A multi institutional phase II study of oral fludarabine and rituximab (F-R therapy) for patients with relapsed or refractory mantle cell lymphoma.
- Conditions
- Mantle cell lymphoma
- Registration Number
- JPRN-UMIN000001416
- Lead Sponsor
- Hematological Malignancy Clinical Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Not provided
(1) Documented infection including viral infection (2) Sever comorbidity such as hear failure, hepatic failure or kidney failure (3) Serious GI tract symptoms such as severe nausea, vomiting or diarrhea (4) Positive test for HBs antigen (5) Positive test for HCV antibody (6) Positive test for HIV antibody (7) Serious bleeding tendency such as DIC (8) CNS involvement (9) Non-tumor fever (>38.0 C) (10) Interstitial pneumonitis or pulmonary fibrosis (11) Active double cancer that needs therapy (12) Autoimmune hemolytic anemia (AIHA) or previous history with AIHA (13) Administration of G-CSF or blood transfusion within one week before enrollment (14) Use of un-approved medicine within 3 months before enrollment (15) Previous history of fludarabine (16) Allergic reaction to purine nucleoside analogues (17) Serious hypersensitivity or anaphylaxis to rituximab or mouse protein containing products (18) History of allogeneic hematopoietic stem cell transplantation (19) History of monoclonal antibody therapy other than rituximab or ibritumomab tiuxetan (20) Pregnant, possible pregnant, or lactating women (21) Refusal to contraception (22) Other ineligibilities to this study judged by doctor in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method