Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
every 4 weeks
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
RECRUITINGKyusyu University Hospital
Fukuoka, Fukuoka, Japan
RECRUITINGObjective response rate (ORR) (Centralized assessment)
Time frame: up to 4 years
Objective response rate (ORR) (site investigator assessment)
Time frame: up to 4 years
Overall survival (OS)
Time frame: up to 4 years
Progression free survival (PFS)
Time frame: up to 4 years
Disease control rate (DCR)
Time frame: up to 4 years
Duration of response (DOR)
Time frame: up to 4 years
Time to response (TTR)
Time frame: up to 4 years
Best overall response (BOR)
Time frame: up to 4 years
Change rate from baseline in the sum of diameters (SPD) of target lesions
Time frame: up to 4 years
Best change rate from baseline in the sum of diameters (SPD) of target lesions
Time frame: up to 4 years
Improvement rate of B symptom
Time frame: up to 4 years
Safety (Adverse event)
Time frame: Up to 30 days after the last dose
North America Clinical Trial Support Desk
CONTACT
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Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
RECRUITINGKyoto University Hospital
Kyoto, Kyoto, Japan
RECRUITINGTohoku University Hospital
Sendai, Miyagi, Japan
RECRUITINGNiigata University Medical & Dental Hospital
Niigata, Niigata, Japan
RECRUITINGKindai University Hospital
Ōsaka-sayama, Osaka, Japan
RECRUITINGTokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku, Tokyo, Japan
RECRUITINGNational Cancer Center Hospital
Chuo Ku, Tokyo, Japan
RECRUITING