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The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in participants with relapsed or refractory T-cell lymphomas in Japan (GOLSEEK-3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of BMS-986369 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986369 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Phase 1 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with treatment-emergent adverse events (TEAEs) | Phase 1 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with Dose-Limiting Toxicity (DLT) | Phase 1 participants | Up to 28 days after first dose |
| Number of participants with laboratory abnormalities | Phase 1 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with vital sign abnormalities | Phase 1 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with Electrocardiogram (ECG) abnormalities | Phase 1 participants | Up to 5 weeks after last dose of treatment |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | Phase 1 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to Day 8 of Cycle 2 (each cycle is 28 days) | |
| Area under the plasma concentration time-curve (AUC) | Up to Day 8 of Cycle 2 (each cycle is 28 days) |
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Inclusion Criteria
- Have one of the following subtypes of T-cell Lymphoma (TCL) with relapsed or refractory disease, as assessed by the investigator:.
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).
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0031 | Anjo-shi | Aichi-ken | 446-8602 | Japan | ||
| Local Institution - 0011 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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Phase 1 participants
| Up to 5 weeks after last dose of treatment |
| Number of participants with Physical Examination (PE) abnormalities | Phase 1 participants | Up to 5 weeks after last dose of treatment |
| Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL | Phase 2: Adult T-cell Leukemia-Lymphoma (ATL) cohort OR is defined as the achievement of Partial Response (PR), complete response unconfirmed (CRu), or Complete Response (CR) | Up to 2 years after last does of treatment |
| Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based) | Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort OR is defined as the achievement of PR or CR | Up to 2 years after last dose of treatment |
| Time to peak (maximum) plasma concentration (Tmax) | Up to Day 8 of Cycle 2 (each cycle is 28 days) |
| Number of participants with AEs | Phase 2 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with TEAEs | Phase 2 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with laboratory abnormalities | Phase 2 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with vital sign abnormalities | Phase 2 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with ECG abnormalities | Phase 2 participants | Up to 5 weeks after last dose of treatment |
| ECOG PS | Phase 2 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with LVEF assessment abnormalities | Phase 2 participants | Up to 5 weeks after last dose of treatment |
| Number of participants with PE abnormalities | Phase 2 participants | Up to 5 weeks after last dose of treatment |
| Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL | ATL participants OR is defined as the achievement of PR, CRu, or CR | Up to 4 years after last dose of treatment |
| Number of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL | ATL participants OR is defined as the achievement of PR, CRu, or CR | Up to 4 years after last dose of treatment |
| Number of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based). | PTCL participants OR is defined as the achievement of PR or CR | Up to 4 years after last dose of treatment |
| Number of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based). | PTCL participants OR is defined as the achievement of PR or CR | Up to 4 years after last dose of treatment |
| Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL | ATL participants Disease control is considered to be stable disease (SD), PR, CRu, or CR | Up to 4 years after last dose of treatment |
| Number of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL | ATL participants Disease control is considered to be SD, PR, CRu, or CR | Up to 4 years after last dose of treatment |
| Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL | ATL participants | Up to 4 years after last dose of treatment |
| Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL | ATL participants | Up to 4 years after last dose of treatment |
| Time to response (TTR) as assessed by central review per international consensus response criteria for ATL | ATL participants | Up to 4 years after last dose of treatment |
| TTR as assessed by investigator per international consensus response criteria for ATL | ATL participants | Up to 4 years after last dose of treatment |
| Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL | ATL Participants | Up to 4 years after last dose of treatment |
