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) studied | Mantle cell lymphoma |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Chemotherapy (6 cycles of F-R therapy) |
Outcome(s)
| Primary Outcome | Overall response rate (ORR) |
|---|---|
| Secondary Outcome | Complete response rate(%CR), progression-free survival (PFS), overall survival (OS), response rate with PET/CT scan |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 79years-old |
| Gender | Male 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
| Primary Sponsor | Hematological Malignancy Clinical Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| 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 |
| Telephone | |
| Affiliation | Nagoya Daini Red Cross Hospital Department of Hematology & Oncology |