A Phase 3, Open-Label, Randomized Study To Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, Combined with Chemotherapy versus Rituximab Combined with Chemotherapy in Previously Untreated Participants with Follicular Lymphoma (OLYMPIA-2)
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Coagulopatías hemorrágicas, Leucemia mieloide aguda, Terapia celular y T-CARs, Trasplante de progenitores hematopoyéticos, Linfoma Folicular, Linfoma
CENTRO INVESTIGADOR
H. Fundación Jiménez Díaz
INVESTIGADOR PRINCIPAL
Raúl Córdoba Mascuñano
CENTRO INVESTIGADOR
H.U. Infanta Leonor
INVESTIGADOR PRINCIPAL
José Ángel Hernández Rivas
CENTRO INVESTIGADOR
H.U. Quirónsalud Madrid
INVESTIGADOR PRINCIPAL
Maria Aránzazu Alonso Alonso
CENTRO INVESTIGADOR
H.U. 12 de Octubre
INVESTIGADOR PRINCIPAL
Ana Isabel Jiménez Ubieto
CENTRO INVESTIGADOR
H.U. Ramón y Cajal
INVESTIGADOR PRINCIPAL
Francisco Javier López Jiménez
FECHA DE APERTURA
Ocutbre, 2023
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate bone marrow and hepatic function
NOTE: Other protocol defined inclusion criteria apply
Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate bone marrow and hepatic function
NOTE: Other protocol defined inclusion criteria apply
CRITERIOS DE EXCLUSIÓN
Participants with central nervous system lymphoma or leptomeningeal lymphoma
Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
Recent major surgery and history or organ transplantation
A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol
NOTE: Other protocol defined exclusion criteria apply
Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
Recent major surgery and history or organ transplantation
A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol
NOTE: Other protocol defined exclusion criteria apply
DESCRIPCIÓN
Part 1 Assess the safety, tolerability, and dose limiting toxicities (DLTs) of odronextamab in combination with chemotherapy in participants with previously untreated follicular lymphoma (FL) and participants with relapsed or refractory (R/R) FL (Part 1A only), and to determine an optimal dosing regimen of odronextamab (Part 1B) in previously untreated participants with FL to combine with CHOP/CVP in Part 2. Part 2 To compare the efficacy of odronextamab in combination with chemotherapy versus rituximab in combination with chemotherapy in participants with previously untreated FL as measured by complete response rate at 30 months (CR30) per independent central review.
PALABRAS CLAVE
bispecific antibody, cd20, donor lymphocyte infusion, factor xi, follicular lymphoma, lymphoma, ph + acute lymphoblastic leukemia
