Estudio de fase 2, abierto, de 2 cohortes, de INCB050465,... | EligiMed

Estudio de fase 2, abierto, de 2 cohortes, de INCB050465, un inhibidor de PI3Kδ, en sujetos con linfoma de zona marginal recidivante o refractario con o sin exposición previa a un inhibidor de BTK (CITADEL-204)

CompletadoFase 2ClinicalTrials.gov

ID: NCT03144674Tipo: INTERVENTIONALInicio: 18 de dic de 2017Fin estimado: 29 de may de 2024

Resumen

El propósito de este estudio es evaluar la seguridad y eficacia de dos regímenes de tratamiento con parsaclisib en participantes diagnosticados con linfoma de zona marginal (LZM) recidivante o refractario que no han recibido previamente o fueron previamente tratados con un inhibidor de la tirosina quinasa de Bruton (BTK).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men and women, aged 18 or older (except in South Korea, aged 19 or older).
Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
Eastern Cooperative Oncology Group performance status 0 to 2.

Criterios de exclusión

Evidence of diffuse large B-cell transformation.
History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
Active graft versus host disease.
Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.

Intervenciones

drug

Parsaclisib

Parsaclisib at the protocol-defined dose.

Ubicaciones

Aou Maggiore Della Carita

Rosario, Argentina

Patrocinadores

PrincipalIncyte Corporation

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