| DOR as assessed by investigator per international consensus response criteria for ATL | ATL Participants | Up to 4 years after last dose of treatment |
| Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL | ATL participants | Up to 4 years after last dose of treatment |
| PFS as assessed by investigator per international consensus response criteria for ATL | ATL participants | Up to 4 years after last dose of treatment |
| Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants Disease control is considered to be SD, PR or CR | Up to 4 years after last dose of treatment |
| Number of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants Disease control is considered to be SD, PR or CR | Up to 4 years after last dose of treatment |
| Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants | Up to 4 years after last dose of treatment |
| Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants | Up to 4 years after last dose of treatment |
| TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants | Up to 4 years after last dose of treatment |
| TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants | Up to 4 years after last dose of treatment |
| DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants | Up to 4 years after last dose of treatment |
| DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants | Up to 4 years after last dose of treatment |
| PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants | Up to 4 years after last dose of treatment |
| PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | PTCL participants | Up to 4 years after last dose of treatment |
| Time to next treatment (TTNT) | From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, time to next treatment or the end of the trial, whichever occurs first, assessed up to 2 years after end of treatment. |
| Overall survival (OS) | From the date of last dose until the date of death, lost to follow-up, withdrawal of consent from the entire study, or the end of the trial, whichever occurs first, assessed up to 2 years after end of treatment. |
| Nagoya |
| Aichi-ken |
| 467-8602 |
| Japan |
| Local Institution - 0024 | Toyohashi | Aichi-ken | 441-8570 | Japan |
| Local Institution - 0017 | Kamogawa | Chiba | 296-0041 | Japan |
| Local Institution - 0002 | Kashiwa | Chiba | 277-8577 | Japan |
| Local Institution - 0037 | Narita | Chiba | 286-8520 | Japan |
| Local Institution - 0016 | Iizuka | Fukuoka | 820-8505 | Japan |
| Local Institution - 0041 | Kitakyushu-shi | Fukuoka | 806-8501 | Japan |
| Local Institution - 0036 | Sapporo | Hokkaido | 0608648 | Japan |
| Local Institution - 0032 | Amagasaki | Hyōgo | 660-8550 | Japan |
| Local Institution - 0033 | Kobe | Hyōgo | 650-0047 | Japan |
| Local Institution - 0004 | Isehara | Kanagawa | 259-1193 | Japan |
| Local Institution - 0013 | Yokosuka | Kanagawa | 238-8558 | Japan |
| Local Institution - 0001 | Sendai | Miyagi | 980-8574 | Japan |
| Local Institution - 0019 | Ōmura | Nagasaki | 8568562 | Japan |
| Local Institution - 0028 | Sasebo | Nagasaki | 857-8511 | Japan |
| Local Institution - 0005 | Ōsaka-sayama | Osaka | 589-8511 | Japan |
| Local Institution - 0009 | Hidaka | Saitama | 350-1298 | Japan |
| Local Institution - 0003 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Local Institution - 0029 | Itabashiku | Tokyo | 173-8610 | Japan |
| Local Institution - 0040 | Koto | Tokyo | 135-8550 | Japan |
| Local Institution - 0026 | Minato-ku | Tokyo | 105-8471 | Japan |
| Local Institution - 0018 | Fukuoka | 810-8563 | Japan |
| Local Institution - 0012 | Fukuoka | 812-8582 | Japan |
| Local Institution - 0023 | Fukuoka | 814-0180 | Japan |
| Local Institution - 0039 | Hiroshima | 730-0052 | Japan |
| Local Institution - 0025 | Hiroshima | 7348551 | Japan |
| Local Institution - 0015 | Kagoshima | 890-0064 | Japan |
| Local Institution - 0008 | Kagoshima | 890-8520 | Japan |
| Local Institution - 0035 | Kumamoto | 860-0008 | Japan |
| Local Institution - 0006 | Kumamoto | 860-8556 | Japan |
| Local Institution - 0027 | Kyoto | 602-8566 | Japan |
| Local Institution - 0022 | Mitaka | 181-8611 | Japan |
| Local Institution - 0038 | Miyazaki | 889-1692 | Japan |
| Local Institution - 0030 | Nagasaki | 852-8104 | Japan |
| Local Institution - 0007 | Okayama | 700-8558 | Japan |
| Local Institution - 0042 | Okinawa | 904-2142 | Japan |
| Local Institution - 0010 | Osaka | 541-8567 | Japan |
| Local Institution - 0034 | Osaka | 545-8586 | Japan |
| Local Institution - 0020 | Ōita | 870-8511 | Japan |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016399 | Lymphoma, T-Cell |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D015459 | Leukemia-Lymphoma, Adult T-Cell |
| D008223 | Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D007119 | Immunoblastic Lymphadenopathy |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D009182 | Mycosis Fungoides |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D000072281 | Lymphadenopathy |
| D016410 | Lymphoma, T-Cell, Cutaneous |
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