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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Specified dose on specified days
Number of participants with Adverse Events (AEs)
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with treatment-emergent adverse events (TEAEs)
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with Dose-Limiting Toxicity (DLT)
Phase 1 participants
Time frame: Up to 28 days after first dose
Number of participants with laboratory abnormalities
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with vital sign abnormalities
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with Electrocardiogram (ECG) abnormalities
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with Physical Examination (PE) abnormalities
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CONTACT
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Anjo Kosei Hospital
Anjo-shi, Aichi-ken, Japan
RECRUITINGNagoya City University Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGToyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan
RECRUITINGKameda General Hospital
Kamogawa, Chiba, Japan
RECRUITINGNational Cancer Center Hospital East
Kashiwa, Chiba, Japan
RECRUITINGInternational University of Health and Welfare Narita Hospital
Narita, Chiba, Japan
RECRUITINGAso Iizuka Hospital
Iizuka, Fukuoka, Japan
RECRUITINGJapan Community Healthcare Organization Kyushu Hospital
Kitakyushu-shi, Fukuoka, Japan
RECRUITINGHokkaido University Hospital
Sapporo, Hokkaido, Japan
RECRUITINGHyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, Japan
RECRUITING...and 30 more locations
Phase 1 participants
Time frame: 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)
Time frame: 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
Time frame: Up to 2 years after last dose of treatment
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
Area under the plasma concentration time-curve (AUC)
Time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
Time to peak (maximum) plasma concentration (Tmax)
Time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
Number of participants with AEs
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with TEAEs
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with laboratory abnormalities
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with vital sign abnormalities
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with ECG abnormalities
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
ECOG PS
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with LVEF assessment abnormalities
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Number of participants with PE abnormalities
Phase 2 participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 4 years after last dose of treatment
TTR as assessed by investigator per international consensus response criteria for ATL
ATL participants
Time frame: 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
Time frame: Up to 4 years after last dose of treatment
DOR as assessed by investigator per international consensus response criteria for ATL
ATL Participants
Time frame: 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
Time frame: Up to 4 years after last dose of treatment
PFS as assessed by investigator per international consensus response criteria for ATL
ATL participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 4 years after last dose of treatment
Time to next treatment (TTNT)
Time frame: 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)
Time frame: 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.