JRCT ID: jRCT1060200019
Registered date:09/10/2020
Identification of molecular biomarkers of untreated follicular lymphoma treated by GB therapy.
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Follicular lymphoma |
| Date of first enrollment | 28/01/2021 |
| Target sample size | 200 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | The rate of POD24 |
|---|---|
| Secondary Outcome | 1) 2-year PFS (Relapse free survival) 2) Overall response rate (ORR) at the end of GB therapy 3) 3-year OS (Overall survival) 4) 3-year OS (Overall survival) of the patients with POD24 |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1) Histologically proven CD20 positive follicular lymphoma (Grade 1, 2, 3A). 2) Age 70-year-old or more. 3) Treated by GB therapy as an initial therapy. 4) Written informed consent |
| Exclude criteria | Patients who refuse to participate in the study |
Related Information
| Primary Sponsor | Maeda Yoshinobu |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Chugai Pharmaceutical Co., Ltd,Nippon Shinyaku Co., Ltd |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Daisuke Ennishi |
| Address | 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan, 700-8558 Okayama Japan 700-8558 |
| Telephone | +81-86-235-7414 |
| daisukeennishi@okayama-u.ac.jp | |
| Affiliation | Center for Comprehensive Genomic Medicine, Okayama University Hospital |
| Scientific contact | |
| Name | Yoshinobu Maeda |
| Address | 2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan, 700-8558 Okayama Japan 700-8558 |
| Telephone | +81-86-235-7227 |
| yosmaeda@md.okayama-u.ac.jp | |
| Affiliation | Department of Hematology and Oncology, Okayama University Hospital |