Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print Created with Sketch. YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Inicie sesión o únase ahora para utilizar esta función

Active, Not Recruiting

A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007) - 017007

Actualizada: 7 enero, 2022   |

Juno Therapeutics y Celgene son subsidiarias de Bristol-Myers Squibb Company

Imprimir Resumen

Imprima esta página y la guía del estudio para poder hablar mejor con su médico.
Use la guía de estudios para explorar el proceso de participación en un estudio clínico. Comprenda qué factores clave debe considerar antes de decidirse y piense preguntas para hacerle a su equipo de atención médica.

Detalles del estudio

  • Phase 2


  • Géneros

  • 18+

    Rango de edad

  • Active, Not Recruiting

Opciones de tratamiento

Brazos del estudio
Experimental: Lisocabtagene maraleucel
Biological: lisocabtagene maraleucel

Criterios clave de elegibilidad

Inclusion Criteria: - Age ≥ 18 years at the time of consent - Relapsed or refractory B-cell NHL of the following histologies: diffuse large B cell lymphoma (DLBCL) not otherwise specified; includes biopsy-confirmed transformed DLBCL from indolent histologies, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology, primary mediastinal B-cell lymphoma(PMBCL), and follicular lymphoma Grade 3B. Subjects must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have relapsed or refractory disease after at least 2 systemic lines of therapy for DLBCL or after auto-HSCT. - Positron-emission tomography-positive disease by Lugano Classification - Eastern Cooperative Oncology Group performance status of 0 to 1 - Adequate bone marrow, renal, hepatic, pulmonary, cardiac organ function - Adequate vascular access for leukapheresis procedure - Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy - Subjects must agree to use appropriate contraception. Exclusion Criteria: - Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study) - History of prior allogeneic hematopoietic stem cell transplant - Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis - History of another primary malignancy that has not been in remission for at least 2 years.The following are examples of exceptions from the 2-year limit: nonmelanoma skin cancer, definitively-treated stage 1 solid tumor with a low risk of recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on a Papanicolau smear. - Active hepatitis B or hepatitis C infection at the time of screening - History of or active human immunodeficiency virus infection at the time of screening - Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate anti-infection treatment at the time of leukapheresis or lisocabtagene maraleucel administration - Presence of acute or chronic graft-versus-host disease - History of clinically significant cardiac conditions within the past 6 months - History or presence of clinically relevant CNS pathology such as epilepsy/seizure, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis - Pregnant or nursing women - Subject does not meet protocol-specified washout periods for certain prior treatments - Prior CAR T-cell or other genetically modified T-cell therapy - Progressive vascular tumor invasion, thrombosis, or embolism - Venous thrombosis or embolism not managed on stable regimen of anticoagulation - Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 - Llame 855-907-3286 o Envíenos un correo electrónico

¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 -
Llame 855-907-3286 o Envíenos un correo electrónico