NIPH Clinical Trials Search

UMIN ID: UMIN000001416

Registered date:11/10/2008

A multi institutional phase II study of oral fludarabine and rituximab (F-R therapy) for patients with relapsed or refractory mantle cell lymphoma.

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedMantle cell lymphoma
Date of first enrollment2008/10/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Chemotherapy (6 cycles of F-R therapy)


Primary OutcomeOverall response rate (ORR)
Secondary OutcomeComplete response rate(%CR), progression-free survival (PFS), overall survival (OS), response rate with PET/CT scan

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum79years-old
GenderMale and Female
Include criteria
Exclude criteria(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

Related Information


public contact
Address Japan
Telephone 052-832-1121
Affiliation Hematological Malignancy Clinical Study Group Hematological Malignancy Clinical Study Group
scientific contact
Name Michinori Ogura
Address Myokencho 2-9, Showaku, Nagoya Japan
Affiliation Nagoya Daini Red Cross Hospital Department of Hematology & Oncology