A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
NCT ID: NCT06035497
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
85 participants
INTERVENTIONAL
2023-11-20
2030-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of BMS-986369
BMS-986369
Specified dose on specified days
Interventions
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BMS-986369
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
i) Adult T-cell leukemia-lymphoma (ATL).
ii) Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).
iii) Angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper phenotype (TFH) cell origin.
iv) Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).
v) ALCL, anaplastic lymphoma kinase-negative (ALK-).
vi) Breast implant-associated ALCL.
vii) Extranodal NK/T-cell lymphoma, nasal type (ENKL).
viii) Mycosis fungoides (MF) with advanced stage (stage IIB-IVB).
* Phase 1 participants must not be responsive, intolerant, or ineligible to standard therapies that may prolong life or provide symptomatic relief, or for whom no standard therapeutic option is available in the clinical practice guidelines in the opinion of the investigator.
* Phase 2 participants must have been treated by at least 1 prior line of systemic therapy.
* Have an Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
Exclusion Criteria
* Have any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participants at unacceptable risk if he/she were to participate in the study.
* Have a life expectancy ≤ 3 months.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bistol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Anjo Kosei Hospital
Anjo-shi, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan
Kameda General Hospital
Kamogawa, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
International University of Health and Welfare Narita Hospital
Narita, Chiba, Japan
Aso Iizuka Hospital
Iizuka, Fukuoka, Japan
Japan Community Healthcare Organization Kyushu Hospital
Kitakyushu-shi, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Yokosukakyosai
Yokosuka, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan
Sasebo City General Hospital
Sasebo, Nagasaki, Japan
Kindai University Hospital- Osakasayama Campus
Ōsaka-sayama, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashiku, Tokyo, Japan
Japanese Foundation for Cancer Research
Koto, Tokyo, Japan
The Jikei University Hospital
Minato-ku, Tokyo, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Fukuoka University Hospital
Fukuoka, , Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Imamura General Hospital
Kagoshima, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Kumamoto University
Kumamoto, , Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
Kyorin University Hospital
Mitaka, , Japan
University of Miyazaki Hospital
Miyazaki, , Japan
The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, , Japan
Okayama University Hospital
Okayama, , Japan
Nakagami Hospital Okinawa
Okinawa, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Oita Prefectural Hospital
Ōita, , Japan
Countries
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Central Contacts
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First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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MASASHI SAWA, Site 0031
Role: primary
Tomoko Narita, Site 0011
Role: primary
Shingo Kurahashi, Site 0024
Role: primary
Kosei Matsue, Site 0017
Role: primary
Junichiro Yuda, Site 0002
Role: primary
Chiaki Nakaseko, Site 0037
Role: primary
Motoaki Shiratsuchi, Site 0016
Role: primary
Ryosuke Ogawa, Site 0041
Role: primary
Masao Nakagawa, Site 0036
Role: primary
Mitsumasa Watanabe, Site 0032
Role: primary
Ryusuke Yamamoto, Site 0033
Role: primary
Yoshiaki Ogawa, Site 0004
Role: primary
Shigeo Toyota, Site 0013
Role: primary
NORIKO FUKUHARA, Site 0001
Role: primary
Yoshitaka Imaizumi, Site 0019
Role: primary
Yukiyoshi Moriuchi, Site 0028
Role: primary
TAKAHIRO KUMODE, Site 0005
Role: primary
Tomoya Maeda, Site 0009
Role: primary
Koji Izutsu, Site 0003
Role: primary
Katsuhiro Miura, Site 0029
Role: primary
Dai Maruyama, Site 0040
Role: primary
Shingo Yano, Site 0026
Role: primary
Ken Takase, Site 0018
Role: primary
Kohta Miyawaki, Site 0012
Role: primary
Yasushi Takamatsu, Site 0023
Role: primary
Tsuyoshi Muta, Site 0039
Role: primary
Tatsuo Ichinohe, Site 0025
Role: primary
Yoshikiyo Ito, Site 0015
Role: primary
Kenji Ishitsuka, Site 0008
Role: primary
Toshiro Kawakita, Site 0035
Role: primary
Hiro Tatetsu, Site 0006
Role: primary
Junya Kuroda, Site 0027
Role: primary
Shunya Arai, Site 0022
Role: primary
Kazuya Shimoda, Site 0038
Role: primary
Tatsuro Jo, Site 0030
Role: primary
Keisuke Seike, Site 0007
Role: primary
Masaki Hayashi, Site 0042
Role: primary
Takafumi Yokota, Site 0010
Role: primary
Kentaro Ido, Site 0034
Role: primary
Eiichi Ohtsuka, Site 0020
Role: primary
Related Links
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BMS Clinical Trial Information
Other Identifiers
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CA073-1008
Identifier Type: -
Identifier Source: org_study_id
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