A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide)… (NCT06035497) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
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)
Japan85 participantsStarted 2023-11-20
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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).
* 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 pa…
What they're measuring
1
Number of participants with Adverse Events (AEs)
Timeframe: Up to 5 weeks after last dose of treatment
2
Number of participants with treatment-emergent adverse events (TEAEs)
Timeframe: Up to 5 weeks after last dose of treatment
3
Number of participants with Dose-Limiting Toxicity (DLT)
Timeframe: Up to 28 days after first dose
4
Number of participants with laboratory abnormalities
Timeframe: Up to 5 weeks after last dose of treatment
5
Number of participants with vital sign abnormalities
Timeframe: Up to 5 weeks after last dose of treatment
6
Number of participants with Electrocardiogram (ECG) abnormalities
Timeframe: Up to 5 weeks after last dose of treatment
7
Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Timeframe: Up to 5 weeks after last dose of treatment
8
Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities
Timeframe: Up to 5 weeks after last dose of treatment
9
Number of participants with Physical Examination (PE) abnormalities
Timeframe: Up to 5 weeks after last dose of treatment
10
Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL
Timeframe: Up to 2 years after last does of treatment
11
Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based)
Timeframe: Up to 2 years after last dose of treatment