIN000009797
Lead Sponsor
Gifu University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
13
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients are pregnant or lactating women. Patients (<1 year after menopause without surgical infertility) can not or will not use birth control during the treatment. 2) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. 3) Patients have mental disease or disorder with difficulty in participating in the clinical trial. 4) HIV antibody positive, HBs antigen positive, HCV antibody positive 5) Patients have much tumor cell in peripheral blood (>=25,000/mm3). 6) Patients received allogeneic hematopoietic stem cell transplant. 7) Patients have interstitial lung disease or fibroid lung. 8) Patients have CNS invasion. 9) Patients are inappropriate for rituximab treatment. 10) Patients have severe allergic symptoms. 11) Inadequate for clinical trial entry by the attending physicians.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
complete response rate
Secondary Outcome Measures
NameTimeMethod
overall response rate event free survival progression free survival safty peripheral blood stem cell harvest (transplant case)
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