BMS-986369
DrugSpecified dose on specified days
Other names: Golcadomide, CC-99282
NCT Number: NCT06035497
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).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Local Institution - 0031, Anjo-shi, Aichi-ken, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Exclusion criteria
Specified dose on specified days
Other names: Golcadomide, CC-99282
Time frame: Up to 5 weeks after last dose of treatment
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 1 participants
Time frame: Up to 28 days after first dose
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 1 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 1 participants
Time frame: Up to 2 years after last does of treatment
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 dose of treatment
Phase 2: Peripheral T-cell Lymphoma (PTCL) cohort
OR is defined as the achievement of PR or CR
Time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
Time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
Time frame: Up to Day 8 of Cycle 2 (each cycle is 28 days)
Time frame: Up to 5 weeks after last dose of treatment
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 2 participants
Time frame: Up to 5 weeks after last dose of treatment
Phase 2 participants
Time frame: Up to 4 years after last dose of treatment
ATL participants
OR is defined as the achievement of PR, CRu, or CR
Time frame: Up to 4 years after last dose of treatment
ATL participants
OR is defined as the achievement of PR, CRu, or CR
Time frame: Up to 4 years after last dose of treatment
PTCL participants
OR is defined as the achievement of PR or CR
Time frame: Up to 4 years after last dose of treatment
PTCL participants
OR is defined as the achievement of PR or CR
Time frame: Up to 4 years after last dose of treatment
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
ATL participants
Disease control is considered to be SD, PR, CRu, or CR
Time frame: Up to 4 years after last dose of treatment
ATL participants
Time frame: Up to 4 years after last dose of treatment
ATL participants
Time frame: Up to 4 years after last dose of treatment
ATL participants
Time frame: Up to 4 years after last dose of treatment
ATL participants
Time frame: Up to 4 years after last dose of treatment
ATL Participants
Time frame: Up to 4 years after last dose of treatment
ATL Participants
Time frame: Up to 4 years after last dose of treatment
ATL participants
Time frame: Up to 4 years after last dose of treatment
ATL participants
Time frame: Up to 4 years after last dose of treatment
PTCL participants
Disease control is considered to be SD, PR or CR
Time frame: Up to 4 years after last dose of treatment
PTCL participants
Disease control is considered to be SD, PR or CR
Time frame: Up to 4 years after last dose of treatment
PTCL participants
Time frame: Up to 4 years after last dose of treatment
PTCL participants
Time frame: Up to 4 years after last dose of treatment
PTCL participants
Time frame: Up to 4 years after last dose of treatment
PTCL participants
Time frame: Up to 4 years after last dose of treatment
PTCL participants
Time frame: Up to 4 years after last dose of treatment
PTCL participants
Time frame: Up to 4 years after last dose of treatment
PTCL participants
Time frame: Up to 4 years after last dose of treatment
PTCL participants
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.
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.
Bristol-Myers Squibb
Industry
A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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