Relapsed or Refractory T-cell Lymphomas
Conditions
Keywords
Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL), Relapsed or Refractory Adult T-cell Leukemia/Lymphoma (R/R ATL), Golcadomide, BMS-986369, CC-99282, Adult T-cell leukemia/lymphoma (ATL), Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma and other nodal lymphomas of T follicular helper (TFH) cell origin, Angioimmunoblastic T-cell lymphoma (AITL), Follicular T-cell lymphoma (FTCL), Nodal peripheral T-cell lymphoma with TFH phenotype, Anaplastic large cell lymphoma, ALK-positive (ALCL, ALK+), Anaplastic large cell lymphoma, ALK-negative (ALCL, ALK-), Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), Extranodal NK/T-cell lymphoma, nasal type (ENKL), Mycosis fungoides (MF)
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).
Interventions
DRUGBMS-986369
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to 5 weeks after last dose of treatment | Phase 1 participants |
| Number of participants with treatment-emergent adverse events (TEAEs) | Up to 5 weeks after last dose of treatment | Phase 1 participants |
| Number of participants with Dose-Limiting Toxicity (DLT) | Up to 28 days after first dose | Phase 1 participants |
| Number of participants with laboratory abnormalities | Up to 5 weeks after last dose of treatment | Phase 1 participants |
| Number of participants with vital sign abnormalities | Up to 5 weeks after last dose of treatment | Phase 1 participants |
| Number of participants with Electrocardiogram (ECG) abnormalities | Up to 5 weeks after last dose of treatment | Phase 1 participants |
| Eastern Cooperative Oncology Group Performance Status (ECOG PS) | Up to 5 weeks after last dose of treatment | Phase 1 participants |
| Number of participants with Left Ventricular Ejection Fraction (LVEF) assessment abnormalities | Up to 5 weeks after last dose of treatment | Phase 1 participants |
| Number of participants with Physical Examination (PE) abnormalities | Up to 5 weeks after last dose of treatment | Phase 1 participants |
| Number of participants who achieve Objective Response (OR) as assessed by central review per international consensus response criteria for ATL | 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) |
| Number of participants who achieve OR as assessed by central review per protocol-defined response criteria according to Lugano classification (Computed Tomography(CT)-based) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Time to peak (maximum) plasma concentration (Tmax) | Up to Day 8 of Cycle 2 (each cycle is 28 days) | — |
| Number of participants with AEs | Up to 5 weeks after last dose of treatment | Phase 2 participants |
| Number of participants with TEAEs | Up to 5 weeks after last dose of treatment | Phase 2 participants |
| Number of participants with laboratory abnormalities | Up to 5 weeks after last dose of treatment | Phase 2 participants |
| Number of participants with vital sign abnormalities | Up to 5 weeks after last dose of treatment | Phase 2 participants |
| Number of participants with ECG abnormalities | Up to 5 weeks after last dose of treatment | Phase 2 participants |
| ECOG PS | Up to 5 weeks after last dose of treatment | Phase 2 participants |
| Number of participants with LVEF assessment abnormalities | Up to 5 weeks after last dose of treatment | Phase 2 participants |
| Number of participants with PE abnormalities | Up to 5 weeks after last dose of treatment | Phase 2 participants |
| Number of participants who achieve OR as assessed by central review per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants OR is defined as the achievement of PR, CRu, or CR |
| Number of participants who achieve OR as assessed by investigator per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants OR is defined as the achievement of PR, CRu, or CR |
| Number of participants who achieve OR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based). | Up to 4 years after last dose of treatment | PTCL participants OR is defined as the achievement of PR or CR |
| Number of participants who achieve OR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based). | Up to 4 years after last dose of treatment | PTCL participants OR is defined as the achievement of PR or CR |
| Number of participants who achieve disease control as assessed by central review per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants Disease control is considered to be stable disease (SD), PR, CRu, or CR |
| Number of participants who achieve disease control as assessed by investigator per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants Disease control is considered to be SD, PR, CRu, or CR |
| Number of participants who achieve CR as assessed by central review per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants |
| Number of participants who achieve CR as assessed by investigator per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants |
| Time to response (TTR) as assessed by central review per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants |
| TTR as assessed by investigator per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants |
| Duration of response (DOR) as assessed by central review per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL Participants |
| DOR as assessed by investigator per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL Participants |
| Progression Free Survival (PFS) as assessed by central review per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants |
| PFS as assessed by investigator per international consensus response criteria for ATL | Up to 4 years after last dose of treatment | ATL participants |
| Number of participants who achieve disease control as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants Disease control is considered to be SD, PR or CR |
| Number of participants who achieve disease control as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants Disease control is considered to be SD, PR or CR |
| Number of participants who achieve CR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants |
| Number of participants who achieve CR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants |
| TTR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants |
| TTR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants |
| DOR as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants |
| DOR as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants |
| PFS as assessed by central review per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants |
| PFS as assessed by investigator per protocol defined response criteria according to Lugano classification (CT-based) | Up to 4 years after last dose of treatment | PTCL participants |
| 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. | — |
Countries
Japan
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed