Large B-cell Lymphoma
Conditions
Keywords
Lymphoma, Large B-Cell, Lymphoma, BMS-986369, CC-99282, DLBCL
Brief summary
The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).
Interventions
DRUGDoxorubicin
Specified dose on specified days
DRUGVincristine
Specified dose on specified days
DRUGPrednisone
Specified dose on specified days
DRUGRituximab
Specified dose on specified days
DRUGCyclophosphamide
Specified dose on specified days
DRUGGolcadomide
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including: i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified \[including germinal center B-cell (GCB) and activated B-cell (ABC) types\] ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas) iii) High-grade B-cell lymphoma, not otherwise specified iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL) v) Epstein-Barr virus + DLBCL * International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) \> 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3. * Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification. * Must have Ann Arbor Stage II-IV disease.
Exclusion criteria
* Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. * Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma. * Documented or suspected central nervous system (CNS) involvement by lymphoma. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) assessed by the Investigator | Up to approximately 67 months |
Secondary
| Measure | Time frame |
|---|---|
| PFS assessed by the Investigator | Up to approximately 67 months |
| Overall survival (OS) | Up to approximately 67 months |
| Event-free survival (EFS) | Up to approximately 67 months |
| Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC) | Up to approximately 18 weeks |
| Minimal residual disease (MRD) negativity rate | Up to approximately 18 weeks |
| Progression-free survival (PFS) assessed by the IRAC | Up to approximately 47 months |
| Objective response (OR) assessed by the Investigator | Up to approximately 18 weeks |
| Complete metabolic response (CMR) assessed by the Investigator | Up to approximately 18 weeks |
| PFS24 assessed by the Investigator 24 months after randomization | Up to 24 months |
| Duration of response (DoR) | Up to approximately 67 months |
| Second progression-free survival (PFS2) assessed by the Investigator | Up to approximately 67 months |
| Relative dose intensity (%) | Up to 18 weeks |
| Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire | Up to approximately 67 months |
| Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire | Up to approximately 67 months |
| Mean change from baseline in the EORTC QLQ-C30 | Up to approximately 67 months |
| Mean change from baseline in the FACT-LymS | Up to approximately 67 months |
| Number of participants with Adverse Events (AEs) | Up to approximately 20 weeks |
| Number of participants with treatment-emergent adverse events (TEAEs) | Up to approximately 20 weeks |
| Number of participants with laboratory abnormalities | Up to approximately 20 weeks |
| Number of participants with vital sign abnormalities | Up to approximately 20 weeks |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed