Spots Global Cancer Trial Database for Study of Blinatumomab in Japanese Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Study of Blinatumomab in Japanese Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Official Title: A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Horai Study)
Study ID: NCT02412306
Interventions
Study Description
Brief Summary: This is an open-label, combined 2-part multicenter study to evaluate the efficacy, safety, and tolerability of blinatumomab in adult and pediatric Japanese patients with relapsed/refractory B-precursor ALL.
Detailed Description: The Phase 1b part will investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of blinatumomab to determine the maximum tolerated dose (MTD) in both adult and pediatric Japanese patients with relapsed/refractory B-precursor ALL. The Phase 2 part will assess the safety and efficacy of the recommended dose level of blinatumomab identified in the Phase 1b portion of the study in the adult study population. In June 2017 protocol amendment 4 extended the study to include an expansion cohort of approximately 65 participants to investigate the safety of blinatumomab in participants who did not participate in Phase 1b or Phase 2 of the study. Adult and pediatric patients in the expansion cohort may receive up to 5 cycles of investigational blinatomumab and may receive commercial blinatomumab after a minimum of 2 cycles of the investigational drug.
Keywords
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Hospital Organization Nagoya Medical Center, Nagoya-shi, Aichi, Japan
Nagoya University Hospital, Nagoya-shi, Aichi, Japan
Kyushu University Hospital, Fukuoka-shi, Fukuoka, Japan
Gunmaken Saiseikai Maebashi Hospital, Maebashi-shi, Gunma, Japan
Sapporo Hokuyu Hospital, Sapporo-shi, Hokkaido, Japan
Kobe University Hospital, Kobe-shi, Hyogo, Japan
Kanagawa Childrens Medical Center, Yokohama-shi, Kanagawa, Japan
Nagasaki University Hospital, Nagasaki-shi, Nagasaki, Japan
Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan
Okayama University Hospital, Okayama-shi, Okayama, Japan
Osaka City General Hospital, Osaka-shi, Osaka, Japan
Osaka Metropolitan University Hospital, Osaka-shi, Osaka, Japan
Saitama Childrens Medical Center, Saitama-shi, Saitama, Japan
Jichi Medical University Hospital, Shimotsuke-shi, Tochigi, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
National Center for Child Health and Development, Setagaya-ku, Tokyo, Japan
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
