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

JRCT ID: jRCT2021200043

Registered date:31/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Previously untreated, CD20-positive follicular lymphoma
• Date of first enrollment: 20/05/2021
• Target sample size: 44
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Overall response rate(ORR) at the completion of induction therapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Okugaito Izumi