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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001416

Enrollment

Registered

2008-10-11

Start date

2008-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle cell lymphoma

Interventions

Chemotherapy (6 cycles of F-R therapy)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: (1) Pathohistological diagnosis of mantle cell lymphoma (2) Positive for cyclin D1 in cell nucleus by immunohisitochemical analysis (3) Positive for CD5 and CD20 in lymphoma cells by flowcytometry or immunohistochemistry (4) Having evaluable lesion (5) Relapsed or refractory to previous immuno-chemotherapy (6) Interval of more than 4 weeks from previous chemotherapy (7) Predictive survival time of at least 3 months (8) Age: 20-79 (9) Performance status (PS): 0-2 (10) No major organ dysfunction (11) Patient's written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR)	—

Secondary

Measure	Time frame
Complete response rate(%CR), progression-free survival (PFS), overall survival (OS), response rate with PET/CT scan	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026