NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2021200043

Registered date:31/03/2021

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedPreviously untreated, CD20-positive follicular lymphoma
Date of first enrollment20/05/2021
Target sample size44
Countries of recruitment
Study typeInterventional
Intervention(s)Intravenous or subcutaneous rituximab CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone)

Outcome(s)

Primary OutcomeOverall response rate(ORR) at the completion of induction therapy
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Izumi Okugaito
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650, Japan Tokyo Japan 112-8650
Telephone +81-3-3946-1113
E-mail gcpjimukyoku@mail.zenyaku.co.jp
Affiliation Zenyaku Kogyo Co.,Ltd
Scientific contact
Name Izumi Okugaito
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650, Japan Tokyo Japan 112-8650
Telephone +81-3-3946-1113
E-mail gcpjimukyoku@mail.zenyaku.co.jp
Affiliation Zenyaku Kogyo Co.,Ltd