Resumen

Este estudio investiga un fármaco experimental llamado odronextamab, denominado fármaco del estudio. El estudio está centrado en pacientes con linfoma B no Hodgkin agresivo previamente tratado cuyo cáncer ha dejado de responder al tratamiento (también conocido como "refractario") o ha reaparecido (también conocido como "recidivante"). El objetivo del estudio es evaluar la seguridad, tolerabilidad y eficacia del fármaco del estudio cuando se administra solo. El estudio aborda además otras preguntas de investigación, entre ellas: * Qué efectos secundarios pueden producirse con el fármaco del estudio en comparación con el estándar de atención (EOA). * Cuánto fármaco del estudio hay en la sangre en diferentes momentos. * Si el organismo produce anticuerpos contra el fármaco del estudio (lo cual podría reducir su eficacia o provocar efectos secundarios). * Comparación del impacto del fármaco del estudio versus el EOA sobre la calidad de vida y la capacidad para realizar actividades cotidianas.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment
Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\])
Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Adequate hematologic and organ function.

Criterios de exclusión

Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol
History of or current relevant CNS pathology, as described in the protocol
A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated
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
Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
Allergy/hypersensitivity to study drug, or excipients.

Intervenciones

drug

Odronextamab

Administered by intravenous (IV) infusion

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Ifosfamide

Administered by IV infusion, as part of the ICE ± R salvage therapy

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Carboplatin

Administered by IV infusion, as part of the ICE ± R salvage therapy

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Etoposide

Administered by IV infusion, as part of the ICE ± R salvage therapy

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Rituximab

Administered by IV infusion, as part of the ICE ± R, or DHAP ± R, or GDP ± R salvage therapy.

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Dexamethasone

Administered by IV, or orally (PO) as part of the DHAP ± R, or GDP ± R salvage therapy.

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Cisplatin

Administered by IV infusion, as part of the DHAP ± R or GDP +/-R salvage therapy.

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Cytarabine

Administered by IV infusion, as part of the DHAP ± R salvage therapy.

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