Estudio de fase 3, multicéntrico, aleatorizado, doble cie... | EligiMed

Estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo, que compara la eficacia y seguridad de golcadomida más quimioterapia R-CHOP versus placebo más quimioterapia R-CHOP en participantes con linfoma de células B grandes de alto riesgo no tratado previamente (GOLSEEK-1)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06356129Tipo: INTERVENTIONALInicio: 19 de jun de 2024Fin estimado: 20 de nov de 2029

Resumen

El propósito de este estudio es comparar la efectividad y seguridad de golcadomida en combinación con quimioterapia de rituximab, ciclofosfamida, doxorrubicina, vincristina y prednisona (R-CHOP) versus placebo en combinación con quimioterapia R-CHOP en participantes con linfoma de células B grandes (LCBG) de alto riesgo no tratado previamente.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

\- 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.

Criterios de exclusión

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.