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Japanese phase III study of IDEC-C2B8-SC for previously untreated B cell Follicular lymphoma.

Japanese phase III study of IDEC-C2B8-SC for previously untreated B cell Follicular lymphoma. - IDEC-C2B8-SC1

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2021200043
Enrollment
44
Registered
2021-03-31
Start date
2021-05-20
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

Previously untreated, CD20-positive follicular lymphoma

Interventions

Intravenous or subcutaneous rituximab CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone)

Sponsors

Okugaito Izumi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese patients with follicular lymphoma grade 1, 2, or 3a , according to the WHO classification system (2017) 2. No prior follwing treatment for non-Hodgkin lymphoma : chemotherapy, antibody therapy, immunosuppressive chemotherapy, radioimmunotherapy, hematopoietic stem-cell transplantation 3. Patients with at least one of GELF criteria 4. ECOG performance status of 0-2 5. Age 20 years or more, but age 80 years or younger at the time of informed consent 6. Life expectancy of 6 months or more 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Histologically proven transformation after the diagnosis of follicular lymphoma grade 1, 2 or 3a 2. Patients with HIV antibody. Patients with active hepatitis infection. One or more positive test results for HBs antigen, HBs antibody, HBc antibody or HCV antibody. 3. Patients with diabete treating with insulin 4. Patients with active multiple cancer 5. Patients with severe heart disease or lung disease 6. CNS involvement of lymphoma 7. Patients with severe psychological conditions 8. Pregnancy or nursing females

Design outcomes

Primary

MeasureTime frame
Overall response rate(ORR) at the completion of induction therapy

Contacts

Public ContactIzumi Okugaito

Zenyaku Kogyo Co.,Ltd

gcpjimukyoku@mail.zenyaku.co.jp+81-3-3946-1113

Outcome results

None listed

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