Spots Global Cancer Trial Database for Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
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Trial Identification
Brief Title: Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
Official Title: Randomized Phase 3 Study Evaluation the Efficacy and Safety of Oral Azacitidine(CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
Study ID: NCT03703375
Conditions
Study Description
Brief Summary: This study is a multicentric, open-label, randomized phase 3 trial. The study will be conducted in select countries in Europe and South Korea sponsored by LYSARC and in Japan sponsored by Celgene. There will be a combined enrollment target of 86 randomized patients, with approximately 14 randomized patients from Japan. The enrollment to the randomized study will start at European sites in parallel to a safety run-in part in Japan. A safety run-in will be conducted to confirm the tolerability of oral azacitidine at doses of 100 mg and 200 mg QD in Asian patients. Once oral azacitidine at 200 mg QD is confirmed as tolerable, Asian patients from Japan and South Korea will start to be randomized into the main study. Additional patients (non-randomized) are anticipated to enroll to the safety run-in.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 41922, Okayama-shi, Okayama, Japan
Local Institution - 41722, Osakasayama, Osaka, Japan
Local Institution - 41422, Hidaka, Saitama, Japan
Local Institution - 40722, Chuo-ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Saitama Medical University International Medical Center, Hidaka, , Japan
Tokai University Hospital, Isehara City, Kanagawa, , Japan
Local Institution - 41522, Kashiwa, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
Local Institution - 40222, Koto-ku, , Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Koto-ku, , Japan
Local Institution - 41622, Nagoya-shi, , Japan
National Hospital Organization - Nagoya Medical Center, Nagoya-shi, , Japan
Okayama University Hospital, Okayama, , Japan
Kindai University Hospital, Osaka-Sayama, , Japan
Hokkaido University Hospital, Sapporo, Hokkaidô, , Japan
Local Institution - 41822, Sapporo, Hokkaidô, , Japan
Tohoku University Hospital, Sendai, , Japan
Local Institution - 41322, Tsukuba, , Japan
University of Tsukuba Hospital, Tsukuba, , Japan
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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