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Phase II study of remission induction therapy with bendamustine and rituximab combination (BR) therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.(BRiZ2012 protocol)

Phase II study of remission induction therapy with bendamustine and rituximab combination (BR) therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.(BRiZ2012 protocol) - Phase II study of remission induction therapy with BR therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008793
Enrollment
28
Registered
2012-09-03
Start date
2012-09-01
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

follicular lymphoma

Interventions

BR therapy for 4 cycles as remission induction therapy. Ibritumomab tiuxetan therapy for the responded patients as CR, CRu, PR after BR therapy.

Sponsors

Society of Lymphoma Treatment in Japan (SoLTJ)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically confirmed CD20 positive relapsed follicular lymphoma patients within two previous chemotherapy regimens after diagnosis of the lymphoma. Aged between 20 or more to 75 or less at registration. Performance status(ECOG) : 0-2. Having measurable diseases. No serious organ damage. A life expectancy of at least 3 months. Had to give written informed consent to participate this study.

Exclusion criteria

Exclusion criteria: Histologically confirmed CD20 negative lymphoma by biopsy at the time of diagnosis or relapse. Having active double or multiple cancer. Having infectious disease with poor control (including active tuberculosis ). Having the central nervous system infiltration of the lymphoma. Intolerant to the drugs using in this study. If any of HIV antibody, HBs antigen or HCV antibody positivity. Pregnant (including possibility), nursing women. Had received bendamustine administration previously.

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS) for 2 years after the completion of ibritumomab tiuxetan therapy

Secondary

MeasureTime frame
Response rate (RR) after BR therapy Complete response rate (CRR) after BR therapy RR after ibritumomab tiuxetan therapy CRR after ibritumomab tiuxetan therapy PFS after ibritumomab tiuxetan therapy 2-year overall survival (OS) after ibritumomab tiuxetan therapy Safety

Countries

Japan

Contacts

Public ContactMasatoshi Kanno

Nara Medical University Hospital Oncology Center

mkanno@naramed-u.ac.jp0744-22-3052

Outcome results

None listed

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