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 Health Study Area: Breast 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

Recruiting

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Rituximab in Subjects With Relapsed or Refractory Non-hodgkin Lymphomas (R/R NHL) - CC-99282-NHL-001

Actualizada: 8 junio, 2021   |   ClinicalTrials.gov

Imprimir Resumen

¿ESTÁ CONSIDERANDO PARTICIPAR EN ESTE ESTUDIO?
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 1

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 26

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Administration of CC-99282
Drug: CC-99282
Experimental: CC-99282 + rituximab
Drug: CC-99282 Drug: rituximab

Criterios clave de elegibilidad

Inclusion Criteria: 1. Subject is ≥18 years of age at the time of signing the informed consent form (ICF). 2. Subject has a history of NHL with relapsed or refractory disease 3. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 4. Subjects must have the following laboratory values: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days (14 days if pegfilgastrim) 2. Hemoglobin (Hgb) ≥ 8 g/dL 3. Platelets (plt) ≥ 75 x 109/L without transfusion for 7 days 4. Serum bilirubin ≤ 1.5 x ULN (upper limit of normal). 5. AST/SGOT and ALT/SGPT ≤ 2.5X ULN 6. Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. 5. Agree to follow the CC-99282 Pregnancy Prevention Plan (PPP) Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: 1. Subject has life expectancy ≤ 2 months. 2. Subject has received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter. 3. Subject has symptomatic CNS involvement of disease (does not apply to PCNSL subjects in Part B). 4. Persistent diarrhea or malabsorption≥ Grade 2 , despite medical management 5. Subject is on chronic systemic immunosuppressive therapy or corticosteroids (eg, prednisone or equivalent not to exceed 10 mg per day within the last 14 days) or subjects with clinically significant graft-versus-host disease (GVHD). 6. Subject had prior autologous SCT ≤ 3 months prior to starting CC 99282. If subject had prior autologous SCT > 3 months prior to the start of CC-99282, any treatment-related toxicity is unresolved (grade > 1). 7. Subject had prior allogeneic SCT with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-99282. If subject had prior allogenic SCT > 6 months prior to the start of CC-99282, any treatment-related toxicity is unresolved (grade > 1). 8. Impaired cardiac function or clinically significant cardiac disease

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