Status:
RECRUITING
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)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Relapsed or Refractory T-cell Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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).
- 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 significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
- 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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2030
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06035497
Start Date
November 20 2023
End Date
October 10 2030
Last Update
May 14 2025
Active Locations (40)
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1
Anjo Kosei Hospital
Anjo-shi, Aichi-ken, Japan, 446-8602
2
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
3
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, Japan, 441-8570
4
Kameda General Hospital
Kamogawa, Chiba, Japan, 296-0041